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
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