FDA has canceled the Psychopharmacologic Drugs Advisory Committee review of Johnson & Johnson's paliperidone extended-release OROS scheduled for Sept. 7, the company announced July 21.

"The cancellation came at the request of the Division of Psychiatry Products after communicating it had not identified any issues at this time requiring Advisory Committee feedback," J&J said.

The meeting had been scheduled for just weeks before paliperidone ER OROS' late September user fee date for the treatment of schizophrenia (¹ Also see "J&J Paliperidone ER To Go Before Advisory Panel Weeks Before User Fee Date" - Pink Sheet, 19 July, 2006.). J&J said it still anticipates a decision by late September.

Besides announcing the cancellation, J&J also said it is currently conducting two Phase III head-to-head trials of the drug versus AstraZeneca's Seroquel (quetiapine) and placebo in both schizophrenia and bipolar one disorder.

In a second quarter earnings call July 18, J&J Pharmaceuticals Worldwide Chairman Joseph Scodari had mistakenly said comparative trials are not yet underway.

AstraZeneca is trailing slightly behind J&J with a once-a-day antipsychotic: the firm's sustained-release Seroquel has a May 17, 2007 user fee date (² Also see "Seroquel SR NDA Submitted For Schizophrenia" - Pink Sheet, 18 July, 2006.).

-Daniel Fowler

FDA Cancels Advisory Committee Meeting On J&amp;J’s Paliperidone ER

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FDA Cancels Advisory Committee Meeting On J&J’s Paliperidone ER