Check out what the FDA and numerous news outlets are reporting about Suvorexant.....
Suvorexant FDA Review
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The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug's effectiveness was consistent across several doses tested by Merck & Co. Inc.
But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness.
The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking or behavior reported among patients taking the drug, compared with no cases among patients given placebo.
But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness.
The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking or behavior reported among patients taking the drug, compared with no cases among patients given placebo.
Let s see what comes out of the FDA meeting Wednesday. Then we'll know if u are right.
First Suggamadex now Suvorexant. Who is taking accountability for this?
This drug will be faced by Ambien, which is very good and well entrenched. It's also a generic.
Good luck with your sleep med. If it even gets approved, it's a dog in the making. Dulera All Over Again should be the brand name.
Good luck with your sleep med. If it even gets approved, it's a dog in the making. Dulera All Over Again should be the brand name.
No one with a brain would initiate a neuro team - look at the OVERWHELMIMG success of the first one. Could you see the abberant circuitry of such a business undertaking?
These post show how bad the information is here. We have a neuro team right now you dumb assess. What is the talk of creating one or re-creating one. They sell Saphris and are picking up this sleep aid when approved. Wow if this doesnt show you what this site is worth nothing will.
I'll second that. There's what is really going on at Merck and then there's what CP would lead one to believe is going on at Merck.
HSCs have been working with this since late last year and Neuro reps to promote to specialists. Our DCO said one PCP group would get this drug. What group will promote it? Told it would happen 4q. Hope I get to sell it. Whichever group gets sleep is safe from the planned salesforce reduction in upcoming months.
-You just made my point - what has the current "team" accomplished - nothing
post 2 was word for word from the FDA. What are you writing about? Get your fact straight A-HOLE.
Even if it is approved it has to go to the DEA for classification which could take 3-4 months
HSCs have been working with this since late last year and Neuro reps to promote to specialists. Our DCO said one PCP group would get this drug. What group will promote it? Told it would happen 4q. Hope I get to sell it. Whichever group gets sleep is safe from the planned salesforce reduction in upcoming months.
Can today's news possibly get any worse.....Feel bad for those who had worked on this for the last year and a half. Hopefully they were wise enough to have their plan B escape plan ready.
To me this looks like good news. 10mg dose does not need further studies, just a manufacturing review. See no further problems for approval.
A flury of activity today. Things are going down, real time. Fasten your seatbelts.