Merck's Suvorexant Meets Phase III Study Goals; Still On Track For 2012 NDA

My buddy Ed Silverman, over at Pharmalot.com, just mentioned a bit of good news out of Whitehouse Station. And MRK is rising on the NYSE this morning (about 1.2 percent) on the news, in a generally-down market.

One of Merck's longest-running drug candidate development marches is nearing the finish line. Well, the finish line for development -- and thus, the starting line for commercial sales in the US.

The candidate, Suvorexant (no branded name has been announced by Merck, yet), appears to be a drug that improves sleep by dampening orexin receptors, thus by reducing alertness -- rather than "pushing up" sleepiness, as the older (now generic) GABA receptor-supressants do. [See my latest Suvorexant February 2012 backgrounder, here.]

Here is Bloomberg's piece, on the topic, this morning -- but this is good news:

. . . .The drug may be beneficial in patients with addiction problems on current sleep drugs, or who suffer from sleep apnea, where the body briefly stops breathing, Roth said. Current sleep therapies can suppress respiration. Clinicians are also looking for therapies that let patients wake easier and don’t cause dizziness and falls, he said.

“We want drugs that not only improve sleep but the comorbid conditions associated with sleep” problems, Roth said. “We think that it has potential.”

More study of the medicines must be done before those sorts of benefits over existing drugs can be proven, he said.

Merck will also have to gain approval from the Drug Enforcement Agency, because the pill is classified as a controlled substance. That will take another six to nine months after the FDA rules, according to the company.

Ambien and Lunesta, the current best-selling insomnia medications according to data compiled by Bloomberg, essentially subdue GABA receptors, which are spread throughout the central nervous system, putting people to sleep and acting as a muscle relaxant, anxiety reducer and anti-convulsant. Merck’s drug works by suppressing orexin receptors, which are only found in the hypothalamus region of the brain, according to Merck. The orexin receptors control wakefulness. . . .

The field is crowded with generics, but if Suvorexant can improve the wake-up experience (less day-time drowsiness), while still improving sleep-time at night -- it will be a significant advance, and could command both a premium price, and a very sizeable chunk of the US market share. We shall see -- it won't reach market now, until close to mid 2013, though (after DEA clearance).