24 May 2013, BioSpectrum Bureau , BioSpectrum
Singapore: An US FDA panel has voted that Merck & Co experimental insomnia drug appears to be safe and effective, despite evidence from company trials that the pill can cause daytime sleepiness and difficulty driving. The FDA is not obligated to follow the recommendations of its experts, although it often does so.
A majority of US FDA voted Merck's sleeping aid, suvorexant, helped patients get to sleep and stay asleep. In a separate set of votes, the panel voted that the drug appears safe at the starting doses proposed by the company. The panel opinion was somewhat at odds with the agency's own scientists, who issued a negative review of the drug. FDA staff pointed out that suvorexant was associated with daytime drowsiness, driving difficulties and suicidal thinking in trials conducted by Merck.
Dr Ronald Farkas, who presented the FDA's findings, said that, "How much is it worth to try and make the drug safer? How many people are you willing to risk versus how much effort are you willing to make?"
Although a majority of panelists endorsed the safety of initial doses proposed by Merck, which is 15 milligrams or 20 milligrams a day for elderly patients or non-elderly patients. However, the FDA had suggested that a lower dose of 10 milligrams might be safer for patients than the higher doses proposed by Merck.
Merck has suggested raising patients' prescriptions to the higher levels if they do not respond to lower doses. A Merck spokeswoman said Wednesday the FDA is expected to issue a decision on suvorexant by mid-year. If approved the drug will have to be scheduled as a controlled substance by the Drug Enforcement Administration.