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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by herpills on November 12, 2012, at 21:48:58
New York Business Journal
Date: Thursday, November 8, 2012, 2:44pm ESTMerck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake.
Drugmaker Merck & Co. says the Food and Drug Administration is reviewing the companys new drug application for suvorexant, its investigational insomnia medication.
Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep. If approved, Merck said suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep.
Suvorexant minimizes the morning grogginess common with many sleep aids, according to the Associated Press. In studies, the drugs most common side effects were tiredness and headache, the AP said.
"The discovery and development of innovative medicines that help patients is our goal at Merck, and insomnia is a common disorder where patients are seeking new treatments," said Darryle D. Schoepp, senior vice president and franchise head for neuroscience and ophthalmology at Merck Research Laboratories.
Suvorexant will be evaluated by the Controlled Substance staff of the FDA during review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.
Merck said it conducted two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.
Merck (NYSE: MRK), based in Whitehouse Station, N.J., said it continuing with plans to seek approval for suvorexant in other countries.
Posted by Phillipa on November 12, 2012, at 22:46:17
In reply to FDA is reviewing Merck insomnia drug, posted by herpills on November 12, 2012, at 21:48:58
Is it controlled? New Class? Thanks haven't heard of this. Phillipa
Posted by Phillipa on November 12, 2012, at 22:50:59
In reply to FDA is reviewing Merck insomnia drug, posted by herpills on November 12, 2012, at 21:48:58
Herpills here's another all over the web. Phillipa
http://www.examiner.com/article/sleep-longer-with-suvorexant
Posted by SLS on November 13, 2012, at 6:50:00
In reply to FDA is reviewing Merck insomnia drug, posted by herpills on November 12, 2012, at 21:48:58
> New York Business Journal
> Date: Thursday, November 8, 2012, 2:44pm EST
>
>
>
> Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake.
This is great. Suvorexant would work in a way that is opposite to Provigil and Nuvigil.Thanks for posting this.
- Scott
Posted by Hugh on November 13, 2012, at 11:34:35
In reply to FDA is reviewing Merck insomnia drug, posted by herpills on November 12, 2012, at 21:48:58
This is exciting news. An insomnia drug with a completely new mechanism of action. The old standards, benzodiazepines and other drugs that target the GABA-A receptor, such as Ambien, are not good for sleep architecture, and frequently cause tolerance and withdrawal symptoms.
Posted by ChicagoKat on November 13, 2012, at 16:33:55
In reply to FDA is reviewing Merck insomnia drug, posted by herpills on November 12, 2012, at 21:48:58
great! when can i get some? :P
Kat
Posted by jono_in_adelaide on November 14, 2012, at 2:45:29
In reply to Re: FDA is reviewing Merck insomnia drug » herpills, posted by ChicagoKat on November 13, 2012, at 16:33:55
I dont want this new stuff, bring back Mandrax I say!!!
Posted by Phil on November 14, 2012, at 11:33:36
In reply to Re: Bring back Mandrax!, posted by jono_in_adelaide on November 14, 2012, at 2:45:29
We could always tell when our friends were out of Mandy's because none of us had new dents in our cars. And we weren't sex machines anymore. Good stuff. I stole my mothers quaaludes when I found them in a bathroom drawer. I whittled them away. :)
I wasn't officially on psych meds yet. I was on fun meds.
Posted by Hugh on November 14, 2012, at 14:49:02
In reply to Re: FDA is reviewing Merck insomnia drug » herpills, posted by ChicagoKat on November 13, 2012, at 16:33:55
> great! when can i get some? :P
> KatIf all goes as planned, it should be available by early 2014.
Posted by ChicagoKat on November 14, 2012, at 17:10:21
In reply to Re: FDA is reviewing Merck insomnia drug » ChicagoKat, posted by Hugh on November 14, 2012, at 14:49:02
> > great! when can i get some? :P
> > Kat
>
> If all goes as planned, it should be available by early 2014.OK, I'll stay awake til 2014. Then I'll sleep for a year to make up for lost time. Thanks so much for the info; it gives me hope.
Kat
>
>
Posted by jono_in_adelaide on November 15, 2012, at 18:30:37
In reply to Re: FDA is reviewing Merck insomnia drug » Hugh, posted by ChicagoKat on November 14, 2012, at 17:10:21
Until this comes along, rotating sleep meds might be an useful option, taking a benzo or a z drug for 2 nights, then a drug that works on the histamine/5HT2 system for 2 nights (seroquel, doxepin, benadryl, etc) to prevent tolorance building up.
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