Topamax as Potential Anti-Obesity Drug?
June 28, 2008 – 6:08 pm
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Johnson and Johnson announced it is discontinuing its current clinical development program for a time-release formulation of Topamax (topiramate) for use in treating in obesity — the latest weight-loss hope to fade as a result of troublesome side-effects.
Topamax is widely used to treat epilepsy and seizures, and clinical trials had suggested that it might also be highly effective in promoting weight loss.
But a clinical study of Topamax for weight loss was halted because of side-effects related to the central nervous system.
The most common side effect for those taking Topamax was paresthesia, a tingling, “pins and needles” sensation in the extremities, which occurred in 73 percent of patients taking the higher dose and 46 percent of patients taking the lower dose of the drug.
Topamax use was also linked to problems with memory. Some 18 percent of dieters in the trial taking higher doses of the drug reported memory problems, compared with 14 percent of those taking the lower dose and 6 percent of those taking a placebo.
Johnson and Johnson subsequently said it was attempting to develope a time-release version of the Topamax that it hoped would minimize side effects and be more appropriate for dieters.
“Data from a recently completed phase II clinical study with the controlled release formulation of topiramate showed that the controlled release formulation did not provide significant advantages in this population compared to previously conducted studies using the immediate release formulation,” Johnson and Johnson said in announcing it was halting development.
The company emphasized that the move was not based on any new safety information and did not impact the use of Topamax as an antiepileptic drug. It currently is approved to treat various types of epileptic seizures in more than 95 countries, and for the prevention of migraine headaches in more than 28 countries.