New atypical AP: Saphris (asenapine)

[Luna]

NEW YORK, Aug 14 (Reuters)

Schering-Plough Corp (SGP.N) said on Friday that U.S. regulators had approved its Saphris antipsychotic drug, adding a potential blockbuster product as the company is soon to be bought by Merck & Co (MRK.N).

The Food and Drug Administration cleared Saphris for acute treatment of schizophrenia in adults and for episodes associated with the severe bipolar I disorder. The drug, also known as asenapine, is expected to be available in the fourth quarter, Schering said.

"This is the first time a drug has been approved for both indications at once," said Schering-Plough spokesman Robert Consalvo.

It will compete with standard treatments that in past years won separate approvals for both schizophrenia and bipolar disorder, including Johnson & Johnson's (JNJ.N) Risperdal, Bristol-Myers Squibb Co's (BMY.N) Abilify and Eli Lilly and Co's (LLY.N) Zyprexa.

But unlike widely used older treatments, which are approved for both short-term treatment and long-term control of schizophrenia, the Schering-Plough medicine is approved only for acute short-term treatment.

Schering has projected sales of Saphris could exceed $1 billion a year. It acquired the drug in its purchase in 2007 of Organon BioSciences.

Organon had been developing the drug with Pfizer Inc (PFE.N) but acquired full rights to the drug in 2006 when Pfizer abandoned it because of commercial considerations.

Saphris is a type of atypical antipsychotic, a class of drugs that target various brain receptors. Such drugs have raised some concerns over their side effects, which can include problems with weight gain, metabolism and blood fat levels.

But company studies showed fewer patients given Saphris gained weight or saw higher cholesterol levels compared with rival drugs, Schering has said.

The approval comes after an FDA advisory panel in July backed Saphris as a safe and effective therapy for the two mood illnesses.

Merck said in March that it would buy Schering for $41 billion. The deal won shareholder approval last week, and the companies said it remained on track to close in the fourth quarter.

Shares of Merck and Schering-Plough fell moderately on Friday, in line with a 0.4 percent decline for the New York Stock Exchange Arca Pharmaceutical Index of large U.S. and European drugmakers. (Reporting by Lewis Krauskopf; Editing by Lisa Von Ahn and Steve Orlofsky)

© Thomson Reuters 2009 All rights reserved
http://www.reuters.com/article/rbssHeal ... 0120090814

[Native Arizona]

A short-term medication for a life long disease no matter which one you pick (schizo or bp). Yeah - that is going to save the world! My question is - and then what once you have to discontinue the med?

[Zooie]

Some more info on Saphris from PsychCentral. Sounds like the same-ole, same-ole antipsychotic SEs. (Can we ever get away from weigh gain???)


Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA?s strongest warning. The warning alerts doctors who prescribe the medication about an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason).

Saphris is not approved for these patients and should not be prescribed in such a manner.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Saphris is manufactured by Schering-Plough, Kenilworth, N.J.

Source: FDA news release

[Muddler]

Wouldn't it be nice if they could find an AP without the usual SE's. I guess Seroquel has made so much money every manufacturer wants an AP of their own.

[Luna]

Yeah, atypicals are huge cash cows because they KNOW we have to be on them in the long-term. It does seem to indicate that there would be less weight gain, comparatively. It seems that the newer the drug, the less weight gain is associated with it (although of course none of them are weight-neutral.) And given individual variations, it's likely at least some of us will experience weight gain.

Native Arizona, how I hear you! So Saphris will be useful to knock acute mania out of you, but that's it. The approval is for sublingual tablets, so fast absorption. But really, I wonder if it won't just be used for maintenance anyway, off-label. If you scour through package inserts of some of the atypical APs we're already taking for maintenance, you'll sometimes see a small mention that 'safety has not been established beyond 12 weeks' (or 8 weeks, whatever) because that was the duration of a trial. To cover the company's ass. But we just seem to stay on them and stay on them...

The BIG RED FLAG for me, personally is that akathisia is higher on the 'commonly reported SEs' list, than usual for atypicals. I mean have these people ever TRIED coping with a bad case of akathisia??

Interesting name, 'Saphris'. If 'Geodon' implies coming 'down' (don) to 'earth' (geo). And Abilify is... well, obvious, (does anyone else find that name patronising?) - what could Saphris be about?

Luna,
widening and rounding on Seroquel.