FDA panel says Merck’s sleep drug safe, effective at lower dose

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WASHINGTON (Reuters) – Merck & Co’s experimental insomnia drug was safe and effective at the lower of two doses studied, a panel of medical experts said on Wednesday, increasing the chance it will be approved by the U.S. Food and Drug Administration.

The advisory panel was convened to help the FDA decide whether to approve the drug, suvorexant, which would be the first in a new class of sedatives designed to help people fall asleep and stay asleep.

On Monday, the FDA’s internal reviewers published a report expressing concern about the drug’s potential to cause next-day sleepiness and impaired driving. They asked the committee to consider whether patients should be started at a lower dose than that recommended by Merck.

Merck proposed that elderly patients start by taking 15 milligrams of the drug and increase that to 30 if necessary. The company recommended non-elderly adults start on 20 milligrams and increase it to 40 milligrams if needed.

On Wednesday, the FDA reiterated its opinion that there was little evidence in Merck’s data to show that the higher dose was more effective than the lower dose, and considerable evidence to show it was less safe.

The FDA’s reviewers pointed to an increase in the risk of suicidal thoughts and behaviors, an increased risk of impaired driving, and an increased risk of severe sleep disturbances.

Speaking for the FDA, Dr. Ronald Farkas noted cases in which patients had reported sleep paralysis and terrifying hallucinations. He also expressed the agency’s concern about the drug’s impact on driving.

“What we are trying to prevent is criminal prosecution of patients taking their drug as prescribed,” he said.

Merck celebrated the panel’s recommendation, saying in a statement that it was “excited about the potential of suvorexant as a new and different approach to treating insomnia.”

The FDA is not bound to follow the advice of its advisory panels but typically does so.

The FDA had asked the panel to consider whether patients should start with a 10 milligram dose, saying data from a smaller trial showed that amount might work for some people. Merck disputed that, saying 10 milligrams would not be effective.

The FDA asked the panel if Merck should conduct an additional trial to further evaluate a 10 milligram dose. The panel voted against that. Some panelists agreed with Merck that 10 milligrams would not be effective. Others agreed in principal with a lower starting dose, but said a new trial would not add meaningfully to the information already in hand.

The panel voted 13-3, with one abstention, that the drug is safe for elderly patients at 15 milligrams a day and for non-elderly adults at 20 milligrams. It voted 8-7, with two abstentions, that the drug is not safe at 30 and 40 milligrams.

(Reporting by Toni Clarke in Washington- Editing by Alden Bentley and Leslie Adler)

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