Posted by jrbecker on May 29, 2003, at 10:21:13
In reply to SLEEP meds update , posted by jrbecker on May 21, 2003, at 13:13:09
Sepracor's new sleep drug, Estorra, for chronic insomnia, has a Prescription Drug User Fee Act goal date of Nov 30th. This means the FDA review process is set to make a decision at this time. Hopefully, approval will soon follow after that. Estorra is in the same class as Ambien and Sonata but is supposed to have a much higher affinity for GABA modulation, and thus, a more effective drug for sleep maintenance.
> A few new sleep meds will be hitting the market within a year's time. All are non-benzo's like Sonata or Ambien. However, these new compounds are claiming more effectiveness in treating transient as well as chronic insomnia. Further improvement is seen in addressing not only problems with sleep initiation but also sleep maintenance (staying asleep).
>
> Indiplon from Neurocrine (IR and MR formulations)
> Phase III complete, planning NDA in early '04
> http://www.neurocrine.com/ar02/indiplon.html
> http://www.biospace.com/news_story.cfm?StoryID=12713520&full=1
>
>
> Eszopiclone (ESTORRA) from Sepracor
> NDA submitted to FDA in 5/03
> http://www.sepracor.com/pharm/
> http://www.biospace.com/news_story.cfm?StoryID=12722520&full=1
>
>
> Zolpidem MR (Ambien sustained-release version)
> Phase III trials wrapping up. NDA planned for early '04.
>
>
poster:jrbecker
thread:228087
URL: http://www.dr-bob.org/babble/20030525/msgs/229925.html