Application for controlled release opioid using Penwest technology

Published: 1-Feb-2003
Regulatory


US company Endo Pharmaceuticals, based in Chadds Ford, PA, has submitted a New Drug Application (NDA) to the US FDA for oxymorphone extended release tablets. The product uses TIMERx, Penwest Pharmaceuticals' proprietary controlled release drug delivery technology. The filing is based on a development programme involving more than 2,400 patients.

Oxymorphone ER is an oral extended-release opioid analgesic that was jointly developed with 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 programme and we believe it is an excellent example of how TIMERx can add value to medicines for both consumers and our partners,' said Tod Hamachek, Penwest's chairman 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 market for long-acting oral opioids, which is worth approximately US$2bn (€1.91bn).

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