FDA panel recommends Merck’s insomnia drug for approval

An FDA advisory panel has voted in favour of Merck & Co's experimental insomnia drug, saying that it is safe and effective for elderly patients at the lower of two doses studied. While the FDA doesn't have to follow its committee's decision when it comes to approving the drug, it usually does.

The Peripheral and Central Nervous System Drugs Advisory Committee meeting voted 13 – 3, with one abstention, that suvorexant is safe for elderly patients at 15 milligrams a day and for non-elderly adults at 20 milligrams. The panel also voted 8-7, with two abstentions, that the drug is not safe at 30 and 40 milligrams.

If approved, Merck & Co's (known as MSD outside the US and Canada) suvorexant would be the first in a class of sedatives, called orexin receptor antagonists, designed to help people with insomnia fall asleep and stay asleep.

"We are excited about the potential of suvorexant as a new and different approach to treating insomnia, a serious condition that affects up to one-third of the adult population. Today's votes and discussion bring us one step closer to providing physicians with another option to help patients struggling with insomnia. We look forward to working with the FDA as the agency continues its review of our application."

Darryle Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories.

There were some concerns ahead of the advisory meeting after FDA's internal reviewers published a report expressing the drug's potential to cause next-day sleepiness and impaired driving. However, the panel's vote shows it determined that the drug does work at its proposed dose levels.

The FDA will now consider the Committee's recommendations as it completes its review of the NDA for suvorexant. Merck & Co anticipates FDA action in mid-2013.