Healthcare Industry News:  analgesia 

Biopharmaceuticals

 News Release - May 23, 2006

Javelin Enrolls First Patient in Pivotal Phase III Study of Rylomine(TM)

CAMBRIDGE, Mass., May 23 (HSMN NewsFeed) -- Javelin Pharmaceuticals, Inc. (OTC Bulletin Board: JVPH ), a developer of innovative prescription pain medications, today announced it has treated the first patient in a Phase III clinical study of Rylomine(TM), the Company's proprietary intranasal formulation of morphine. This pivotal US study will enroll 256 patients with moderate-to-severe postoperative orthopedic pain.

This study follows Javelin's successful completion of a 187-patient Phase IIb study in patients with acute postoperative pain, and the Company's successful end-of-Phase II meeting with the FDA. Results of this Phase IIb study were presented at annual meetings of the American Academy of Pain Medicine in February, 2006 and the American Pain Society in May, 2006. These results showed that Rylomine(TM) provided postsurgical patients with clinically and statistically significant relief of postoperative orthopedic pain, similar to intravenous morphine.

About the Study

A total of 256 postoperative elective orthopedic surgical patients from the United States will be randomized in this multi-center, double-blind, placebo- and comparator-controlled study, to receive one of two dosing regimens of Rylomine(TM), intravenous (IV) morphine, or placebo. Patients with moderate-to-severe pain following elective orthopedic surgery will eligible for treatment over 24 hours. The primary measure of efficacy is the Sum of the Pain Intensity Differences (SPID) over 24 hours as measured on the 0-100 mm Visual Analog Scale (VAS). In this blinded study, patients will receive treatments whose identity will not be known to either them or the investigator.

About Rylomine(TM)

Rylomine(TM) is a patient-controlled nasal spray that delivers a single, metered dose of morphine, an opioid analgesic used for the treatment of moderate-to-severe pain. After use, a negligible amount of morphine remains in the dispenser, avoiding the risk of scavenging and abuse of discarded devices. Data from clinical studies have demonstrated that Rylomine(TM) has similar efficacy to intravenous morphine.

Parenteral morphine is the standard of care for management of acute moderate-to-severe pain, especially in the postsurgical setting where analgesic requirements vary between individuals and may fluctuate even in the same patient. IV morphine analgesia has rapid onset, excellent efficacy, can accommodate variations in analgesic demand, and has risks that are well understood by medical personnel. Morphine, like many drugs, is poorly absorbed across mucosal barriers and, in particular, the nasal membrane. Javelin's proprietary technology allows for nasal delivery of predictable therapeutic blood levels of morphine. The key to this technology is ChiSys(TM), a carbohydrate polymer that, while pharmaceutically inert by itself, enhances the absorption of compounds across mucosal membranes, such as those found in the nasal cavity. The contribution of ChiSys(TM) to enhancing mucosal drug absorption reflects several factors including its potent mucoadhesive property, which prevents drug washout. Rylomine(TM) is a novel formulation of morphine and ChiSys(TM) packaged in a single unit-dose nasal spray. Worldwide, no comparable formulation of morphine is available.

About Javelin

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. For additional information, please visit the 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

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.