Re: Adult SSRI Use And Suicidality To Get FDA Advisory Committee Review

[Guest guest]

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

Yeah! I an excited about this. I hope they take public testimony.

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

Yeah! I an excited about this. I hope they take public testimony.

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

Yeah! I an excited about this. I hope they take public testimony.

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

Yeah! I an excited about this. I hope they take public testimony.

It's about time!Hopefully this this start of admitting the adverse

effects of ssri's in adults as well as children.

> ==============================================================

> " The Pink Sheet " D A I L Y :: May 26, 2005

> --------------------------------------------------------------

>

> BREAKING NEWS:

>

>

> >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> Review, J & J Says

>

>

> FDA will convene an advisory committee within the next few months to

> assess the risk of suicidality in adults using selective serotonin

> reuptake inhibitors, & Senior VP and Therapeutic

Area

> Head-Internal Medicine Joanne Waldstreicher said May 26.

>

> " There is going to be an FDA advisory committee within the next few

> months to review SSRIs and suicidality in adults, " Waldstreicher

said

> during the company's R & D day in New York.

>

> J & J submitted an NDA for its SSRI dapoxetine in December ( " The Pink

> Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> ejaculation indication for the product.

>

> An advisory committee meeting on SSRI use and adult suicidality

would

> have implications for most of the major products in the

antidepressant

> category, including Forest's Lexapro, Celexa and generics;

> GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> versions of Bristol-Myers Squibb's Serzone.

>

> The meeting also would likely impact the two approved serotonin and

> norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

Effexor.

>

> All antidepressants now carry a " black box " warning and other

language

> concerning the risk of pediatric suicidality ( " The Pink Sheet "

DAILY,

> March 4, 2005).

>

> FDA requested the black box class warning following a recommendation

> by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

>

> Dapoxetine's label presumably would have to include the same black

box

> warning.

>

> Nevertheless, J & J is attempting to differentiate dapoxetine from the

> rest of the SSRI class.

>

> " There are lots of SSRIs on the market but dapoxetine is different, "

> Waldstreicher said. " It has a different pharmacokinetic profile.

> Dapoxetine has a fast onset of action, peaks at a little more than

an

> hour and is rapidly cleared. This makes the drug ideal for as-needed

> dosing rather than needing to take it on a daily basis. "

>

> " This is unlike the long-acting SSRIs, which are already on the

market

> for other conditions like depression, where the drug hangs around

for

> a long period of time and accumulates, " she said.

>

> In dapoxetine clinical trials there were no adverse events related

to

> suicide, Waldstreicher noted.

>

> " In our Phase III pivotal U.S. trials in over 3,000 men we have seen

> no suicide-related adverse events, " she said.

>

> Dapoxetine is undergoing a standard review at FDA, with an estimated

> user fee deadline of Oct. 27.

>

> The company expects an advisory committee review of the dapoxetine

NDA

> separate from the SSRI class review on adult suicidality.

>

> - Shelton

>

>

> For more current and breaking industry news go to:

> <http://www.ThePinkSheetDAILY.com>

[Guest guest]

I would love to testify AGAIN at an FDA hearing! This time would be

the represent the thousands of adults that I speak to daily! Lets

hope for a pubic forum.

> > ==============================================================

> > " The Pink Sheet " D A I L Y :: May 26, 2005

> > --------------------------------------------------------------

> >

> > BREAKING NEWS:

> >

> >

> > >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> > Review, J & J Says

> >

> >

> > FDA will convene an advisory committee within the next few months

to

> > assess the risk of suicidality in adults using selective serotonin

> > reuptake inhibitors, & Senior VP and Therapeutic

> Area

> > Head-Internal Medicine Joanne Waldstreicher said May 26.

> >

> > " There is going to be an FDA advisory committee within the next

few

> > months to review SSRIs and suicidality in adults, " Waldstreicher

> said

> > during the company's R & D day in New York.

> >

> > J & J submitted an NDA for its SSRI dapoxetine in December ( " The

Pink

> > Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> > ejaculation indication for the product.

> >

> > An advisory committee meeting on SSRI use and adult suicidality

> would

> > have implications for most of the major products in the

> antidepressant

> > category, including Forest's Lexapro, Celexa and generics;

> > GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> > Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> > versions of Bristol-Myers Squibb's Serzone.

> >

> > The meeting also would likely impact the two approved serotonin

and

> > norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

> Effexor.

> >

> > All antidepressants now carry a " black box " warning and other

> language

> > concerning the risk of pediatric suicidality ( " The Pink Sheet "

> DAILY,

> > March 4, 2005).

> >

> > FDA requested the black box class warning following a

recommendation

> > by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> > Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

> >

> > Dapoxetine's label presumably would have to include the same

black

> box

> > warning.

> >

> > Nevertheless, J & J is attempting to differentiate dapoxetine from

the

> > rest of the SSRI class.

> >

> > " There are lots of SSRIs on the market but dapoxetine is

different, "

> > Waldstreicher said. " It has a different pharmacokinetic profile.

> > Dapoxetine has a fast onset of action, peaks at a little more

than

> an

> > hour and is rapidly cleared. This makes the drug ideal for as-

needed

> > dosing rather than needing to take it on a daily basis. "

> >

> > " This is unlike the long-acting SSRIs, which are already on the

> market

> > for other conditions like depression, where the drug hangs around

> for

> > a long period of time and accumulates, " she said.

> >

> > In dapoxetine clinical trials there were no adverse events

related

> to

> > suicide, Waldstreicher noted.

> >

> > " In our Phase III pivotal U.S. trials in over 3,000 men we have

seen

> > no suicide-related adverse events, " she said.

> >

> > Dapoxetine is undergoing a standard review at FDA, with an

estimated

> > user fee deadline of Oct. 27.

> >

> > The company expects an advisory committee review of the

dapoxetine

> NDA

> > separate from the SSRI class review on adult suicidality.

> >

> > - Shelton

> >

> >

> > For more current and breaking industry news go to:

> > <http://www.ThePinkSheetDAILY.com>

>

>

>

>

>

>

>

[Guest guest]

I would love to testify AGAIN at an FDA hearing! This time would be

the represent the thousands of adults that I speak to daily! Lets

hope for a pubic forum.

> > ==============================================================

> > " The Pink Sheet " D A I L Y :: May 26, 2005

> > --------------------------------------------------------------

> >

> > BREAKING NEWS:

> >

> >

> > >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> > Review, J & J Says

> >

> >

> > FDA will convene an advisory committee within the next few months

to

> > assess the risk of suicidality in adults using selective serotonin

> > reuptake inhibitors, & Senior VP and Therapeutic

> Area

> > Head-Internal Medicine Joanne Waldstreicher said May 26.

> >

> > " There is going to be an FDA advisory committee within the next

few

> > months to review SSRIs and suicidality in adults, " Waldstreicher

> said

> > during the company's R & D day in New York.

> >

> > J & J submitted an NDA for its SSRI dapoxetine in December ( " The

Pink

> > Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> > ejaculation indication for the product.

> >

> > An advisory committee meeting on SSRI use and adult suicidality

> would

> > have implications for most of the major products in the

> antidepressant

> > category, including Forest's Lexapro, Celexa and generics;

> > GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> > Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> > versions of Bristol-Myers Squibb's Serzone.

> >

> > The meeting also would likely impact the two approved serotonin

and

> > norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

> Effexor.

> >

> > All antidepressants now carry a " black box " warning and other

> language

> > concerning the risk of pediatric suicidality ( " The Pink Sheet "

> DAILY,

> > March 4, 2005).

> >

> > FDA requested the black box class warning following a

recommendation

> > by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> > Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

> >

> > Dapoxetine's label presumably would have to include the same

black

> box

> > warning.

> >

> > Nevertheless, J & J is attempting to differentiate dapoxetine from

the

> > rest of the SSRI class.

> >

> > " There are lots of SSRIs on the market but dapoxetine is

different, "

> > Waldstreicher said. " It has a different pharmacokinetic profile.

> > Dapoxetine has a fast onset of action, peaks at a little more

than

> an

> > hour and is rapidly cleared. This makes the drug ideal for as-

needed

> > dosing rather than needing to take it on a daily basis. "

> >

> > " This is unlike the long-acting SSRIs, which are already on the

> market

> > for other conditions like depression, where the drug hangs around

> for

> > a long period of time and accumulates, " she said.

> >

> > In dapoxetine clinical trials there were no adverse events

related

> to

> > suicide, Waldstreicher noted.

> >

> > " In our Phase III pivotal U.S. trials in over 3,000 men we have

seen

> > no suicide-related adverse events, " she said.

> >

> > Dapoxetine is undergoing a standard review at FDA, with an

estimated

> > user fee deadline of Oct. 27.

> >

> > The company expects an advisory committee review of the

dapoxetine

> NDA

> > separate from the SSRI class review on adult suicidality.

> >

> > - Shelton

> >

> >

> > For more current and breaking industry news go to:

> > <http://www.ThePinkSheetDAILY.com>

>

>

>

>

>

>

>

[Guest guest]

I would love to testify AGAIN at an FDA hearing! This time would be

the represent the thousands of adults that I speak to daily! Lets

hope for a pubic forum.

> > ==============================================================

> > " The Pink Sheet " D A I L Y :: May 26, 2005

> > --------------------------------------------------------------

> >

> > BREAKING NEWS:

> >

> >

> > >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> > Review, J & J Says

> >

> >

> > FDA will convene an advisory committee within the next few months

to

> > assess the risk of suicidality in adults using selective serotonin

> > reuptake inhibitors, & Senior VP and Therapeutic

> Area

> > Head-Internal Medicine Joanne Waldstreicher said May 26.

> >

> > " There is going to be an FDA advisory committee within the next

few

> > months to review SSRIs and suicidality in adults, " Waldstreicher

> said

> > during the company's R & D day in New York.

> >

> > J & J submitted an NDA for its SSRI dapoxetine in December ( " The

Pink

> > Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> > ejaculation indication for the product.

> >

> > An advisory committee meeting on SSRI use and adult suicidality

> would

> > have implications for most of the major products in the

> antidepressant

> > category, including Forest's Lexapro, Celexa and generics;

> > GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> > Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> > versions of Bristol-Myers Squibb's Serzone.

> >

> > The meeting also would likely impact the two approved serotonin

and

> > norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

> Effexor.

> >

> > All antidepressants now carry a " black box " warning and other

> language

> > concerning the risk of pediatric suicidality ( " The Pink Sheet "

> DAILY,

> > March 4, 2005).

> >

> > FDA requested the black box class warning following a

recommendation

> > by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> > Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

> >

> > Dapoxetine's label presumably would have to include the same

black

> box

> > warning.

> >

> > Nevertheless, J & J is attempting to differentiate dapoxetine from

the

> > rest of the SSRI class.

> >

> > " There are lots of SSRIs on the market but dapoxetine is

different, "

> > Waldstreicher said. " It has a different pharmacokinetic profile.

> > Dapoxetine has a fast onset of action, peaks at a little more

than

> an

> > hour and is rapidly cleared. This makes the drug ideal for as-

needed

> > dosing rather than needing to take it on a daily basis. "

> >

> > " This is unlike the long-acting SSRIs, which are already on the

> market

> > for other conditions like depression, where the drug hangs around

> for

> > a long period of time and accumulates, " she said.

> >

> > In dapoxetine clinical trials there were no adverse events

related

> to

> > suicide, Waldstreicher noted.

> >

> > " In our Phase III pivotal U.S. trials in over 3,000 men we have

seen

> > no suicide-related adverse events, " she said.

> >

> > Dapoxetine is undergoing a standard review at FDA, with an

estimated

> > user fee deadline of Oct. 27.

> >

> > The company expects an advisory committee review of the

dapoxetine

> NDA

> > separate from the SSRI class review on adult suicidality.

> >

> > - Shelton

> >

> >

> > For more current and breaking industry news go to:

> > <http://www.ThePinkSheetDAILY.com>

>

>

>

>

>

>

>

[Guest guest]

I would love to testify AGAIN at an FDA hearing! This time would be

the represent the thousands of adults that I speak to daily! Lets

hope for a pubic forum.

> > ==============================================================

> > " The Pink Sheet " D A I L Y :: May 26, 2005

> > --------------------------------------------------------------

> >

> > BREAKING NEWS:

> >

> >

> > >>>> Adult SSRI Use And Suicidality To Get FDA Advisory Committee

> > Review, J & J Says

> >

> >

> > FDA will convene an advisory committee within the next few months

to

> > assess the risk of suicidality in adults using selective serotonin

> > reuptake inhibitors, & Senior VP and Therapeutic

> Area

> > Head-Internal Medicine Joanne Waldstreicher said May 26.

> >

> > " There is going to be an FDA advisory committee within the next

few

> > months to review SSRIs and suicidality in adults, " Waldstreicher

> said

> > during the company's R & D day in New York.

> >

> > J & J submitted an NDA for its SSRI dapoxetine in December ( " The

Pink

> > Sheet " DAILY, Dec. 28, 2004). The company is seeking a premature

> > ejaculation indication for the product.

> >

> > An advisory committee meeting on SSRI use and adult suicidality

> would

> > have implications for most of the major products in the

> antidepressant

> > category, including Forest's Lexapro, Celexa and generics;

> > GlaxoKline's Paxil CR and Paxil generics; Lilly's Symbyax and

> > Prozac generics; Pfizer's Zoloft; Organon's Remeron; and generic

> > versions of Bristol-Myers Squibb's Serzone.

> >

> > The meeting also would likely impact the two approved serotonin

and

> > norepinephrine reuptake inhibitors: Lilly's Cymbalta and Wyeth's

> Effexor.

> >

> > All antidepressants now carry a " black box " warning and other

> language

> > concerning the risk of pediatric suicidality ( " The Pink Sheet "

> DAILY,

> > March 4, 2005).

> >

> > FDA requested the black box class warning following a

recommendation

> > by the agency's Psychopharmacologic Drugs & Pediatric Advisory

> > Committees in September ( " The Pink Sheet " DAILY, Sept. 14, 2004).

> >

> > Dapoxetine's label presumably would have to include the same

black

> box

> > warning.

> >

> > Nevertheless, J & J is attempting to differentiate dapoxetine from

the

> > rest of the SSRI class.

> >

> > " There are lots of SSRIs on the market but dapoxetine is

different, "

> > Waldstreicher said. " It has a different pharmacokinetic profile.

> > Dapoxetine has a fast onset of action, peaks at a little more

than

> an

> > hour and is rapidly cleared. This makes the drug ideal for as-

needed

> > dosing rather than needing to take it on a daily basis. "

> >

> > " This is unlike the long-acting SSRIs, which are already on the

> market

> > for other conditions like depression, where the drug hangs around

> for

> > a long period of time and accumulates, " she said.

> >

> > In dapoxetine clinical trials there were no adverse events

related

> to

> > suicide, Waldstreicher noted.

> >

> > " In our Phase III pivotal U.S. trials in over 3,000 men we have

seen

> > no suicide-related adverse events, " she said.

> >

> > Dapoxetine is undergoing a standard review at FDA, with an

estimated

> > user fee deadline of Oct. 27.

> >

> > The company expects an advisory committee review of the

dapoxetine

> NDA

> > separate from the SSRI class review on adult suicidality.

> >

> > - Shelton

> >

> >

> > For more current and breaking industry news go to:

> > <http://www.ThePinkSheetDAILY.com>

>

>

>

>

>

>

>