FDA Recommends Approval of Sleep Disorder Drug Tasimelteon


tasimelteonIn mid-November 2013 the FDA announced their recommendation for the approval of Tasimelteon for the treatment of non-24-disorder. This rare condition, which primarily affects the blind, occurs when the body’s biological clock does not work properly. Patients who are blind and experience this frustrating type of insomnia can now find relief, as Tasimelteon effectively resets the circadian rhythm, helping to restore normal sleep patterns.

Marketed by VANDA Pharmaceuticals under the brand name HETLIOZ, Tasimelteon is unique in that it does not lead to dependence. Unlike typical benzodiazepines such as Zolpidem {Ambien}, Tasimelteon has no affinity for the GABA receptor in the brain. This makes the likelihood for dependency or abuse of this drug nonexistent.

Results from a phase 3 trial of Tasimelteon showed significant success for the treatment of non-24 disorder in blind patients. Participants in the phase 3 study documented considerable improvements in the quality of their nighttime sleep. In addition, patients who received Tasimelteon reported a great reduction in daytime sleepiness. Results from the phase 3 study were presented at the Endocrine Society’s 95th Annual Meeting, coined ENDO 2013.

Tasimelteon is particularly efficacious for the treatment of this disabling sleep disorder that affects the blind, as their typical circadian clock, which is regulated by the daylight and darkness cycle is pointedly disturbed. Tasimelteon is an effectual melatonin agonist, and it targets the same receptors as melatonin. Statistical results from the SET study {Safety and Efficacy of Tasimelteon} showed that 20 percent of blind patients who had received Tasimelteon were able to reset their circadian clock, as compared to only 3 percent of patients in the placebo group.

The use of this formidable new treatment is an exciting option for patients who do not wish to be prescribed hypnotic or addictive medications to treat their sleep disorder. LGM Pharma provides Tasimelteon API, CAS# 609799-22-6, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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