Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals' Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
ROCKVILLE, Md., Dec. 1 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) reports publication in The Lancet, one of the world's leading medical journals, results of clinical trials of its novel circadian regulator, experimental compound tasimelteon (VEC-162). The publication by Rajaratnam et al(1) is entitled "Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials." Results are reported from two clinical trials that demonstrate the sleep-promoting effects of tasimelteon, a novel circadian regulator that acts by resetting the body clock. The internal body clock is a complex molecular machinery that governs the rhythm of many body functions, the most well described of which is the sleep-wake cycle.
In the same issue of The Lancet, in an accompanying editorial, "Let there be sleep -- on time," Cardinali and Golombek(2) discuss the implications of the circadian regulatory and sleep-promoting effects of tasimelteon. They also point to the need for public health education and a move towards more effective agents that do not present the safety issues encountered with current sleep treatments.
The article by Rajaratnam et al(1) presents results from two clinical studies with more than 400 volunteers, who were asked to initiate sleep five hours before their usual bedtimes. Tasimelteon was shown to reset the molecular machinery of the circadian clock and restore the sleep-wake cycle by improving both the ability to initiate and to maintain sleep as compared to placebo-treated patients.
The body's circadian clock plays significant roles in regulating sleep, mood as well as cardiovascular and metabolic processes.(3)(4) Circadian rhythm sleep disorders include insomnia associated with shift work (overnight, rotating and early riser), travel across time zones, delayed sleep phase syndrome, advanced phase syndrome and the non-24-hour sleep-wake syndrome in the blind. These disorders represent a large public health problem and, as presented in the 2006 Institute of Medicine (IOM) report on sleep disorders(5), the annual economic impact of sleep problems due to night shift work alone is estimated to exceed $65 billion.
The novel circadian regulator tasimelteon holds promise for the treatment of patients with misalignments of the body clock. The work presented in The Lancet examines the potential application in sleep disorders. Additional clinical trials will have to be conducted to examine the role of circadian regulators in the treatment of other disorders such as depression, nondipper hypertension(3)(4), and others.
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(1) Rajaratnam, Shantha M.W.; et al. "Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomized controlled multicentre trials." www.thelancet.com. 2008.
(2) Cardinali, Daniel P.; Golombek, Diego A. "Let There Be Sleep - On Time." Letter. www.thelancet.com. 1 December 2008.
(3) Bunney, Jennifer N.; Potkin, Steven G. "Circadian abnormalities, molecular clock genes and chronobiological treatments in depression." British Medical Bulletin. 2008; 86 (1): 23-32.
(4) Perez-Lloret, Santiago; Garcia Aguirre, Alejandro; Cardinali, Daniel P.; Toblli, Jorge E. "Disruption of Ultradian and Circadian Rhythms of Blood Pressure in Nondipper Hypertensive Patients." Hypertension. 2004; 44: 311-315.
(5) Colten, Harvey R.; Altevogt, Bruce M. Institute on Medicine. Committee on Sleep Medicine and Research. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. 2006.