‘Son of Redux’A New Drug For Weight Loss Passes First Safety Test

Obesity Pill Faces Long Wait

Arena’s drug, lorcaserin, was born out of one of the drug industry’s greatest disasters: Redux, or fenfluramine, a Wyeth medicine that was yanked from the market after it was found to cause heart valve damage. The resulting drug liability tort became the biggest ever, forcing Wyeth to take charges of $21 billion.

Lorcaserin works by the same basic mechanism as Redux, but Arena is betting that Redux’s problems were the result of hitting two many other biological receptors in addition to the one that reduces appetite. This new drug, the company argues, shouldn’t cause heart valve problems. That’s why today’s news is so important: an independent committee assigned to watch over Arena’s drug study has said that it is ethical to keep giving patients the drug.

One big question is how long patients have to be followed in order to be reasonably sure that lorcaserin is free from the problems that afflicted Redux, and that will probably take at least 12 months.

Lorcaserin could be a huge drug, but it won’t be an easy sell. And it’s hard to see how anyone can have a clue if it can get past the FDA once Arena’s trials finish.