Biotech, Insomnia, Drugs

Arena Insomnia Pill Fails in Clinical Trial, Halts Development of Drug

Luke Timmerman 12/9/08

Arena Pharmaceuticals is scrapping development of its experimental insomnia medicine, after it failed to reach its primary and secondary goals in a clinical trial of more than 700 patients. The San Diego-based biotech company (NASDAQ: ARNA) didn’t have much more to say than that, other than it’s in a hurry to turn the page and look forward to results next year for another treatment in the works for obesity.

Arena has been eagerly anticipating a positive finding for this drug, APD125, so it could become a viable second candidate behind its lead horse, lorcaserin for obesity. The insomnia medicine was not a generalized sedative like Sanofi-Aventis’ zolpidem (Ambien) so it was hoped the newer medicine could help people stay asleep at night, without having the morning grogginess of other meds.

Now investors in Arena will turn their attention again to an even bigger event for the company. It expects to unveil a two-year analysis in March from a clinical trial of lorcaserin. The trial, called Bloom, enrolled almost 3,200 patients seeking to lose weight. The medicine is meant to stimulate a protein in the brain that makes people feel full, without triggering a similar protein that caused Wyeth’s fen-phen drug combination to damage patients’ heart valves before it was pulled off the market in 1997. If Arena can show its drug passes the safety test, and helps people shed pounds, then it expects to file an application with the FDA for permission to sell the drug by the end of 2009.

The company is planning to discuss the next steps for lorcaserin, and other drugs in development, at its R&D day with analysts on Dec. 15.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.