FDA Rejects Somaxon’s Application for Insomnia Drug

San Diego specialty drugmaker Somaxon Pharmaceuticals, (NASDAQ: [[ticker:SOMX]] said today the FDA turned down its application to market a new drug for insomnia. Somaxon says the FDA raised a number of issues related to the interpretation of the efficacy data in its new drug application.

The company says the FDA did not specifically ask it to conduct additional clinical trials of its drug candidate, doxepin (Silenor). But the FDA asked the company to address the possibility that the drug may prolong the heart’s QT interval—a key measure of the heart’s electrical rhythm.

Somaxon says it plans to collect additional data from already completed clinical trials that evaluated the drug’s potential effect on the heart’s electrical cycle. Results of the test previously disclosed by Somaxon show doxepin had no effect on prolonging the QT interval when administered at doses of 6 milligrams or 50 milligrams.

The company noted that doctors have been prescribing doxepin for more than 35 years for the treatment of depression and anxiety at dosages of 75 milligrams to 300 milligrams a day. Somaxon is seeking approval for a low-dose oral tablet formulation at 1 milligram, 3 milligrams, and 6 milligrams for treating insomnia.

Somaxon says a discussion with the FDA will be necessary to gain a complete understanding of the concerns raised by the agency. “As we continue to seek approval of Silenor, we will continue to take measures to conserve our cash and will evaluate financing alternatives available to us,” Chief Executive Richard Pascoe said in a statement.

Somaxon shares dropped more than 50 percent after the bell, losing $1.12 in after-hours trading before settling at $1.02 at 6:20 pm ET.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.