San Diego-based Arena Pharmaceuticals, Inc. (ARNA) said Tuesday that it has submitted a New Drug Application to the US Food and Drug Administration for its weight management drug candidate, lorcaserin. The company added that the submission is based on the positive results from a late stage study, including 18 clinical trials totaling 8,576 patients.
The Phase 3 clinical trial program evaluated nearly 7,200 patients treated for up to two years and found that lorcaserin produced significant weight loss with safety and tolerability. In addition to the late stage study, Arena is evaluating lorcaserin in obese and overweight patients with type 2 diabetes in its BLOOM-DM trial, which is planned as a supplement to the NDA.
Lorcaserin, an oral agent, selectively stimulates the 5-HT2C receptors located in the brain's hypothalamus region, which assists in appetite suppression and metabolism activities.
According to the National Institutes of Health's 2007 report, about 65% of US adults are obese, and a publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008.
Jack Lief, President and Chief Executive Officer, said, "Physician feedback suggests that, if approved, lorcaserin's combination of efficacy, safety and tolerability will position the drug candidate as first-line therapy for weight management."
Arena said it has patents that cover lorcaserin in the US and other jurisdictions, and mostly capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity it might obtain.
ARNA is currently trading at $3.82 per share, up 2.14%, on the Nasdaq.
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