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Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression
Date:3/31/2011

sored by the National Institute of Mental Health, it was shown that two thirds of patients continued to exhibit symptoms even after a course with currently available treatments (2).  In addition to this partial response to treatment, patients often experience a number of significant side effects including sexual dysfunction, insomnia and weight gain.

If successful, tasimelteon could add significant value to the treatment armamentarium for depression.  Its novel mechanism of action as a circadian regulator could address both the mood as well as the sleep disruption in patients with MDD, and at the same time offer a mild side effect profile.

The Vanda Phase IIb/III trial will investigate the efficacy and safety of tasimelteon versus placebo in the treatment of MDD. The study is expected to include an 8-week treatment period and an optional open-label extension. Vanda plans to assess the antidepressant and circadian effects of tasimelteon, as well as further characterize the safety profile of the compound.  

Tasimelteon and the Body Clock

Tasimelteon is a circadian regulator that binds to two high-affinity melatonin receptors, Mel1a (MT1R) and Mel1b (MT2R).  These receptors are found in high density in the suprachiasmatic nucleus of the brain (SCN), which is responsible for synchronizing an individual's sleep/wake cycle.  Tasimelteon is currently being evaluated for the treatment of N24HSWD, which is a chronic circadian rhythm sleep disorder (CRSD) that occurs when an individual is unable to synchronize their internal clock to the 24-hour light/dark cycle.  Tasimelteon may also have applications in other CRSDs, including Delayed Sleep Phase Disorder, Jet Lag and Shift Worker Sleep Disorder.  

References

1. Hum Psychopharmacol. 2008 October; 23(7): 571–585

2. National Institutes of Mental Health:

SOURCE Vanda Pharmaceuticals Inc.
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