Asenapine (Saphris) looks promising

[search4answers]

Asenapine (Saphris) is a new atypical antipsychotic under development for the treatment of schizophrenia and acute mania associated with bipolar disorder by Schering-Plough after its November 19, 2007 merge with Organon International. Development of the drug, through Phase III trials, began while Organon was still a part of Akzo Nobel.^[1] Preliminary data indicate that it has minimal anticholinergic and cardiovascular side effects, as well as minimal weight gain. Over 3000 patients have participated in clinical trials of asenapine, and the FDA accepted the manufacturer's NDA on November 26, 2007 for standard review. ^[2]

^"Prolactin levels were higher in the risperidone group (79%) than in the asenapine or placebo groups (9% and 2%, respectively). Asenapine-treated patients reported a lower rate of clinically significant weight gain versus risperidone-treated patients (4.3% versus 17%, 1.9% for placebo). "

http://www.redorbit.com/news/health/114558...tudy/index.html

some hope maybe....?

[tryp]

Wow, another new atypical?

I found [link=http://www.forbes.com/2009/01/14/schering-plough-closer-markets-equity-cx_lal_0114markets33.html" target="_blank]this[/link] article on the recent developments - the FDA's complete response letter requesting more data.

The molecular structure looks a lot like Clozaril - much more compact than the other APs. Not that that means anything - just interesting.

[search4answers]

Wow, another new atypical?

I found [link=http://www.forbes.com/2009/01/14/schering-plough-closer-markets-equity-cx_lal_0114markets33.html" target="_blank]this[/link] article on the recent developments - the FDA's complete response letter requesting more data.

The molecular structure looks a lot like Clozaril - much more compact than the other APs. Not that that means anything - just interesting.

After reading that article I hope politics doesn't get in the way of scientific developments.

[Aurochs]

Hmm. tryp pointed me to this article, which goes over some of the data presented at a meeting of the American Psychiatric Association. They say that asenapine was "noninferior to olanzapine" in reducing mania symptoms. This may seem promising, but keep in mind that olanzapine and risperidone also showed similar efficacy in reducing symptoms of mania.

On the schizophrenia side, four trials were conducted. Two were positive (they showed that asenapine was superior to placebo), but I see no evidence that an active control was used in either one. One schizophrenia trial failed - neither the asenapine group nor the olanzapine group differed significantly from the placebo group. One schizophrenia trial was negative - the asenapine group didn't differ from the placebo group, but the olanzapine group did.

Finally, in terms of side effects, the presenters gleefully proclaim:

We are encouraged that in the long-term trial, asenapine had a lower incidence of clinically significant weight gain (15%) vs olanzapine (36%).

So that's good, and there's no sign of QTc prolongation like that found with iloperidone. At least it doesn't seem to have evil SEs.

Overall, asenapine's commercial prospects seem to be better than iloperidone's, but not because it's more effective than something currently on the market. It's because of its extra indication for bipolar mania and its more mild side effects compared to iloperidone.

[Generica]

Oh cool, that does sound promising. Give it another 10 years after approval in the US, & it might become available in Australia for schizophrenia. Another 10 years after that, and they might also subsidise it for bipolar!

Oh well, we may be behind, but at least we get to learn about long term side effects from people in other countries

Be interested to watch further developments in relation to this new drug.