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Pharmos gets U.K. approval to start phase 2a pain-relief study
By Elaine Rigoli
Tampa, Fla., June 20 - Pharmos Corp. said it has received approval from the Medicines and Healthcare Products Regulatory Agency and the local Ethics Committee in the United Kingdom to start a phase 2a clinical study of cannabinor (PRS-211,375), a CB2-selective synthetic cannabinoid drug candidate for the treatment of pain.
The single-center, randomized, double-blinded, single-dose intravenous study will take place at the UCL Analgesia Centre in London, according to a news release.
The safety and analgesic activity of different cannabinor doses will be compared with a placebo for acute pain following extraction of mandibular third molar teeth.
The study will include 100 male subjects and is expected to be completed in the third quarter of 2006.
The dental pain model has proven to be relevant for other acute pain situations including post-operative pain, the release said.
Pharmos said a study to test cannabinor in other clinical pain models is planned for later this year.
Iselin, N.J.-based Pharmos develops therapeutics to treat a range of indications, including neurological and inflammatory disorders.
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