US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses

The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday voted 13 to three to approve drug giant Merck & Co’s (NYSE: MRK) investigational insomnia medicine suvorexant at doses of 15mg and 20mg, but voted eight to seven (with one abstention) against the 30mg and 40mg doses, saying that these were not safe.

“There is no evidence the higher doses are more effective but there is more evidence they’re more dangerous,” Jason Todd, a panel member and neurologist at NorthEast Neurology in Concord, North Carolina, said during the meeting, quoted by Bloomberg. The advisory panel still determined that the drug does work at all the doses proposed. The panel voted 12 to four that suvorexant helps people fall asleep and unanimously that the drug helps people stay asleep.

Darryle Schoepp, senior vice president and head of neuroscience and ophthalmology, at Merck Research Laboratories, commented: “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.”