Phase 3 results show promise for blind individuals with circadian rhythm disorder

Vanda Pharmaceuticals announced positive results from a phase 3 study evaluating tasimelteon, a circadian regulator for the treatment of non-24-hour disorder, a serious condition that affects a majority of totally blind individuals who lack light perception, according to a company press release.

These individuals, without perception of light, cannot reset their master body clock to the 24-hour day. There is currently no approved treatment for the disorder.

The study included 84 patients with the disorder and was randomized, double-masked and placebo-controlled, according to the release.

At completion of the phase 3 clinical trials, tasimelteon succeeded in the primary endpoint of entrainment (resetting) of the melatonin rhythm as compared to placebo.

Additionally, tasimelteon showed significant improvements across several sleep and wake parameters including measures of total sleep time, nap duration and timing of sleep.

“We are impressed and excited by the magnitude and robustness of the direct clinical benefits to patients,” Mihael H. Polymeropoulos, MD, president and CEO of Vanda, said in the release. “We believe that tasimelteon can be an effective and clinically meaningful treatment for patients suffering with this debilitating disorder.”