Vanda Pharmaceuticals’ recent announcement that it is one step closer to commercializing a new insomnia medication may be good news for some sleep disorder patients who are currently going untreated. The Rockville-based firm announced Wednesday the completion of its first round of Phase III clinical trials for the drug VEC-162. Vanda, which went public in April, hopes to have the drug on the market in 2009.
“VEC-162 may be an effective new treatment for sleep disorders in general and also may be able to treat an important subset of sleep disorder patients for whom there is currently no available, effective drug treatment,” said Mihael Polymeropoulos, president and CEO of Vanda, in a statement.
The drug is specifically being tested for sleep disorders involving circadian rhythms. Circadian rhythm sleep disorders occur when a person’s internal sleep/wake cycle does not match his or her desired sleep time. Jet lag and sleep difficulties caused by abnormal work hours are both circadian rhythm sleep disorders. Vanda is also looking into the possibility the drug may treat some forms of depression. The drug, which may eventually compete with such sleep disorder medications as Rozerem and Ambien, is expected to enter into a second round of Phase III trials this year and seek approval from the Food and Drug Administration sometime in 2008.
With more than 70 million Americans suffering from sleep disorders, the market potential is substantial. Last year, worldwide sales of insomnia drugs totaled $4.3 billion and Vanda hopes to capture about 25 percent of that market, Polymeropoulos said. The company is looking for a major pharmaceutical company to partner with in the promotion, sale and distribution of the drug, Polymeropoulos said.
Vanda, which employs 45 workers in Rockville, also has several other drugs in clinical trials, including one that treats schizophrenia, Iloperidone. Vanda is on track to apply for FDA approval for Iloperidone by the end of 2007.
Bloomberg contributed to this report.
