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Topiramate Trial in Obesity and Diabetes Discontinued
A controlled release formulation of topiramate was specifically developed for study in obese individuals with Type 2 diabetes to potentially simplify dosing and enhance the compound's profile in order to create a better treatment option for patients. 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.
This decision is not based on any new safety information and does not impact the use of topiramate, marketed as TOPAMAX® (topiramate/topiramate capsules), in any currently-approved indications or clinical development programs underway. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., remains committed to developing innovative medicines for the treatment of metabolic disease.
TOPAMAX® is marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, and 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. For more information on TOPAMAX®, please see full prescribing information or visit www.ortho-mcneil.com.
Source: Johnson and Johnson