Vanda Pharmaceuticals Inc. announced Friday that the FDA (Food and Drug Administration) has just approved a new treatment for blind people who have problems sleeping. Specifically Hetlioz, the melatonin receptor agonist tasimelteon, has been Okayed to treat “non-24-hour sleep-wake disorder” for totally blind patients. Dr. Steven Lockley of Brigham and Women’s Hospital in Boston stated that a lot of blind patients with “non-24″ are typically diagnosed with narcolepsy or insomnia. (It is called “Non-24” because it is a sleep disorder rooted in a completely blind person’s inability to regulate his/her body clock by identifying daylight from darkness.)
Dr. Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, added that “Non-24- hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted. Hetlioz can improve the ability to sleep at night and to be active during the day.”
This official approval came following the successful completion of two clinical trials. The trials included 104 patients. Results indicated that the new drug substantially “improved circadian rhythms” when compared to a placebo. The complete findings were initially reported at the American Association of Clinical Endocrinology meeting in San Francisco, California last June.
There is presently no other treatment for this condition. FDA estimates indicate there there are approximately 100,000 patients in the United States who cannot perceive light enough to allow them to form a normal sleep schedule. Vanda hopes to be producing Hetlioz and making it commercially available later this year. According to reports, the most common side effects of the drug may include disturbed sleep, drowsiness, elevated liver enzymes, headache, nightmares or unusual dreams, upper respiratory and urinary tract infection.
(Image courtesy of TNAE)