Adult SSRI Use And Suicidality To Get FDA Advisory Committee Review

May 26, 2005

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

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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

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May 26, 2005