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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Babbler20 on June 18, 2014, at 22:22:02
Does anyone know when Suvorexant will be hitting the market?
Posted by jrbecker76 on June 25, 2014, at 12:03:38
In reply to Suvorexant Updates, anyone?, posted by Babbler20 on June 18, 2014, at 22:22:02
> Does anyone know when Suvorexant will be hitting the market?
The NDA was resubmitted earlier this year, and then announced as accepted by the FDA in April. Per PDUFA rules, the FDA is supposed to respond within six months, so look for an FDA response in the third quarter.
Suvorexant will undoubtedly be an interesting new drug in the hypnotic category given that it represents an entirely new class known as orexin antagonists. However, there should be some caution in prescribing it to those with co-morbid psychiatric diagnoses. In clinical trials, suvorexant subjects were found to have a slightly higher but significant incidence of suicidal ideation (but not depression) in comparison with placebo. If it is approved, further consumer experience will hopefully provide more insight on this risk.
Posted by babbler20 on July 14, 2014, at 0:03:21
In reply to Re: Suvorexant Updates, anyone? » Babbler20, posted by jrbecker76 on June 25, 2014, at 12:03:38
Thanks so much for the update Jrbecker. Hopefully Suvorexant will see the light of day eventually.
This is the end of the thread.
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