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BLOSSOM data confirm safety, efficacy profile of lorcaserin in overweight adults

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The Obesity Society’s 27th Annual Scientific Meeting

Lorcaserin increased weight loss, was well tolerated and was not associated with valvular insufficiency in overweight and obese adults in the BLOSSOM study.

Data presented today “confirm utility of the 5HT2C receptor as the appropriate, effective, selective target,” Lee M. Kaplan, MD, director of the Weight Center at Massachusetts General Hospital, said during a late-breaking presentation.

Lorcaserin hydrochloride (Arena Pharmaceuticals) is an oral agent currently being evaluated in a phase 3 clinical trial program for weight management. Lorcaserin is the first in a new class of selective serotonin 2C receptor agonists, and is thought to have an effect on feeding behavior and satiety.

BLOSSOM is a randomized, double-blind, placebo-controlled, phase 3 study that includes 4,008 overweight or obese men and women (mean age, 43.8 years; 79.8% women). Researchers randomly assigned participants to lorcaserin 10 mg twice daily, 10 mg once daily or placebo for 52 weeks. Participants also followed a 600-calorie deficit diet and moderate exercise plan.

Participants assigned to twice-daily lorcaserin lost 5.8 kg, those assigned once-daily lorcaserin lost 4.7 kg and those assigned placebo lost 2.9 kg (P<.0001).

About 47% of participants assigned to the twice-daily dose and 40% assigned to the once-daily dose achieved a weight loss of 5% compared with 25% assigned to placebo. Further, 22.6% of the twice-daily group, 17.4% of the once-daily group and 9.7% of the placebo group achieved a weight loss of 10%.

Headache, nausea and dizziness were the most commonly reported adverse events associated with lorcaserin. There was no evidence of increased echocardiographic valvular regurgitation (P>.999), Kaplan said.

BLOSSOM is one of three trials in the phase-3 program for lorcaserin; the others are BLOOM and BLOOM-DM. BLOOM and BLOSSOM comprise the phase-3 pivotal registration program, and will be the basis for the New Drug Application submission to the FDA. – by Jennifer Southall

For more information:

• Kaplan LM. Late-breaker presentations. Presented at: the Obesity Society’s 27th Annual Scientific Meeting; Oct. 24-28, 2009; Washington.