Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ™ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ™ is the first FDA approved medication for Non-24.
Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.
"The FDA approval of HETLIOZ™ would not have been accomplished without the heroic efforts of blind patients and their advocates," said Mihael H. Polymeropoulos, M.D., Vanda's President and Chief Executive Officer. "We are committed to providing much needed support to patients with Non-24 and facilitating access to this new therapeutic option."
The approval of HETLIOZ™ was based on two key efficacy studies and the safety has been evaluated in over 1,300 individuals.
The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection. After taking HETLIOZ™, patients should limit their activity to preparing for going to bed because HETLIOZ™ can impair the performance of activities requiring complete mental alertness.
"Totally blind people have struggled with the problems brought on by Non-24-Hour Sleep-Wake Disorder, sometimes for their entire life, without understanding what causes it and without being able to do anything about it," said Steven W. Lockley, Ph.D., Division of Sleep Medicine, Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School. "Today's FDA approval of HETLIOZ™ means that, for the first time, these patients have access to an approved, safe and effective treatment for their difficult debilitating disorder."
Vanda anticipates making HETLIOZ™ commercially available in the second quarter of 2014.
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