Merck: FDA wants more studies of insomnia drug

Drugmaker Merck & Co. says federal regulators have ruled that they won't approve high doses of its experimental insomnia medication because of concerns about their safety.

But Merck says the Food and Drug Administration has indicated it would approve lower doses of the drug, called suvorexant, after Merck provides additional data.

Merck spokesman Steve Cragle says the company is talking with the FDA to determine exactly what studies are needed.

However, the company says that at minimum it will have to do manufacturing studies on a low, 10-milligram dose, which the FDA wants to be the starting dose for most patients. That means Merck will have to repeatedly produce batches at that dose, which it hasn't done before, to show it can produce pills meeting strict specifications.

3.5 /5 (2 votes)
add to favorites email to friend print save as pdf

Related Stories

FDA has safety concerns on Merck insomnia drug

May 20, 2013

Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.

New sleeping pill poised to hit US markets

May 21, 2013

An experimental sleeping pill from US drug company Merck is effective at helping people fall and stay asleep, according to reviewers at the US Food and Drug Administration, which could soon approve the new drug.

Merck says FDA reviewing its ragweed allergy therapy

May 08, 2013

Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, ...

Recommended for you

Drug research and development more efficient than expected

Feb 27, 2015

Drug R&D costs have increased substantially in recent decades, while the number of new drugs has remained fairly constant, leading to concerns about the sustainability of drug R&D and question about the factors that could ...

Use new meningitis vaccines only for outbreaks

Feb 26, 2015

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

Feb 26, 2015

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

Tagging drugs to fight counterfeit medicines

Feb 25, 2015

The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.