Category Archives: Schering psychopharmacologic Asenapine schizophrenia EU

Well, on Schizophrenia, it works better than a placebo, at least. . . .

UPDATED 10.27.08 — Do go read Parts Two and Three of the Continuing Asenapine Chronicles. Follow the link.

This is at least one small relief, to the folks in Kenilworth — Schering’s psychopharmacologic agent, asenapine, has met the primary endpoint in a long-term schizophrenia relapse prevention trial. Asenapine, which is administered as a fast-dissolving sublingual tablet, is a psychopharmacologic compound for which Schering is seeking European/EU (and US FDA) approval. It was only filed as an NDA with the FDA in June of 2008 Q4 2007 (and, as an obviously well-experienced, putatively anonymous commenter below notes, it may have a some basic science/side-effect concerns ahead of it) — so this product is likely still at least three or more years away from the US market, at the moment.

In any event, quoth today’s Schering press release:

. . . .Asenapine was statistically significantly more effective than placebo in preventing relapse, the primary endpoint of the trial. Asenapine was generally well tolerated during the trial. Full results of the trial, including efficacy, safety and tolerability data will be presented at a later date. These data are planned to be used to support a regulatory submission for the approval of asenapine in Europe. . . .

And still the stock swoon continues — Schering is down below $12.20, in mid-afternoon trading, on the NYSE — under heavy volume flow.