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.
3 comments:
Asenapine was filed over a year ago. It should have been approved already, yet nothing has been announced. When you have an add on a study like this with no news on an approval and safety data to come out at a later time. It points to major safety issues with a drug. Since structurally similar compounds with major safety issues are marketed i.e. Zyprexa and even Clozapine with restricted access, this points to potentially hug safety issues. Another study carefuly designed with exclusion of certain subjects (e.g. bipolar) may be intended to dilute out and obfuscate serious adverse effects.
Schering's Press Release from last year follows (editted out info on the illnesses themselves):
Date:11/25/2007[Outline] [RSS & Subscription]
KENILWORTH, N.J., Nov. 26 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet. Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar I Disorder. In accepting the NDA, the FDA indicated that asenapine will receive a standard review.
The clinical trial program thus far has consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients.
Schering-Plough acquired asenapine through its combination with Organon BioSciences on november 19, 2007.
SOURCE Schering-Plough Corporation
Copyright©2007 PR Newswire.
All rights reserved
Thank you -- of course -- for correcting my error.
What you wrote makes sense, as in a prior life, I was around for the initial FDA approvals of old Sandoz Clozaril (Clozapine).
For what its worth, I misread the Schering "Product Pipeline" Sheet -- on the Schering Investor Publications portion of the website -- it listed the candidate among those "New Entities" as of June 2008:
Phase III (New Entities)
Regulatory Application Filed (New Entities)
Asenapine -- Schizophrenia (U.S.) Bipolar Mania Disorder (U.S.)
CLARITIN/Singulair2 -- Seasonal Allergic Rhinitis (U.S.)
R Golimumab (CNTO 148)1 -- Rheumatoid Arthritis
Ankylosing Spondylitis Psoriatic Arthritis
* Sugammadex -- Anesthesia (U.S., EU, Japan)
June 2008
~~~~~~~~~~~~
Only the asterisked candidate was new, apparently.
As always, thanks for your keen insight, Salmon(?), or "Anonymous" poster. . . .
Namaste
For what it's worth. This study appears to be the same one that was the results were reported on towards the end of last May or early June. If that's the case then SP should have already had more than enough time to complete their analysis of safety data and to submit the results during the present review cycle. If there is a safety issue especially in bipolar this study would dilute the overall incidence rates.
I looked at SP's press release and it was a 6 month placebo controlled study in 700 people at doses of 5 mg and 10 mg with only about 380 people on asenapine with some sort of run in period that made no sense and may indicate they were screening out people (e.g. who switched meds from an active control during acute treatment) and either lost efficacy or then had toxicities on asenapine.
If half the people on asenapine received 5 mg and half 10 mg then only about 165 people got the higher dose. Based on this you can't even be guarenteed to see even a single case of a serious dose related toxicity that occurs in 1% of people. Plus this says nothing of cumulative toxicites that show up after 6 months. Since there's no active comparator (the most obvious would be Zyprexa) you can't even tell if it's less safe than Zyprexa which is likely also intentional.
Overall things look very fishy.
Salmon
Post a Comment