Arena Pharmaceuticals has disclosed results from the Behavioral modification and Lorcaserin second study for obesity management trial (BLOSSOM). BLOSSOM confirms the results previously reported for the Behavioral modification and Lorcaserin for Overweight and Obesity Management (BLOOM) trial and completes the lorcaserin phase 3 pivotal registration program of 7,190 patients evaluated for up to two years.
The company claims that in the one-year BLOSSOM trial, lorcaserin met all primary efficacy and safety endpoints. Lorcaserin was well tolerated and was not associated with depression or suicidal ideation. The integrated echocardiographic data set from BLOSSOM and BLOOM rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA.
Treatment with lorcaserin also resulted in improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. In patients treated with 10mg of lorcaserin dosed twice daily in a 52-week trial, 63.2% lost 5% of their body weight, and 35.1% of patients lost 10% of their body weight, the company reported.
Arena plans to submit a New Drug Application (NDA) for lorcaserin to FDA in December.
Steven Smith, executive director of the Florida Hospital Clinical Research Institute, said: “BLOSSOM demonstrated that nearly two-thirds of lorcaserin patients lost a medically meaningful amount of body weight while avoiding unwanted side effects and a complicated titration program.”
Jack Lief, president and CEO of Arena, said: “With its excellent safety and tolerability profile, we expect lorcaserin to change the way primary care doctors treat the broad cross-section of overweight and obese patients with pharmacotherapy. With the completion of our robust phase 3 pivotal program, we will focus on the NDA filing, work with the FDA during the review process and prepare for the commercialisation of lorcaserin.”