First Approval Of AHP's Duract

American Home Products' Wyeth-Ayerst subsidiary has been given marketingapproval in the USA for Duract (bromfenac sodium capsules), a new and potent non-narcotic analgesic.

This is the first world approval for the drug, which builds on Wyeth's established pain franchise with products such as the Orudis (ketoprofen) line. The product is intended for the short-term management of pain (generally less than 10 days) . Side effects are similar to other cyclo-oxygenase inhibitors (ie mostly gastrointestinal), and also include elevations in liver enzymes. The company recommends that liver enzyme levels be monitored in patients receiving the drug for more than four weeks.

Wyeth notes that trials have shown that Duract is effective in the management of acute pain in a wide range of applications, including postoperative use following major abdominal, gynecologic, oral, or orthopedic surgery. The drug should be launched in the next few weeks, and will be competitively priced. Early reports say that it will be set at around the same level as Johnson & Johnson's Ultram (tramadol), but lower than Roche's Toradol (ketorolac) and Novartis' Cataflam (diclofenac K).