Obesity Drug Rolls Toward Approval Fda Panel Also Recommends Sale Of Nicotine Gum

The first new weight-loss drug in more than 20 years moved a step closer Thursday to federal approval.

In presentations to a Food and Drug Administration advisory committee, medical specialists said experimental studies with the drug, known as dexfenfluramine, showed most obese patients who took daily doses for six months registered weight losses of 5 percent to 10 percent. The patients were kept on a diet of 900 calories a day.

After discussing results of the drug at a daylong hearing, the panel on endocrinologic and metabolic drugs concluded the drug was effective. But some panel members raised questions about its safety, saying they leaned toward full approval only after safety questions are resolved in the coming weeks. The agency almost always follows its committee recommendations.

In a separate action, another FDA panel heard former Surgeon General C. Everett Koop and other public health authorities extol the benefits of a nicotine-laced chewing gum, which drug manufacturer SmithKline Beecham of Philadelphia wants the agency to approve for over-the-counter sales. Known as Nicorette, it is currently available by prescription only.

Koop said smokers who want to quit should be given all assistance possible that has proven to be safe, and “I believe nicotine gum is one of those treatments.”

That panel later voted unanimously to recommend over-the-counter sales of the gum.

Discussing the weight-loss drug, which manufacturer Interneuron Pharmaceuticals Inc. calls Redux, Dr. Bobby W. Sandage Jr., an obesity specialist, said 15-milligram daily doses in both sixmonth and 12-month trials “produced a significant beneficial effect” on its users.

However, as the first new obesity drug since 1973, dexfenfluramine has been shown to cause brain damage in animals at very high doses. Panel members said they needed to resolve questions about that even though the manufacturer claimed that the levels suggested for human weight loss are too low for any concern.

Chairman Dr. Henry G. Bone, senior staff physician at the Henry Ford Hospital in Detroit, said his committee would delay a recommendation for the time being in view of safety questions.

To date, the majority of approved obesity drugs are amphetamines, which can be addictive. However, Dr. Theodore J. Cicero said on behalf of the manufacturer that dexfenfluramine “has a remarkably low record of abuse, with no reported cases in the world since 1970.”

Judith Stern, vice president of the American Obesity Association, told the panel that “we are literally in the midst of an obesity epidemic” with the need for a better drug to treat an estimated 78 million dangerously overweight Americans.