The Food and Drug Administration delayed its decision whether to approve a new obesity drug Wednesday. The agency will take another three months to consider drugmaker Orexigen’s application, the company said. If regulators eventually say OK, the medication, known as Contrave, would be the third weight-loss drug to reach the market in the past few years. Like the other two, it’s unlikely to put a dent in America’s obesity epidemic.
About 35 percent of American adults are obese, according to the Centers for Disease Control. Another third are merely overweight. Physician groups last year designated obesity as a disease. Despite the urgency of the problem, doctors and patients have had a lukewarm response to the latest meds. That’s partly because the drugs are only modestly effective. Patients and doctors also haunted by an earlier generation of diet drugs that were pulled from the market because of sometimes lethal side effects.
Dr. Daniel Neides, medical director of the Cleveland Clinic’s Wellness Institute, was fresh out of his residency when the FDA approved an appetite suppressant called Redux in 1996. While the drug helped people lose weight, “the problem was that it was killing them,” Neides says. It was pulled from the market the next year, along with fen-phen, another diet drug found to damage some patients’ heart valves. A third drug, Meridia, was taken off the market in 2010 because of concerns about heart problems.
This history has made physicians and regulators wary of weight-loss medications. The two obesity drugs to reach the market—Belviq, sold by Arena Pharmaceuticals (ARNA), and Qsymia, sold by Vivus (VVUS)—were initially rejected by the FDA but approved after the companies submitted further data. (This is also Contrave’s second time up for approval.) Consumer Reports has advised patients to stay away, and neither has been approved in Europe. Perhaps unsurprisingly, sales have been thin.
Part of the reason is that the benefits are small for most people who take them. “It’s really rare that you have patients that come back and say this is the greatest thing since sliced bread, I’ve done so well with this,” says Dr. Michael Jensen, a professor of medicine at the Mayo Clinic in Rochester, Minn. Jensen has been a paid consultant for weight-loss drug makers. “I think all the companies are finding it a challenge to get much traction with their medication,” he says.
In clinical trials, the average weight loss was only 4 percent to 8 percent above what patients taking placebos demonstrated, Jensen says. Those benefits, while medically important, may not be enough to offset such side effects as headaches or upset stomach as well as the co-pays for drugs that some insurers are reluctant to cover.
Orexigen Therapeutics (OREX), the company behind Contrave, is partnering with Japanese drugmaker Takeda Pharmaceutical (4502:JP) to market the medication in the U.S. if it’s approved. Company officials told analysts in an earnings call in May that they’ll target a broad audience of family doctors. Takeda would put 900 sales reps behind Contrave, “which we believe will deliver the scale, scope, and expertise to successfully reach a large and high potential audience of primary care physicians,” Orexigen Chief Executive Michael Narachi said, according to a transcript.
They may have a difficult time persuading physicians such as Neides. He’s skeptical that the benefits of new medications outweigh the risks, especially for obese patients, who may be taking medications for other health problems that interact with the new remedies in unknown ways. ”I want to know that I’m not going to harm my patients first and foremost,” Neides says.
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11 June 2014 | 4:02 pm – Source: businessweek.com