Eisai and Arena announce top line results of lorcaserin HCl with phentermine HCl

Japanese drug major Eisai (TYO: 4523) and Arena Pharmaceuticals (NASDAQ: ARNA) have announced top-line results of a pilot study to assess the safety of lorcaserin HCl, a serotonin 2C receptor agonist, when co-administered with phentermine HCl.

The companies said the results of the investigational study demonstrate that the short-term combination of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone. They added that the co-administration of lorcaserin and phentermine for weight management is investigational. The efficacy and safety of co-administration of lorcaserin and other weight loss products such as phentermine have not been established.

The randomized, double-blind pilot study of 12-weeks duration in overweight and obese adults evaluated whether short-term treatment with lorcaserin 10 mg twice daily (BID) plus two doses of immediate-release phentermine, 15 mg once daily (QD) or 15 mg BID, is associated with exacerbation of potential serotonergic adverse events compared to lorcaserin alone. In the trial, 238 subjects were randomized to one of the three treatment arms in a 1:1:1 ratio and received standardized weight-loss counseling during the trial.