J&J Will Not Pursue Topamax for Obesity

Another developmental obesity drug bit the dust Monday when Johnson & Johnson (NYSE: JNJ) announced that it was discontinuing clinical trials for Topamax (topiramate). Although not releasing data, J&J said that Topamax, presently marketed and indicated for the treatment of various types of seizures, proved efficacious at reducing weight but raised adverse effect concerns among patients taking high doses. Since the drug was launched for seizure management in 1995, a significant proportion of recipients have reported weight loss. The adverse effect profile in mid-to-late stage clinical trials in obesity included memory problems, fatigue, sleepiness, difficulty in concentration, and tingling in the fingers and toes.

Instead of continuing current trials, J&J will attempt to improve the adverse effect profile of Topamax. Using technology developed by the recently acquired Alza Corp., J&J plans to develop a controlled-release formulation of the drug.

So far, Topamax has followed the rather disappointing precedent set by other potential obesity drugs. Obesity has proven to be difficult to target, perhaps because of the complexity of factors governing weight control. Even the most common form of obesity, diet-induced obesity, has a complex pathophysiology for which fundamental protein targets are both poorly understood and involved in multiple metabolic and physiologic pathways such that modifying their activity is fraught with adverse effects. The most notorious obesity treatment was a combination known as fen-phen, which was recalled from the market in 1997 after it was associated with heart valve damage, adverse cardiovascular effects, and other serious ailments in an unacceptably high proportion of recipients. Many other anti-obesity agents have failed in clinical trials. Nothing currently in the clinical trial pipeline to treat obesity appears to be able to overcome these and other limitations.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
February 8, 2002

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