Endo provides additional safety, efficacy information to FDA for oxymorphone tablets

By Angela McDaniels

Seattle, Dec. 22 - Endo Pharmaceuticals Inc. said it has submitted responses to the Food and Drug Administration's request for more information on oxymorphone extended-release (oxymorphone ER) and immediate-release (oxymorphone IR) tablets.

The FDA issued approvable letters for oxymorphone ER and IR tablets in October but asked Endo to provide more clarification and perform additional clinical trials to further confirm the safety and efficacy of the products.

Endo conducted two separate multi-center, randomized, double-blind, parallel group trials evaluating this product in patients with opioid-naive and opioid-experienced chronic low back pain. The trial involving opioid-naive patients was conducted under the FDA's Special Protocol Assessment process.

Under the Prescription Drug User Fee Act guidelines, the FDA has 60 days to decide if the additional submissions meet its criteria for a complete response. If so, it will likely issue an action letter for each application within 180 days, the company said.

"We look forward to working with the FDA to bring both of these products to market. If approved, Endo will be prepared to launch oxymorphone ER and IR in the second half of 2006," president and chief executive officer Peter A. Lankau said in a company news release. Oxymorphone ER would compete in the long-acting, strong opioids market, estimated at $4.2 billion in 2004.

"We believe oxymorphone ER will give physicians an important new option for treating patients with moderate-to-severe chronic pain who require around-the-clock opioid therapy for longer than a few days," Lankau added.

Endo said Oxymorphone is a semi-synthetic mu-opioid agonist analgesic. Oxymorphone IR has been studied in post-surgical pain in doses varying from 5 mg to 20 mg.

Oxymorphone ER has been formulated as a 12-hour extended-release tablet using Penwest Pharmaceuticals' time-release TIMERx delivery system. It has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, post-surgical pain and cancer pain.

Endo is a specialty pharmaceutical company based in Chadds Ford, Pa., that develops branded and generic pharmaceuticals with a focus on pain management products.

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