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.
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