(dailyRx News) An advisory panel for the Food and Drug Administration has voted 18 to 4, with one person not voting, in favor of accepting a new weight loss drug called Lorqess.
This vote is a preliminary step before the FDA makes a decision on the drug, which the company expects will occur by June 27.
Lorqess, lorcaserin hydrochloride, reduces patients' hunger so that they lose weight. It works by acting on the part of the brain that is responsible for a person's appetite and metabolism.
Lorqess works similarly to the drug fenfluramine, the active ingredient in Fen-Phen, which is now banned because of the heart problems it was found to cause.
The company website states that Lorqess is more "selective" than fenfluramine and has not been shown to cause similar heart problems in clinical trials.
However, it's unclear if a sufficient number of clinical trials have produced enough data to rule out the possibility of heart problem side effects.
The manufacturer of Lorqess, Arena Pharmaceuticals, submitted the drug to an FDA advisory panel initially on October 22, 2010, but the drug was rejected for lack of sufficient safety data.
Arena conducted several additional trials and presented evidence to rule out any connection between Lorqess and cancer, according to Arena's website on the drug. The FDA had then accepted the resubmission of the drug application on January 10 this year.
A 12-week Phase 2 trial of Lorqess showed that people taking the drug lost more weight than the group taking the placebo. Those taking 10mg of Lorqess lost an average of 4 pounds, those taking 15 mg lost an average of 5.7 pounds, and those taking 20 mg lost an average of 8 pounds.
In the one-year Phase 3 trial, over 3,000 obese patients took a 10mg tablet of Lorqess twice each day. The average patient lost about 5.8 percent of their body weight - about 12.7 pounds - compared to those taking the placebo, who lost 2.2 percent of their weight - about 4.7 pounds.
The most common side effect reported from the trials included headaches, which 18 percent of the participants experienced, though 11 percent of the placebo participants also reported headaches.
Other side effects reported by the company from the trials included dry mouth, fatigue, nausea, vomiting and dizziness. The company reported that the same number of people - 7 percent - chose to quit taking Lorqess during the trial as those who chose to quit taking the placebo.