Endo Announces Topline Results From Phase 2 Study of Axomadol in Chronic Low Back Pain
CHADDS FORD, Pa., June 30, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced today topline results from a phase 2 study comparing the novel investigational drug axomadol against placebo in the treatment of patients with moderate to severe chronic low back pain. The results indicate that axomadol did not meet predetermined study end points. The company is currently completing additional analyses of the data and evaluating the path forward for the program.
The study was a randomized, double blind, two-arm, placebo-controlled, parallel group design and included 236 patients with moderate to severe chronic low back pain. Axomadol was orally administered at doses ranging from 100 mg/day to 300 mg/day over a four-week period with a 12-week maintenance phase. The primary outcome measure was change in average pain intensity using a Numerical Rating Scale (NRS) from baseline to final week of treatment for all patients receiving at least one dose of study drug.
Endo licensed exclusive rights to develop and market axomadol in the United States and Canada from Grunenthal in February 2009.
About Endo Pharmaceuticals
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, Inc., HealthTronics, Inc. and