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news.Pharmos Corporation has received approval from UK regulators to commence a phase IIa clinical study of its cannabinoid drug candidate for the treatment of pain.
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The proof-of-concept trial of the drug, PRS-211,375, will be conducted among healthy subjects experiencing pain following third molar dental extraction.
The single-center, randomized, double-blinded, single-dose intravenous study will take place at the UCL Analgesia Centre in London. The safety and analgesic activity of different cannabinor doses will be compared with placebo for acute pain following the extraction of the molar teeth.
The study will include 100 male subjects and is expected to be completed in the third quarter of 2006. A study to test the cannabinoid in other clinical pain models is planned for later this year.
“We are excited by the therapeutic potential of cannabinoids in treating a wide variety of pain indications. The pain market is a significant opportunity for Pharmos especially now that two leading COX-2 inhibitors have been pulled due to safety concerns with those compounds,” said Dr Haim Aviv, chairman and CEO.