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www.fdanews.com/articles/61649-pharmos-begins-study-of-cannabinoid-drug-for-pain

PHARMOS BEGINS STUDY OF CANNABINOID DRUG FOR PAIN

August 11, 2006

Pharmos has begun a second Phase IIa clinical study of cannabinor (PRS-211, 375) for the treatment of pain. The proof-of-concept trial will test for analgesic activity and the safety of cannabinor, a CB2-selective synthetic cannabinoid drug candidate, in healthy subjects experiencing capsaicin-induced pain.

The company also noted that patient enrollment continues in its first Phase IIa clinical trial of cannabinor as a treatment for nociceptive pain in third molar dental extraction that is expected to be completed in the third quarter of 2006.

Cannabinor will be administered intravenously in the single-center, randomized, double-blinded study. The safety and analgesic efficacy of cannabinor will be compared with placebo on capsaicin-evoked allodynia (pain resulting from a non-noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense). The study will include 24 male subjects in a two-way crossover design. In addition to the intravenous formulation, Pharmos is developing an oral formulation of the drug candidate for clinical development for chronic pain conditions.