Tasimelteon, an investigational drug being tested by Vanda Pharmaceuticals Inc, could help totally blind people sleep better.
Vanda is now studying tasimelteont in totally blind people suffering from Non-24-Hour Sleep Wake Disorder (N24HSWD) on a Phase III clinical trial.
Non-24-Hour Sleep Wake Disorder (N24HSWD) leads to abnormal night sleep patterns and chronic daytime sleepiness. This disorder is commonly experienced primarily by totally blind individuals.
Tasimelteon has been shown affecting melatonin, a chemical substance in the brain which play crucial in maintaining sleep as it is thought to be regulating body’s own internal clock that is responsible for sleep/wake cycles or circadian rhythms.
Tasimelteon is an oral compound that bind selectively to melatonin receptors. Tasimelteon has been shown to improve sleep parameters in clinical studies that simulated a desynchronization of the circadian clock.
Tasimelteon is found binding to two high affinity melatonin receptors, Mel1a (MT1R) and Mel1b (MT2R) found in high density in the suprachiasmatic nucleus of the brain (SCN) which is responsible for synchronizing our sleep/wake cycle.
So far, tasimelteon has been studied in more than 900 individuals and has shown a good tolerability profile, according to a press release from Vanda.
Tasimelteon caused significant improvement in sleep onset and sleep maintenance without evidence of next-day residual effects, in two such studies.
“Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks. As a result, these individuals can live lives in a constant state of circadian misalignment. Tasimelteon has the potential to be the first in the class of circadian regulators, drugs that may offer clinical benefits to patients with aberrant timing of the sleep/wake cycle,” stated Mihael H. Polymeropoulos, M.D. President and Chief Executive Officer of Vanda.
US FDA granted orphan drug designation status for tasimelteon in Non-24-Hour Sleep/Wake Disorder in blind individuals without light perception.
In the phase 3 clinical trial, Vanda plans to investigate the efficacy and safety of 20 mg tasimelteon in totally blind individuals with N24HSWD in about 160 totally blind people for a 6-month treatment period and an optional open-label extension.
Vanda will report top-line results for the study in the fourth quarter of 2011.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company developing central nervous system therapies.