Vanda Pharmaceuticals Inc released results of a second Phase III study of tasimelteon, which demonstrated positive results for the treatment of Non-24-Hour Disorder.
The study examined the effects of randomized withdrawal of the drug on 20 patients suffering from Non-24, a rare circadian rhythm disorder that affects as many as 95,000 totally blind individuals whose internal “body clocks” cannot maintain the 24-hour day.
Results found that tasimelteon-treated patients maintained their clinical benefits while placebo-treated patients showed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep, according to Vanda.
“These results clearly demonstrate that tasimelteon can entrain the circadian clock and continued treatment is necessary to maintain entrainment,” said Steven W. Lockley, PhD, of the Division of Sleep Medicine at Brigham and Women’s Hospital. “The study also shows that entrainment is associated with meaningful clinical benefits and that maintaining entrainment of the master body clock is critical to treating the problems caused by Non-24.”
Vanda says the results are significant because presently there is no approved treatment for Non-24.
“We are excited by these results as they move us one step closer toward providing a treatment for blind individuals with Non-24,” said Vanda president and CEO Mihael H. Polymeropoulos, MD. “We are confident that if approved, tasimelteon may significantly improve the quality of life for individuals with Non-24.”
Tasimelteon is currently designated as an orphan drug by the United States and European Union, according to Vanda. The company said it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration in mid-2013.
