Vanda reports more Phase III sleep disorder data

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) said once-daily oral tasimelteon met the primary endpoint in the Phase III RESET trial to treat non-24-hour sleep wake disorder. In patients who responded to tasimelteon in the three-month run-in portion of the trial, a greater proportion of patients who continued treatment with tasimelteon for an additional two months maintained circadian rhythm entrainment to the 24-hour day vs. those who switched treatment to placebo (90% vs. 20%, p=0.0026). The trial enrolled 20 blind patients without light perception and a body clock period of more than 24 hours.

Vanda said it still plans to submit an NDA to FDA in mid-2013 for tasimelteon to treat non-24-hour sleep wake disorder. In December, the company reported that in the 84-patient Phase III SET trial, tasimelteon for six months met the co-primary endpoints of a greater proportion of patients achieving entrainment of the endogenous circadian melatonin rhythm to the 24-hour clock and of improving clinical response rate at six months vs. placebo. Top-line data from the Phase IIb/III MAGELLAN trial of tasimelteon to treat major depressive disorder (MDD) are expected this quarter. In 2004, Bristol-Myers Squibb Co. (NYSE:BMY) granted Vanda exclusive, worldwide rights to tasimelteon, a melatonin MT1 and MT2 receptor agonist. ...