Javelin Pharmaceuticals Completes Patient Enrollment For Second Of Two Pivotal Phase 3 Studies Of Dyloject(TM)

Main Category: Pain / Anesthetics
Also Included In: Bones / Orthopaedics;  Clinical Trials / Drug Trials
Article Date: 18 Sep 2008 - 4:00 PDT

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Javelin Pharmaceuticals (AMEX: JAV) announced that it has completed patient enrollment in the second of two US pivotal Phase 3 studies for its injectable pain drug, Dyloject(TM) (diclofenac sodium). This pivotal clinical study evaluated Dyloject in patients with moderate-to-severe postoperative pain following elective orthopedic surgery. A previously completed and successful US pivotal study evaluated Dyloject in patients suffering from moderate-to-severe postoperative pain after elective abdominal surgery. The Company is planning to file a New Drug Application for the treatment of acute postoperative pain in 2009.

Dyloject is being marketed in the UK and Javelin expects to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009.

About the Orthopedic Efficacy Study

A total of 242 postoperative elective orthopedic surgical patients completed this multicenter, placebo- and comparator-controlled study. They received one of three dose levels of Dyloject(TM) (18.75, 37.5 or 50 mg IV every six hours), one of two dose levels of IV ketorolac (15 or 30 mg every six hours), or IV placebo. Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to 5 days. The primary measure of efficacy was the Sum of Pain Intensity Differences (SPID) as measured on the 0-100 mm Visual Analog Scale (VAS). In this double-blinded study, patients received treatments whose identity was not known either to them or their investigators.

About Dyloject

Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the United States and Marketed in the United Kingdom. Diclofenac is a prescription nonsteroidal anti-inflammatory drug ("NSAID") that is widely prescribed to treat post-operative pain due to its combination of effectiveness and tolerability. Dyloject has the potential to provide an attractive alternative to other NSAIDs for the treatment of post-operative pain, and to decrease the need for morphine or other opioids in this setting. There still exists an underserved medical need for a safe and effective injectable NSAID in the hospital setting. In its pivotal UK registration trial, Dyloject's efficacy and safety were shown to be significantly superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the competitive formulation requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has the potential to save the UK NHS up to GBP 50 per postoperative patient. This pharmacoeconomic benefit, coupled with Dyloject's superior clinical attributes, differentiates Dyloject. Dyloject is presently being marketed in the UK for the treatment of acute moderate-to-severe pain. Subsequent submissions and approvals in other European countries are anticipated through a regulatory strategy following the Mutual Recognition Process.

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 one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. 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.

Javelin Pharmaceuticals, Inc.