non 24Vanda Pharmaceuticals new drug for non-24-hour sleep-wake disorder showed positive results in a late-stage study.

Non-24-hour sleep-wake disorder, also known as N24HSWD, is a chronic and little-known sleep dysfunction, mostly observed in blind people. The disorder results in symptoms of insomnia and/or excessive sleepiness. Currently there is no approved treatment for the disorder.

The drug– called tasimelteon, a circadian regulator, showed significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep.

The late-stage study, called SET study, had enrolled 84 patients with N24HD and had a six-month treatment period with tasimelteon. The trial was designed to evaluate both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle.

“Results confirm tasimelteon as a strong circadian regulator capable of entraining the master body clock in patients with Non-24. We are particularly impressed and excited by the magnitude and robustness of the direct clinical benefits to patients,” said Chief Executive Mihael Polymeropoulos.

Vanda Pharmaceuticals is also conducting another late stage trial of tasimelteon, called RESET trial. The trial is a 12-week, withdrawal study of 20 patients with N24HD to examine the maintenance effect of tasimelteon in the treatment of N24HD. The RESET study results are expected in the first quarter of 2013.

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