FDA approval expected for obesity drug


A US Food and Drug Administration advisory panel has approved a prescription treatment for obesity, an action expected to bring significant royalty income to MIT which holds a "use" patent on the drug involved in the treatment.

FDA advisory-panel approval almost invariably is followed by the approval of the FDA.

The treatment, which involves the use of dexfenfluramine to curb carbohydrate craving, was pioneered by the work of Judith Wurtman, a research scientist in the Department of Brain and Cognitive Sciences, and Professor Richard J. Wurtman, MD, of the same department. Professor Wurtman is also director of the Clinical Research Center where work on the development of the treatment began in the early 1970s. The Wurtmans are husband and wife

Lita Nelsen, director of the MIT Technology Licensing Office, said the Institute holds both US and foreign patents on the use of dexfenfluramine to curb carbohydrate craving. The patent was issued in 1980. In 1981 MIT licensed Laboratory Servier of France to market dexfenfluramine for this use. Servier discovered fenfluramine, a mixture of right- and left-handed fenfluramine molecules, several years ago. Dexfenfluramine will be sold in the United States under the name Redux. It is also now sold in more than 60 countries under the names Isomerid and Adifax.

In 1990, MIT started Interneuron Pharmaceuticals, Inc., of Lexington, MA, with the Wurtmans as co-founders. Interneuron holds the US license for Redux. Richard Wurtman said US sales are expected to reach $600 million annually.

Ms. Nelsen declined to cite MIT's current or expected royalty income.

Judith Wurtman's work, beginning in the early 1970s, discovered dexfenfluramine's ability to curb carbohydrate craving by raising brain levels of serotonin, a neurotransmitter. In clinical tests, obese subjects were given meals of identical caloric value. Subjects had unfettered private access to a cost-free vending machine that dispensed carbohydrate snacks when the subject keyed in his or her code. Some subjects received dexfenfluramine, others a placebo. Subjects given dexfenfluramine showed a marked decrease in the use of the snack-dispensing machine, a finding that demonstrated both serotonin's role in carbohydrate craving and dexfenfluramine's ability to enhance serotonin levels.

Interneuron's announcement on the November 17 action quoted its chief executive, Glenn L. Cooper, MD, as saying that the approval by the FDA's Endocrinologic and Metabolic Advisory Committee was "a milestone. in the history of obesity therapy in the US. Redux is now positioned to become the first obesity drug approved for long-term use in this country."

A version of this article appeared in MIT Tech Talk on December 6, 1995.


Topics: Health sciences and technology

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