The U.S. Food and Drug Administration has appointed Ed J. Hendricks, M.D., a Sacramento-area obesity treatment specialist, to the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC). The EMDAC is the FDA-selected panel of experts that reviews new drugs for treating obesity, advising the FDA if these drugs should be approved. Dr. Hendricks, who has practiced Bariatric (Obesity Medicine) in Sacramento and Roseville since 1989, has served on this committee frequently over the past two years as an invited member. The FDA has been criticized because EMDAC panels repeatedly were populated entirely with experts on drug safety, statisticians, and endocrinologists with little experience in treating obesity and rarely included experts in obesity treatment. Dr. Hendricks is the only obesity treatment specialist appointed as a standing member of the panel. He is a triple-boarded physician with board certifications in Obesity Medicine, Clinical Pathology and Anatomic Pathology.
The appointment is timely; the FDA is expected to announce market approval for Arena Pharmaceutical’s Lorcaserin on June 27, 2012, and for Vivus Pharmaceutical’s Qnexa (Qsymia) on July 17, 2012. Lorcaserin is a novel drug; it is the first-ever drug that targets a central nervous system receptor in the eating regulatory system. Regarded as a replacement for fenfluramine, Lorcaserin does not trigger heart valve serotonin receptors, as fenfluramine did. Lorcaserin-treated clinical trial patients were watched carefully for new heart valve damage and none was observed. Qnexa is a fixed-dose combination of two older drugs, phentermine and topiramate.
It is anticipated that even though there is no evidence for Lorcaserin and minimal evidence for Qnexa having any harmful cardiovascular effect, the FDA will require post-approval cardiovascular outcome trials for both drugs and for all future new obesity drugs.
The expectation is both drugs will become available before the end of the summer and that knowledgeable and experienced obesity treatment specialists will combine both new drugs with phentermine to achieve better results. Currently Dr. Hendricks is already treating some patients with Qnexa-like combinations of phentermine and topiramate and with combinations of phentermine and another currently available serotonin agonist.Leave a reply →