FDAnews Drug Daily Bulletin


Dec. 12, 2005

The FDA has asked Johnson & Johnson (J&J) to conduct an additional clinical trial for its experimental pain medication Oros -- a move that will delay U.S. competition for Penwest Pharmaceuticals, which plans to market a competing product.

J&J's Alza subsidiary recently said that it was "considering different options" for Oros (hydromorphone) after learning from the FDA that it will need to provide additional clinical data to meet FDA approval standards for the drug, a once-a-day oral opioid for chronic pain. The drug is seen as a strong competitor to Penwest's experimental twice-a-day extended-release pain drug Oxymorphone ER (oxymorphone). "The decision to modify the clinical development program was not related to any safety issues with the medication," Alza said in a statement.

An additional clinical trial could delay the U.S. launch of Oros by two years, Glenn Novarro of Banc of America Securities writes in a recent note. J&J's product was originally expected to hit both the European and U.S. markets in the first quarter of 2007.

Penwest and development partner Endo Pharmaceuticals will now "have at least a year to market Oxymorphone ER without another branded opioid competitor on the market," writes Banc of America Securities analyst David Maris in a recent note. Maris predicts Penwest and Endo will launch their product in early fourth quarter 2006.

J&J also advised doctors that its anemia drug Procrit (epoetin alfa) may cause pure red cell aplasia (PRCA) in patients, causing the FDA to revise prescribing information for the drug. PRCA is a very rare adverse event seen with epoetins. In these rare cases, red blood cell production in affected patients shuts down.

However, the news is not expected to hurt Procrit's U.S. market share because anemia drug maker Amgen also told doctors on that its anemia drugs Aranesp (epoetin alfa) and Epogen (epoetin alfa) can cause aplasia in patients, Maris said