FDA denies approval for Somaxon sleep drug

The FDA has struck a blow to Somaxon Pharmaceuticals, saying it can't provide an approval for its sleep therapy Silenor without more data. According to Somaxon, the "raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor NDA and indicated that the FDA was open to a discussion of these concerns."

Somaxon added that the FDA asked the developer to "address the possibility that doxepin may prolong the cardiac QT interval. The company intends to respond by submitting to the FDA the results of its completed clinical trial of doxepin that evaluated the potential for electrocardiogram effects. As the company has previously disclosed, the results of this clinical trial demonstrated that doxepin had no effect on QT interval prolongation when administered at 6 mg or 50 mg."

Somaxon said that the FDA did not specifically demand a new trial, which would seriously delay any approval, and that it would seek a meeting with regulators as soon as possible. But at least one analyst was quick to note that the agency's decision was very bad news for Somaxon. Analyst Corey Davis of Natixis Bleichroeder says an FDA OK for the sleep therapy is "only a remote possibility" as it indicates that the agency does not see the therapy as a significant improvement over drugs already on the market.

- take a look at Somaxon's release [1]
- check out the AP report [2]

Related Articles:
Somaxon secures cash for Silenor marketing [3]
Somaxon CEO resigns [4]
Somaxon touts latest Phase III results for Silenor [5]