FDA approves Endo's, Penwest's painkillers Opana and Opana ER

Penwest Pharmaceuticals and its development and commercialisation partner Endo Pharmaceuticals announced Friday that the FDA has approved their opioids Opana (oxymorphone hydrochloride) and Opana ER. Both the immediate-release and extended-release formulations of the drug are indicated for the relief of moderate-to-severe pain, with Opana for acute pain and Opana ER for chronic pain.

"This is the first time oxymorphone will be available in an oral, extended-release formulation," according to an Endo statement. Endo also raised its projected annual revenue range to $880 million to $910 million from $860 million to $880 million but said its launch costs will result in lower profits. The company expects combined sales between $20 million and $30 million for both Opana formulations.

Endo said it plans to release both forms of the drug in the coming weeks and to expand its 370-person sales force by about 220 to market Opana and Opana ER as well as its existing portfolio of branded pain relief products. In a research note, Jefferies & Co. analyst David Windley said he plans to increase earnings per share estimates for Endo to reflect its "aggressive sales force expansion in 2006," MSN Money reported.

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