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Opana Painkiller Gets OK from FDA


Posted on 2006-06-23 09:33:00



Drug maker Endo Pharmaceuticals Holdings Inc. said Friday that the Food and Drug Administration approved two forms of its new painkiller, Opana, but lowered its outlook due to the cost of launching the products.

Shares of Endo shot up $2.25, or nearly 8 percent, to $31 in premarket electronic trading, having closed Thursday at $28.75 on the Nasdaq. Penwest Pharmaceuticals Co., Endo's development partner on Opana, saw shares skyrocket $3.91, or more than 24 percent, to $20 in premarket activity.

The FDA approved an extended-release and immediate-release form of the opiate painkiller oxymorphone hydrochloride, which the company will market as Opana ER tablets and Opana tablets, respectively. Both are indicated for the treatment of moderate-to-severe pain with Opana ER for chronic pain and Opana for acute pain.

However, the company said Penwest will not help pay for the launch of Opana ER, and so Endo must shoulder the full cost, resulting in lower profits. Penwest developed the controlled-release drug delivery technology in Opana ER. Endo said it will add 220 sales reps to its present sales force of 370 reps.