Johnson & Johnson's extended-release formulation of paliperidone will go before FDA's Psychopharmacologic Drugs Advisory Committee Sept. 7, the company said.

The meeting comes just weeks before the late September user fee date for paliperidone ER OROS for the treatment of schizophrenia (¹ Also see "J&J Submits Paliperidone ER" - Pink Sheet, 30 November, 2005.).

J&J will likely highlight to the committee the safety and tolerability results from Phase III trials.

"We have...a very low peak-to-trough ratio when compared to the immediate-relief formulation of [the firm's] Risperdal ," J&J Pharmaceuticals Worldwide Chairman Joseph Scodari said during a second quarter earnings call July 18.

"Eliminating this variability is beneficial because side effects are usually associated with the peaks and a decrease in efficacy with the troughs."

For example, during day 4 of one study, the mean plasma concentration for paliperidone ER patients ranged from approximately 32 ng/ml to 39 ng/ml, compared to roughly 15 ng/ml to 48 ng/ml for Risperdal (risperidone) immediate-release patients, according to the company.

Scodari said the firm has also seen positive efficacy associated with paliperidone ER, including an improved relapse rate.

On day 280 of another study, roughly 67% of patients receiving paliperidone ER had not experienced a relapse, compared to approximately 21% in the placebo arm.

Scodari said J&J is "actively considering" Phase IIIb and Phase IV studies, and could pit paliperidone ER against AstraZeneca's Seroquel (quetiapine) in head-to-head trials.

He emphasized that a comparative trial of paliperidone ER versus Seroquel IR is not underway. However, "that's not to say we won't consider and ultimately implement such trials," Scodari said.

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

"Clearly we'll have a fairly substantial lead in the marketplace in terms of offering a true once-a-day," Scodari said.

-Daniel Fowler

J&amp;J Paliperidone ER To Go Before Advisory Panel Weeks Before User Fee Date

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J&J Paliperidone ER To Go Before Advisory Panel Weeks Before User Fee Date