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Javelin Pharmaceuticals, Inc. announced dosing of the first patient in its pivotal Phase 3 clinical study of PMI-150 (intranasal ketamine) for acute pain
CAMBRIDGE, MA, USA | Jun 10, 2008 | Javelin Pharmaceuticals, Inc. (AMEX: JAV) announced dosing of the first patient in its pivotal Phase 3 clinical study of PMI-150 (intranasal ketamine) for acute pain. The trial is expected to enroll approximately 200 patients and is designed to confirm the analgesic efficacy of PMI-150 in treating postoperative pain following orthopedic surgery. Prior randomized, double-blind, placebo-controlled, phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate-to-severe postoperative and breakthrough pain.
"This pivotal Phase 3 efficacy study is a multi-dose efficacy study to support the New Drug Application (NDA) for PMI-150 in the US," said President and CMO, Dr. Daniel Carr. "We are pleased to start this key trial and plan to expedite the study by quickly increasing the number of clinical sites, so that we can file a high quality NDA with the FDA next year."
About the Trial
Approximately 200 patients from the United States with postoperative pain following orthopedic surgery are planned to be randomized in this multicenter, double-blind, parallel, placebo-controlled study. Patients will receive study drug treatment (double-blinded PMI-150 or placebo, whose identity will not be known to either them or the investigator) starting when they experience moderate-to-severe pain in the immediate postoperative period. The primary measure of efficacy is the sum of the differences from initial pain intensity as measured on a 0-100 mm visual analog scale over 6 hours.
About PMI-150 (Intranasal Ketamine)
The Company is developing PMI-150, a proprietary nasal formulation of ketamine, for several intended indications. One indication, which this clinical efficacy trial will support, is as an analgesic for acute pain. The Company is presently undertaking additional clinical studies aimed to support additional indications such as breakthrough pain due to cancer. Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of moderate-to-severe pain.
Prior randomized, double-blind, placebo-controlled, phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate-to-severe postoperative and breakthrough pain. These study results have been published in peer-reviewed journals (Carr et al, Pain 2004; 108: 17-27; and Christensen et al, Acute Pain 2007; 9: 183-192), and presented at meetings of the American Society for Clinical Pharmacology and Therapeutics, the American Society of Clinical Oncology, and in a plenary session of the Advanced Technology Application for Combat Casualty Care. Following this last presentation, the U.S. Department of Defense awarded the Company approximately $4.3 million in funding extensions to develop PMI-150. This award reflected the need for a fast-acting, noninvasive, and non-sedating alternative to the intravenous and oral medications commonly used for treatment of combat-related injuries.
About Ketamine
Ketamine, a non-opiate, is an N-methyl-D-aspartate (NMDA) receptor antagonist that has been in clinical use for over 30 years. Since its approval by the FDA, ketamine has been safely used as an anesthetic in tens of thousands of patients. NMDA receptors are located in the central nervous system and play a role in the perception of acute and chronic pain. Ketamine, at lower doses than those approved for anesthetic use, has been recognized in the medical literature to be an effective analgesic for postoperative pain, nerve injury pain, breakthrough episodes of pain such as from cancer, and pain during medical procedures such as burn dressing changes.
About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has three drug candidates in US Phase 3 clinical development. One of these US Phase 3 drug candidates, Dyloject(TM), has received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is now being sold. Previous clinical trials have demonstrated its safety and rapid onset of action. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com.
SOURCE: Javelin Pharmaceuticals, Inc. |
