Wyeth’s new antipsychotic receives FDA non-approvable letter after fatality
August 13, 2007
The US FDA has issued a non-approvable letter for Wyeth/Solvay’s new-generation atypical antipsychotic bifeprunox, which was under review for the acute treatment of schizophrenia and the maintenance of stable adult patients.
Wyeth’s share price on teh New York Stock Exchange closed at $46.59, down by 6% on August 10th. (emphasis mine)
OK, it may just be a typo, but I’d like to think it’s an oh-so-hip ironic reference to Teh NYSE.
I will inflict you with a little sidebar on the drug…just because I can:
The majority of atypical antipsychotics on the market are dopamine receptor antagonists. Bifeprunox is a partial agonist of the D2 dopamine receptor, a G-protein coupled receptor (GPCR). Like aripiprazole (Abilify), another D2 partial agonist, bifeprunox is believed to act as a dopamine stabilizer, that is, decreasing overactive dopaminergic response in some areas of the brain and increasing it in others.
The FDA issued the non-approval letter because of a patient’s death (multi-organ failure) in an acute (six-week) trial. It was noted that the case was complex and that it is not known if the patient’s death was related to the drug.
Yeah, so that explanation of D2 partial agonists was teh lame. You know what I have to say to that?