Merck Sleep Drug Hits Trial Goals, Raising Hopes for New Blockbuster

6/13/12Follow @arleneweintraub

At the annual meeting of the Associated Professional Sleep Societies in Boston today, drug giant Merck (NYSE: MRK) released promising data from two late-stage human trials of its experimental insomnia drug, suvorexant. The compound—which promotes sleep through an entirely different pathway in the brain than those targeted by the drugs on the market today—achieved 15 out of 16 of the main endpoints the company had set out to study in the trials. Merck intends to file for FDA approval of suvorexant by the end of this year, says Darryle Schoepp, senior vice president and franchise head of neuroscience and ophthalmology for Merck, which is based in Whitehouse Station, NJ.

In the two trials, which involved more than 2,000 insomniacs in total, suvorexant reduced both the amount of time it took for patients to fall asleep and the middle-of-the-night awakenings, when compared to placebo. All in all, patients on the drug gained about an hour’s worth of extra sleep per night during the three-month study period. The most common side effect of the drug, Merck reports, was next-day drowsiness, though Schoepp points out that it only occurred in about 10 percent of trial participants, even in the year-long safety study that the company performed. “In a one-year study, they had 365 opportunities to say they were sleepy the next day, but 90 percent of patients never reported that,” he says.

Suvorexant is the first of an emerging class of drugs that block orexins—chemical messengers in the brain that direct the transition from slumber to wakefulness. That’s what distinguishes it from most prescription sleep drugs, such as Sanofi’s (NYSE: SNY) blockbuster zolpidem (Ambien). Those drugs enhance the activity of GABA, a different brain chemical that slows down the firing of neurons in the brain, thereby promoting sleepiness. “Essentially they depress the nervous system,” Schoepp says of the current class of insomnia remedies.

Orexin is not nearly as ubiquitous in the brain as GABA is, Schoepp adds, making Merck’s approach to sleep more targeted than that of currently marketed insomnia treatments. “You have billions of neurons in your brain, and GABA is present in about half of them,” he says. “But there are only about 100,000 neurons with orexin. They are a small group, but they’re quite important because they tell your brain to transition into sleep.”

If Merck’s drug is approved, it could grab a large share of one of the richest corners of the pharmaceutical market. Sales of prescription sleep aids totaled $1.8 billion last year, according to healthcare services and information provider IMS Health. That number has actually been declining of late, because of the rise of generic zolpidem, which hit the market in 2007. Any company that succeeds in rolling out a novel entry could push the market back to pre-2007 levels, when sales of sleep drugs exceeded $3.5 billion, according to IMS. And Merck could use a hit drug to make up for declining sales of its $5-billion-a-year asthma drug montelukast (Singulair), which will lose its patent protection and face generic competition in August.

That said, novelty in the sleep market begets uncertainty, so the FDA has required Merck to carry out exceptionally large, lengthy, and wide-ranging studies to prove that suvorexant is safe. It’s no wonder: The drug was making its way through early development at about the time the FDA was receiving bizarre reports … Next Page »

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