Tuesday, Arena Pharmaceuticals Inc. (ARNA) announced that it has submitted a New Drug Application or NDA to the US Food and Drug Administration or FDA for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients, the company said.
The pivotal Phase 3 clinical trial program, BLOOM or Behavioral modification and Lorcaserin for Overweight and Obesity Management and BLOSSOM or Behavioral modification and LOrcaserin Second Study for Obesity Management, evaluated nearly 7,200 patients treated for up to two years and showed that lorcaserin consistently produced significant weight loss with excellent safety and tolerability.
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