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he considers the drug an intriguing option for patients.
“If one looks at the control of sleep,” Roth says, “there are transmitters to drive sleep (EG GABA) and there are transmitters which drive wakefulness like histamine, orexin, and seratonin. Antagonists to these systems produce sleep. However, this is different than working on sleep systems. For example, if you look at Silenor, there is data to show that it improves sleep in the last two hours of the night without impairing alertness the next days. Drugs working on Gaba do not have that combination. I think this medication will benefit patients who have difficulty with staying asleep during the night.”
Still, Roth was careful to point out that he hasn’t reviewed the whole drug application like the FDA has.
As a reminder, here’s some of the quick facts on the Silenor application. The company hopes to compete a crowded marketplace with brands like Sanofi-Aventis’ zolpidem (Ambien and Ambien CR), King Pharmaceuticals’ zaleplon (Sonata), Dainippon Sumitomo’s eszopiclone (Lunesta), and Takeda Pharmaceuticals’ ramelteon (Rozerem).
Somaxon says its drug is different from the others, in that it is designed to block histamine, a neurotransmitter in the brain that’s believed to help keep people awake. Clinical trials to date have shown that the drug can help people get a full night’s sleep including sleep into the 7th and 8th hour, the company says.
The FDA, back in February 2009, told Somaxon there didn’t appear to be any adverse events that would stand in the way of the drug getting approved. But the agency did question how the company interpreted data on the drug’s effectiveness.
In April, the FDA told Somaxon that if it were going to get the green light for an insomnia drug—which could be used chronically by millions of people without a life-threatening condition—-then “objective and subjective efficacy must be established in both adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined to be at least one month,” the company said in its quarterly report.
Somaxon went back to re-analyze some of its clinical trials, to respond to the FDA’s input. Whether this passes muster with the FDA, we’ll find out soon. Maybe Friday. Maybe Monday.