ENDO REPORTS RESULTS FROM SECOND STUDY OF EXTENDED-RELEASE OXYMORPHONE

Penwest Pharmaceuticals has announced that Endo Pharmaceuticals, Penwest's partner in the development and commercialization of oxymorphone extended-release tablets, has reported positive results from the second of two Phase III clinical trials of oxymorphone ER. In this multicenter, randomized, double-blind, parallel group trial, the safety and efficacy of
oxymorphone ER were compared with placebo in 142 opioid-experienced patients with moderate-to-severe chronic low back pain.

Oxymorphone ER demonstrated a statistically significant difference in pain scores from placebo during a 12-week treatment period, during which the drug was administered twice daily. The primary endpoint was change in average pain intensity from baseline to final study visit. In the study, which centered on opioid-experienced chronic low back pain patients, oxymorphone ER was generally well-tolerated with no single adverse event reaching an incidence of over 10 percent in either group.

Oxymorphone ER is a semisynthetic u-opioid agonist that has been formulated as a 12-hour extended-release tablet using Penwest's TIMERx delivery system. The drug has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, postsurgical pain and cancer pain.