Javelin Pharmaceuticals has announced it has been selected to receive a $750,000 grant to advance clinical development of PMI-150 (intranasal ketamine) for pain control. The grant, awarded through the Small Business Innovation Research (SBIR) program of the National Cancer Institute of the NIH, will support safety and efficacy studies of PMI-150 in a multicenter, randomized, double blind, placebo-controlled clinical trial in patients suffering from episodic acute moderate-to-severe pain.
With its earlier Phase I SBIR grant, Javelin conducted a successful pilot study of intranasal ketamine to control breakthrough pain in 20 patients. Results from this randomized, double-blind, placebo-controlled crossover study were published as a lead article in the peer-reviewed journal of the International Association for the Study of Pain. The pilot study established proof of principle for intranasal administration of ketamine for the treatment of episodic breakthrough pain in patients taking opioid analgesics for chronic pain.