Posted by jrbecker on June 30, 2003, at 15:43:51
In reply to Re: Webcast on newer anxiety meds, posted by utopizen on June 30, 2003, at 14:57:04
Right, but you're forgetting about Estorra though. It has a Prescription Drug User Fee Act date of late Nov '03. My old professor from college, Dr. Mary Carskodon did some of the research on this drug and sees it as a big improvement on Ambien and Sonata. Estorra is significantly more potent than either and also has a longer half-life, so it has my vote over these other two currently on the market.
As for Indiplon vs. Estorra, the former could potentially unveil itself as having a slightly better profile. I'm basing this on Pfizer's decision to opt into Indiplon instead of Estorra despite knowing that Estorra's R&D timeline would allow it to hit the market at least a full 6 months earlier. For Indiplon, they are having to test both a regular and extended-release formulation since its half-life is very short-lived.
After hearing the presentation, I'm fairly intrigued by the anxiolytic Ocinaplon. The data showed it had remarkably no sedation but a very potent anti-anxiety effect. Although there was no head-to-head study of the two, ocinaplon had a much better efficacy and side effect ratio than Pregabalin or Ativan did against placebo in Pregabalin's own trials. Unfortunately, we won't be seeing Ocinaplon any time soon. And it's actually not the Phase III trials (which are beginning presently) that will be holding it up from NDA status. A 2-year carcinogenicity trial that was initiated this spring will really be the thing that will drag the pre-market period out until 2005. So...fall 2005 is probably the earliest we can hope for. Perhaps Indevus's pagoclone will have more luck in reaching market before then.
JB
> Indiplon may be submitted for an NDA by next year, but the company doesn't expect it to be out until at least 2005. Same with all other pipeline sleep meds, including Ambien MR (Modified Release). Indiplon looks promising. Could be first drug to be approved for sleep in long-term without a habit-forming warning, but this is up to the FDA and the maker's clinical trials (1+yr/patient monitoring) efforts.
poster:jrbecker
thread:238127
URL: http://www.dr-bob.org/babble/20030624/msgs/238179.html