The trials also found that while 2.7% of patients on lorcaserin 10 mg twice daily, compared with 1.4% in the placebo group, reported adverse events mapped in a broad categorization of depression, there was no imbalance in treatment groups when depression-related AEs were confined to a narrower category.
Memory impairment, disturbance in attention, amnesia, and other cognitive AEs were reported infrequently overall, but three times more often in the lorcaserin 10-mg-twice-daily group than in subjects treated with placebo.
There were no imbalances in reports of cancer between lorcaserin and placebo patients in the phase III trials, but a number of malignant tumor types developed in rats treated with lorcaserin for as long as two years. The excess risk of malignant breast tumors is related to lorcaserin-mediated increases in serum prolactin, the company says, but FDA reviewers say there are not enough data to support this hypothesis.
Lorcaserin targets activation of the serotonin 5HT2c receptor to promote pre- and postmeal satiety. Arena’s proposed indication is for weight management, including weight loss and maintenance of weight loss in obese patients (body mass index of at least 30 kg/m2) or overweight patients (BMI of 25-29.9 kg/m2) who have one or more weight-related comorbid medical conditions.