The U.S. Food and Drug Administration advisory committee has Wednesday found clear evidence that healthcare giant Merck & Co., Inc.'s (MRK) blockbuster drug candidate suvorexant is quite effective in promoting sleep, but multiple safety issues call for lower doses.
The FDA's peripheral and central nervous system advisory committee reportedly agreed that the drug was generally safe and effective for treating sleep maintenance and latency. The panel voted 13-3, recommending lower starting doses of 15 mg for elderly and 20 mg for non-elderly.
The panel delivered a split recommendation, seven for and eight against, on the safety of the higher doses of the product. The safety issues from higher doses could seriously hamper Merck's attempt to market the new drug.
"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," said Darryle Schoepp, senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories.
Suvorexant, a orexin receptor antagonist, will be a new class of insomnia drugs that works by blocking brain chemicals that keep people awake. It is indicated for patients with insomnia, a condition characterized by difficulty falling asleep and/or staying asleep. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep.
Insomnia is a serious condition characterized by difficulties with sleep onset and/or maintenance that affects up to one-third of the adult population. Despite the availability of a number of medical treatments, it remains a significant medical problem. Persistent insomnia impacts patients directly through psychiatric and broader health-related risks, as well as society more generally through occupational, public safety, and economic aspects.
The world's second-biggest drugmaker said it anticipates FDA action on suvorexant over the next two months. The FDA will consider the panels recommendations and will take its advice into consideration, but is not bound by the panel's recommendations. However, it usually does.
The New Drug Application or NDA, for suvorexant was accepted in November 2012 for standard review by the U.S. FDA. The NDA was submitted by Merck Sharp & Dohme Corp. or MSD, as Merck is known outside the U.S. and Canada.
The company is continuing with plans to seek approval for suvorexant in other countries around the world.
MRK closed Wednesday's regular trading session at $46.71, down $0.62 or 1.31% on a volume of 42.63 million shares.
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