Vanda sleep drug effective in second late-stage trial
Wed Jan 23, 2013 7:49am EST
(Reuters) - Vanda Pharmaceuticals Inc said its experimental drug for a rare sleep disorder proved effective in a second late-stage trial, and the company now plans to apply for a U.S. approval for the drug in mid-2013.
The study, named Reset, was a 20-patient trial designed to test the maintenance effect of a 20 mg dose of the drug, tasimelteon.
Vanda on December 18 said the drug performed better than a placebo in the first of the four planned late-stage trials on the drug. The company's shares rose as much as 37 percent on that day.
While the first two are efficacy studies, the remaining two are intended to establish the safety profile of the drug.