Javelin Pharmaceuticals Wins Phase II SBIR Grant
Javelin Pharmaceuticals, Inc. (OTC Bulletin Board: JVPH), a specialty pharmaceutical company with three late-stage pain drug candidates, today announced it has been selected to receive a seven hundred and fifty thousand dollar 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/National Institutes of Health (NCI/NIH), will support safety and efficacy studies of PMI-150 in a multi-center, randomized, double blind, placebo-controlled clinical trial in patients suffering from episodic acute moderate-to-severe pain.
"Javelin is honored by our success in this highly competitive grant process from such a prestigious source," said Dr. Daniel Carr, Chief Executive Officer and Chief Medical Officer. "The rigorous, peer-reviewed evaluation that resulted in the NCI and NIH acknowledgment of the merit of PMI-150, although entirely distinct from our Department of Defense funding, is the third validation from a federal funding source for this drug candidate. The Phase I SBIR, Department of Defense, and now Phase II SBIR reviewers share our view that intranasal ketamine can provide a useful alternative to opioids such as morphine for pain relief."
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, published as a lead article in the peer-reviewed journal of the International Association for the Study of Pain (Pain 2004; 108: 17-27), attracted worldwide attention, including citation in the World Health Organization's bulletin, "Cancer Pain Release." 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.