JAMA Publishes Positive Results from Phase II Clinical Trial in Neuropathic Pain with Cannabinoid Compound under Development By Indevus
Tuesday September 30, 4:07 pm ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Sept. 30, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced the publication of data by the Journal of the American Medical Association showing that a novel synthetic anti-inflammatory and analgesic cannabinoid compound known as IP 751 (also as CT-3) significantly reduced the degree of neuropathic pain in a Phase II clinical trial without causing psychoactive adverse events (JAMA 2003; 290(13): 1757-1762).
The two-week crossover design trial was conducted by a team of investigators at the Hannover Medical School in Germany led by Matthias Karst, M.D., Ph.D. The 21 patients in this trial had chronic neuropathic pain syndromes as a result of previous spinal or peripheral nerve injuries, despite receiving standard pain medication therapy that continued during the trial. For inclusion, they had to have experienced pain for at least six months, although the average duration of their pain syndromes was greater than ten years.
Patients were randomized to receive placebo or IP 751, 20 milligrams given twice a day during the first four days and 40 milligrams twice a day during the remaining three days of the first treatment week. After a washout period of one week, patients were crossed over to the alternative therapy for another week.
The degree of pain experienced by patients, as measured by visual analog scores (VAS), decreased significantly during periods of treatment with IP 751 (p=0.02). In addition, no significant differences were observed between IP 751 and placebo with respect to measurements of cognitive function and prototypic subjective experiences, thereby demonstrating a lack of psychoactive effects accompanying the administration of IP 751 in this trial. IP 751 was therefore shown to be effective in reducing chronic neuropathic pain and was well tolerated, with no major adverse psychological or physical effects observed.
snip |
