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Topamax Not Effective for Obesity, Diabetes

Dec 6, 2004

Johnson & Johnson last Wednesday said its epilepsy drug Topamax was not effective as a treatment for obesity and diabetes.

J&J, which earlier this year received a letter from U.S. regulators warning the company to stop circulating promotional material that failed to disclose serious risks associated with the drug, said it won’t continue to develop Topamax for these conditions.

Topamax, which is approved to treat epilepsy and prevent migraines, has annual sales of $1.4 billion. Johnson & Johnson said its decision to abandon its study of the drug in obesity and type 2 diabetes, the most common form of the disease, came after it examined the results of a mid-stage, or phase II, clinical trial.

The company said the study, which tested a controlled-release version of the drug against the existing immediate-release version, showed no significant advantage for patients taking a controlled-release version.

The company had previously tested the immediate-release version in obesity patients but stopped because of unfavorable side-effects.

J&J said its decision to drop the program was not based on any new safety data and said it does not impact use of the drug in any currently approved uses or other clinical development programs.
FACT: People with diabetes lose about eight workdays per year, in contrast with people without diabetes, who are absent on average 1.7 days. In addition, diabetic employees cost company health plans about $4,000 more each year than nondiabetic beneficiaries.