Merck preps FDA app after racking up positive PhIIIs on new sleep drug

Merck ($MRK) unveiled a full slate of Phase III data on its experimental sleep drug suvorexant, claiming a success in safely promoting a good night's rest among patients suffering from insomnia. And the pharma giant's team leader on the project says the late-stage results pave the way for an NDA later this year on one of the biggest late-stage drug prospects in its pipeline.

If you add up all the measures tracked on going to sleep faster and staying asleep, investigators tracked 30 different endpoints in both clinical studies, Darryle D. Schoepp, Ph.D., senior vice president and head of the Neuroscience and Ophthalmology franchise at Merck Research Laboratories, tells FierceBiotech. The drug cleared the statistical bar on 15 of 16 primary endpoints--missing one measure on promoting continuous sleep faster than a placebo after three months of treatment.

There's also a full set of safety data and a clear signal that 90% of patients didn't report feeling sleepy the day after they took the treatment, he adds, "which is remarkable."

This new class of drug, Schoepp says, targets wakefulness. To get to sleep you need to not be awake, and blocking orexins is a new path to achieve that. There's ample late-stage data to show that suvorexant works well and can be taken over long periods to promote a solid night's sleep, he says. The GABA drugs on the market now are taken as needed.

New sleep drugs, though, face some tough odds once they get to a very crowded market. Analysts have noted that Americans are spending less on sleep drugs as mainstays like Ambien lose patent protection. But Merck is counting on an large set of data to convince millions of people with insomnia to check out a new approach. Analysts, though, have been cautious when it comes to estimating peak sales for sleep therapies.

"The potential for a new and different option would be welcome by patients with insomnia who cannot sleep through the night," said Andrew D. Krystal, M.D., a professor of psychiatry and behavioral sciences at Duke University Medical Center. 

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