Lorcaserin, New Obesity Drug (continued)

By Dr. Ed Hendricks on March 30, 2009

     Arena Pharmaceuticals released today the first report of their initial 2-year phase 3 clinical trial for Lorcaserin. Although Wall Street analyists generally issued pessimistic opinions, careful analysis reveals that the new drug meets or exceeds FDA standards for approval. Furthermore the weight loss results are robust with nearly 50% of patients losing 5% of initial weight and nearly 25% losing 10%. Typically there is a marked genetic variation in patient response to obesity treatment, something FDA trials tend to obscure. A high percentage of patients who lose more than 5 and 10% suggests a very large population of obese patients will respond with impressive weight loss with Lorcaserin. The drug triggers specific brain serotonin receptors known to diminish carbohydrate cravings and diminish food intake. Patients receiving agents known to stimulate these receptors often comment on how easy it is to diet and lose weight. This factor alone should make this drug a very popular one with patients. Serotonin precursors have been used for weight management for decades and are known by obesity treatment specialists to be both safe and effecetive for seleced patients. A new report published online in the journal Obesity indicates that about 20% of bariatric specialists are now treating some patients with 5-Hydroxytryptophan and Carbidopa, a combination known to trigger the same serotonon receptors as Lorcaserin.

     Drop-out rates, typically at 50% at six months in lengthy obesity drug trials, were extraordinarily low indicating the patients who responded were highly satisfied with their results. This is a critical factor with any obesity drug since high drop-out rates generally mean patients won’t stick with a drug long enough to achieve success.  

     Also impressive was the paucity and lack of severity of adverse events. Early headache on nausea were the most frequent and were mild since evidently no patients dropped out because of such events. Intensve cardiac monitoring over the two years revealed absolutely no significant cardiac adverse reactions.

     From the perspective of a medical weight management specialist, Lorcaserin appears to be a very promising new drug. Arena intends to report results of two more clinical trials this fall before applying for FDA approval for Lorcaserin. Check back here for updates as new information becomes available.

Posted in Breaking News, Obesity Drugs |