Arena Pharmaceuticals, Inc., based in San Diego, CA, announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, a new drug candidate for weight management, including weight loss and maintenance of weight loss.
The company has had the medication in 18 clinical trials involving over 8,500 patients. The Phase 3 clinical trial program, called BLOOM (Behavioral Modification and Lorcasering for Overweight and Obesity Management) and BLOSSOM (Behavioral Modification and Lorcaserin Second Study for Obesity Management) evaluated approximately 7,200 patients treated for up to two years with 10 milligrams of lorcaserin, and consistently produced significant weight loss with excellent safety and tolerability.
William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer, stated, “Physicians need new, better-tolerated approaches to improve the treatment of patients who are obese or significantly overweight. Based on the robust data package we submitted to the FDA, lorcaserin has the potential to meet this need, offering patients the opportunity to achieve sustainable weight loss in a well-tolerated manner and improve their cardiometabolic health and quality of life.”
Lorcaserin works by stimulating the serotonin receptors in the hypothalamus of the brain, which is strongly associated with feeding behavior and satiety. Indications for patients who would be appropriate candidates for lorcaserin include those with a body mass index (BMI) between 30 and 45 with or without co-morbid conditions, or patients with BMI between 27 and 29.9 with at least one medical condition affected by obesity, such as hypertension or type 2 diabetes.
Two other companies are competing with Arena to become the first prescription weight loss drug approved in a decade. Vivus Inc is currently in a late-stage clinical trial with its drug called Qnexa, a combination of phentermine and an epilepsy medication called topiramate. Orexigen Therapeutics Inc plans to file for approval next year for its drug Contrave, which combines the antidepressant Wellbutrin with naltrexone, and opioid blocker used to treat alcoholism.
The Centers for Disease Control estimates more than a third of U.S. adults are obese. But pharmaceutical companies have had difficulty developing weight loss medications because of significant side effects which need to be minimized for the drugs to be used over a long period of time. The most common side effects of prescription weight loss drugs include increased heart rate, increased blood pressure, insomnia, gastrointestinal distress, or headache.
Currently, there are only two prescription drugs approved by the FDA for long-term weight loss. Meridia (sibutramine) made by Abbott Laboratories also works on the serotonin receptors in the brain to promote satiety and reduced calorie intake. Xenical (orlistat) made by Roche prevents the absoprtion of fat in the intestine. Alli is a reduced strength version of orlistat and available over-the-counter. Adipex-P (phentermine) is another approved medication, but should only be used for a short period of time, generally less than 12 weeks.
Weight loss drugs are not intened to be used as a stand-alone treatment for obesity. Dieters must still follow a low-calorie diet and regular exercise to maximize weight loss.