Lorcaserin: Phase III data

In February 2007 draft guidance on developing obesity drugs, FDA recommends a 5% difference between active-product and placebo-treated groups in mean weight loss or for the active-product group to have approximately double the proportion of patients who lost at least 5% of baseline body weight vs. placebo. The data showed that lorcaserin met the latter benchmark in the trial, but not the former. The most common adverse events included headache, upper respiratory infection, back pain and nasopharyngitis. At week 24, 2.5% and 1.9% of lorcaserin and placebo patients, respectively, developed new valvulopathy, while 2.9% and 0.5% of patients had new valvulopathy at week 52. Arena said the trial was not powered to detect "meaningful" differences in the incidence of valvulopathy. The trial enrolled 604 patients to receive once- or twice-daily 10 mg lorcaserin or placebo for 52 weeks. Arena said that randomization to the once-daily 10 mg lorcaserin arm was discontinued after about 300 patients were enrolled in the trial in order to expedite enrollment. Analysis of the 95 patients who received the once-daily dose is ongoing. ...