750K Funding Provides Additional NCI/NIH Support for Javelin's Intranasal Ketamine Development
CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Javelin Pharmaceuticals, Inc. (OTC Bulletin Board: JVPH - News), 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.
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 two drug candidates in Phase III clinical development. One of these, Dyloject(TM), is currently under review for Marketing Authorization Application (MAA) approval in Europe. Previous clinical trials have demonstrated its safety along with rapid onset of action. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Source: Javelin Pharmaceuticals, Inc.
Safety and efficacy of intranasal ketamine for the treatment of breakthrough pain in patients with chronic pain: a randomized, double-blind, placebo-controlled, crossover study
Daniel B. Carr, a, b, Leonidas C. Goudasa, William T. Denmana, Daniel Brookoffc, Peter S. Staatsd, Loralie Brennena, Geoff Greene, Randi Albine, Douglas Hamiltone, Mark C. Rogerse, Leonard Firestonee, Philip T. Lavinf and Fred Mermelstein, e
a Department of Anesthesia, Box 298, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111, USA
b Department of Medicine, Tufts-New England Medical Center, Boston, MA 02111, USA
c Methodist Comprehensive Pain Institute, Methodist Hospital, Memphis, TN 38104, USA
d Johns Hopkins Hospital, Baltimore, MD 21205, USA
e Innovative Drug Delivery Systems (IDDS), Inc., 787 Seventh Avenue, New York, NY 10019, USA
f Averion, Inc., 4 California Avenue, Framingham, MA 01701, USA
Received 19 March 2003; Revised 23 June 2003; accepted 1 October 2003. Available online 20 April 2004.
Few placebo-controlled trials have investigated the treatment of breakthrough pain (BTP) in patients with chronic pain. We evaluated the efficacy and safety of intranasal ketamine for BTP in a randomized, double-blind, placebo-controlled, crossover trial. Twenty patients with chronic pain and at least two spontaneous BTP episodes daily self-administered up to five doses of intranasal ketamine or placebo at the onset of a spontaneous BTP episode (pain intensity ≥5 on a 0–10 scale). Two BTP episodes at least 48 h apart were treated with either ketamine or placebo. Patients reported significantly lower BTP intensity following intranasal ketamine than after placebo (P<0.0001), with pain relief within 10 min of dosing and lasting for up to 60 min. No patient in the ketamine group required his/her usual rescue medication to treat the BTP episode, while seven out of 20 (35%) patients in placebo group did (P=0.0135). Intranasal ketamine was well tolerated with no serious adverse events. After ketamine administration, four patients reported a transient change in taste, one patient reported rhinorrhea, one patient reported nasal passage irritation, and two patients experienced transient elevation in blood pressure. A side effect questionnaire administered 60 min and 24 h after drug or placebo administration elicited no reports of auditory or visual hallucinations. These data suggest that intranasal administration of ketamine provides rapid, safe and effective relief for BTP.
Author Keywords: Ketamine; Intranasal; Pain; Chronic; Breakthrough; Randomized controlled trial
Corresponding Author Address: Department of Anesthesia, Box 298, Tufts-New England Medical Center, 750 Washington Street, Boston, MA 02111, USA. Tel.: +1-617-636-9710; fax: +1-617-636-9709
Volume 108, Issues 1-2, March 2004, Pages 17-27