Arena says FDA has questions about insomnia drug APD125

By Elaine Rigoli

Tampa, Fla., March 29 - Arena Pharmaceuticals, Inc. received correspondence from the Food and Drug Administration seeking clarification of certain non-clinical issues in its Investigational New Drug application for APD125, which seeks approval to conduct a phase 2 clinical trial in patients with chronic insomnia.

The issues raised by the FDA may be resolved using available data, but the FDA may require Arena to generate additional data, according to a news release.

If no additional data are required, Arena said it will start the phase 2 trial around mid-year. If additional data are required, Arena expects the start of the trial will be delayed until the fourth quarter of 2006.

In either case, Arena said the delay will not affect the company's longer-term timeline of submitting a New Drug Application in 2009.

Arena also said toxicology studies from its program for APD356, an orally administered, internally discovered drug candidate for the treatment of obesity did not demonstrate any apparent drug effect on heart valves or pulmonary vasculature.

Arena expects to start the APD356 phase 3 program in the second half of 2006, the release said.

Arena is a San Diego-based clinical-stage biopharmaceutical company focusing on metabolic, central nervous system, cardiovascular and inflammatory diseases.

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