June 28, 2012
FDA Approves New Anti-Obesity Pill
Connie K. Ho for redOrbit.com
78 million. This is the number of people who are obese in the United States, according to the U.S. Center for Disease Control and Prevention (CDC). Obesity increases the risk of diabetes, heart attacks, and strokes. It also costs the U.S. economy $147 billion a year in expenses and lost productivity. With these dire facts in mind, the Food and Drug Administration (FDA) recently approved the anti-obesity prescription drug Belviq from Arena Pharmaceuticals to be sold on the market; the last time the agency made such a decision was 13 years ago.
Even though the drug only assisted with modest weight loss in clinical studies, it seemed to be safe enough to receive FDA approval. According to the Los Angeles Times, participants lost an average of 17 to 18 pounds with the drug. The pill will be allowed for adults who are overweight (Body Mass Index of 27) or obese (Body Mass Index over 30) with a minimum of one medical complication, like Type 2 diabetes, high blood pressure, or high cholesterol. Patients should use the drug, otherwise known as lorcaserin hydrochloride, along with practicing a healthy diet and participating in exercise. It provides a solution to doctors´ requests for new weight-loss treatments.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," noted Patrick O'Neil, the Obesity Society President and lead researcher on several studies of Belviq, in an article by the Associated Press (AP). "On the other hand, it´s not the answer to the problem – or even a big part of the answer."
According to WebMD, at a FDA hearing in May, past participants spoke about their experiences with the drug. One participant, Lisa Sutter, took the drug for a year during the clinical trial to lose extra weight she had gained during a pregnancy. She switched to the placebo part of the trial the second year and began to gain the weight back.
"When I was on the drug I was able to stick to a 1,500- or 1,600-calorie-a-day diet without feeling hungry“¦ And when I ate more than I planned to, I felt uncomfortably full, which is not something that I was used to,” stated Sutter in the WebMD article. "I'm not saying this drug is the answer for everyone, but it worked well for me."
Other experts believe that Belviq would pave the way for development of new treatments to combat obesity.
"The way these things tend to work is you have some people who do extremely well and other people don´t lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College, told the Associated Press.
Earlier in 2010, Belviq was denied for approval by the FDA. At the time, scientists were concerned about tumors that formed in animals who had participated in the studies of the drug. The company agreed to complete six post-market studies to determine the safety and effectiveness of the pill, which included a long-term cardiovascular outcomes trial to identify whether the drug had any risk for major cardiac issues like a heart attack or stroke. According to the San Francisco Gate Chronicle, Belviq is thought to function similarly to fenfluramine, which suppressed appetites with fen-phen but was removed from pharmacies 15 years ago due to a connection with heart valve abnormalities.
Earlier this year, the company resubmitted the drug with extra data and the FDA stated that there was little risk of tumors in humans. The FDA reported that the drug works with a chemical pathway in the brain that can decrease appetite by increasing feelings of fullness. In early 2013, Arena and its partner Eisai Inc are expected to launch the drug.
There are limitations on the pill as well. Pregnant woman should not use Belviq as the medication has serious side effects such as life-threatening increase of the chemical serotonin that could lead to fevers, muscle rigidity, and seizures. Combined with drugs that treat depression or migraines, the drug could be particularly damaging. Patients are also recommended to stop using the drug after 12 weeks if five percent of the weight loss has not been achieved.
In the past few years, doctors have been requesting the FDA to approve new weight loss treatments. However, many of the prescription drugs have been related to safety problems. After leaping over the FDA hurdle, when sold, Belviq could reap up to $2 billion by 2020 for Arena.
“Two-thirds of the people in this country are overweight or obese,” commented Edward Tenthoff, an analyst at Piper Jaffray & Co. in New York, in an interview with the San Francisco Gate. “It´s an enormous opportunity.”