NDA submitted for pain control drug

Published: 2-Jan-2003


Endo Pharmaceuticals, based in Chadds Ford, PA, US, has submitted a New Drug Application (NDA) to the US Food and Drug Administration for oxymorphone extended release tablets. The product uses TIMERx Penwest Pharmaceuticals' proprietary controlled release drug delivery technology.

Oxymorphone ER is an oral extended-release opioid analgesic that was jointly developed with drug delivery company Penwest for the treatment of moderate to severe pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time.

'Oxymorphone ER is our lead development program and we are very excited that the NDA has been submitted to the FDA. We believe oxymorphone ER is an excellent example of how TIMERx can add value to medicines for both consumers and our partners,'said Tod Hamachek, Penwest's chairman of the board and ceo.

If approved oxymorphone ER, would give physicians and their patients an important new option for managing chronic pain with twice-daily dosing, and would compete in the growing, approximately US$2bn (Euro 1.91bn) market for long-acting oral opioids.

The filing is based on a development program involving more than 2,400 patients.

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