Adult SSRI Use & Suicidality To Get Committee Review In Next Few Months, J&J Says

[Guest guest]

Thanks to Gloria and Ann Blake for forwarding the following:

Adult SSRI Use And Suicidality To Get Committee Review In Next Few Months,

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 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.

FDA requested the black box class warning following a recommendation by the

agency’s Psychopharmacologic Drugs & Pediatric Advisory Committees in

September.

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.

To arrange for a webcast of this meeting or live videoconferencing, or to

order videotapes & DVDs, email webcasthelp@... or call

800-627-8171.

[Guest guest]

Thanks to Gloria and Ann Blake for forwarding the following:

Adult SSRI Use And Suicidality To Get Committee Review In Next Few Months,

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 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.

FDA requested the black box class warning following a recommendation by the

agency’s Psychopharmacologic Drugs & Pediatric Advisory Committees in

September.

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.

To arrange for a webcast of this meeting or live videoconferencing, or to

order videotapes & DVDs, email webcasthelp@... or call

800-627-8171.

[Guest guest]

Thanks to Gloria and Ann Blake for forwarding the following:

Adult SSRI Use And Suicidality To Get Committee Review In Next Few Months,

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 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.

FDA requested the black box class warning following a recommendation by the

agency’s Psychopharmacologic Drugs & Pediatric Advisory Committees in

September.

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.

To arrange for a webcast of this meeting or live videoconferencing, or to

order videotapes & DVDs, email webcasthelp@... or call

800-627-8171.

[Guest guest]

Thanks to Gloria and Ann Blake for forwarding the following:

Adult SSRI Use And Suicidality To Get Committee Review In Next Few Months,

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 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.

FDA requested the black box class warning following a recommendation by the

agency’s Psychopharmacologic Drugs & Pediatric Advisory Committees in

September.

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.

To arrange for a webcast of this meeting or live videoconferencing, or to

order videotapes & DVDs, email webcasthelp@... or call

800-627-8171.