Vanda Pharmaceuticals has been boosted by the publication of data which suggest that the firm’s experimental insomnia drug tasimelteon could play an important role in regulating sleep for jet-lag sufferers and shift workers.
Results from two clinical trials have been published in The Lancet which demonstrate the sleep-promoting effects of tasimelteon, also known as VEC-162, a novel circadian regulator that acts by resetting the body clock. The research, led by Shantha Rajaratnam of Brigham and Women’s Hospital and Harvard Medical School, presented results from two clinical studies with more than 400 volunteers, who were asked to initiate sleep five hours before their usual bedtimes.
The authors said that tasimelteon “has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders”, including people affected by jet lag, or those who work at night, and early-riser workers. The Vanda drug mimics melatonin which regulates the sleep-wake cycle and is produced by the pineal gland.
Melatonin is sold as a supplement in the USA but such products are not regulated and there is a dearth of clinical data published to demonstrate a clear effect in treating jet lag and other sleep disorders. Also, tasimelteon seems to have a much better side effect profile than hypnotics such as Sanofi-Aventis’ Stilnox/Ambien (zolpidem) and Sepracor’s Lunesta (eszopiclone).
The market Vanda is targeting is a big one. These disorders represent a large public health problem, the company says, and a 2006 Institute of Medicine report noted that the annual economic impact of sleep problems due to night shift work alone is estimated to exceed $65 billion.
