FDA panel backs Vanda's circadian rhythm drug
An advisory panel to the Food and Drug Administration said on Thursday that an experimental drug designed to help regulate the internal body clocks of blind patients appears safe and effective.
The drug, tasimelteon, is designed to treat Non-24-Hour Sleep-Wake Disorder, or Non-24, a condition that is most commonly found in the totally blind and can cause disrupted nighttime sleep patterns and excessive daytime sleepiness.
If approved it would be marketed under the proposed brand name Hetlioz.
The FDA is due to make a decision on whether to approve the drug by January 31, 2014. The agency is not bound to follow the advice of its advisory panels but typically does so.
Non-24 is a rare disorder that affects between 65,000 and 95,000 people, according to Vanda. It occurs almost exclusively in people who are deprived of light, which is needed to synchronize the body's internal clock.
Tasimelteon affects melatonin, a hormone produced by the body's pineal gland that plays a key role in regulating the body's master circadian clock. When taken before bed it resets the circadian clock by replacing the normal resetting triggered by light.
In two clinical trials, Washington-based Vanda said the drug offered improvements to patients across a variety of sleep and wake parameters including measures of total sleep time and daytime nap duration.
The most common side effects included back pain, vivid dreams, diarrhea, dry mouth, headache, sleepiness and upper respiratory tract infections.
The drug has been given Orphan Drug status by the FDA. Orphan drugs are designed to treat diseases that affect fewer than 200,000 people. If approved, the drug would receive seven years of U.S. market exclusivity.
In January the company said tasimelteon failed to improve symptoms in a clinical trial of patients with major depressive disorder.