FDA Advisors: Experimental Merck Insomnia Drug Effective at Low Doses
Good news for all those reluctant night owls out there - the US Food and Drug Administration (FDA) advisory panel has approved an experimental insomnia drug made by Merck & Co's and deemed it safe and effective, increasing the chances it will be approved soon.
The advisory panel gathered to assist the FDA in deciding whether to approve the drug, suvorexan. In a separate set of votes, the panel voted that the drug appears safe at the starting doses proposed by the company. If approved, suvorexan will be the first in a new class of sedatives designed to help people fall asleep and stay asleep. However, the FDA is not required to follow the recommendations of its experts, although it often does.
Merck asked the FDA to allow the lowest dose of the new drug to be 15 mg, but FDA reviewers found little evidence to support higher doses of the drug were superior to 10 mg and 15 mg. Merck's suggestion was to start elderly patients at 15 mg of suvorexant and non-elderly patients at 20 mg. The 10-mg dose was only studied in a phase II trial, and not phase III -- but that fact may not stop the FDA from approving a 10-mg dose.
In a statement, Merck said, "today's votes and discussion bring us one step closer to providing physicians with another option to help patients struggling with insomnia."
The panel voted 13-to-3 in favor of the safety of two proposed starting doses of suvorexant. One person abstained from voting, according to the statement.
The FDA is expected to issue a decision on suvorexant by mid-year. If approved, however, the medicine would also need to go through a classification process at the Drug Enforcement Administration that is required for drugs with a potential for abuse.