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Ligand Pharmaceuticals Inc. (LGND) Release: Investigators Present Initial Results Of Two AVINZA Trials At APS; First Study Demonstrates AVINZA Advantages Over Oxycodone CR In Treating Chronic Back Pain
3/31/2005
SAN DIEGO--(BUSINESS WIRE)--March 30, 2005--
Second Study in Patients with Moderate-to-Severe Osteoarthritis Demonstrates Improved Sleep for AVINZA Patients
Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) announced the initial results from two studies to be presented in poster sessions at the American Pain Society annual meeting today in Boston. In the first study, its pain product AVINZA(R) showed better control of chronic pain and improved sleep in the initial results from this large comparator study comparing AVINZA given once daily to oxycodone CR(1) given twice daily. A second study demonstrated AVINZA's ability to provide better sleep as well as improved pain control for patients with chronic moderate-to-severe osteoarthritis.
The first study, referred to as ACTION (AVINZA Comparator Trials in Opioid Naive) is a randomized, multi-center, parallel-group study which enrolled 393 patients with moderate to severe chronic back pain and followed them for up to seven months. The study included a titration phase to allow all patients to have stable pain control at the initiation of the eight-week initial evaluation period. This was followed by a four-month extension phase to collect long-term pain control comparator information. It compared once-daily AVINZA (once-a-day morphine sulfate extended-release capsules) to twice-daily OxyContin(R) (oxycodone hydrochloride controlled-release). In initial results of the first phase of the study, with 212 evaluable patients (105 in the AVINZA arm and 107 in the oxycodone CR arm) followed through two months, the study showed that at lower, mean morphine-equivalent doses (72 mg AVINZA to 89 mg oxycodone CR), patients receiving AVINZA once daily demonstrated statistically significant better pain control (evaluated using the Brief Pain Inventory assessment instrument), statistically significant better quality of sleep (evaluated using the Pittsburgh Sleep Quality Index assessment instrument), and a statistically significant reduction in the frequency of required rescue medications. The final results from all patients in the study and the results from the extension phase to collect long-term comparator data are expected later this year.
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