Acute Post-Operative Pain - Javelin Enrolls First Patient In An Open Label Safety Study Of Dyloject

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Sep 2008 - 8:00 PDT

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Javelin Pharmaceuticals, Inc. (Amex: JAV), a leading developer of novel products for pain management, today announced that it had enrolled the first patient in a planned Phase 3, single-arm, open label observational safety study for its injectable NSAID, Dyloject™ (diclofenac sodium). The study is intended to supplement the Company's summary of integrated patient safety data base, a part of its New Drug Application (NDA) for Dyloject in the United States, planned for submission to the FDA in 2009.

"We anticipate utilizing 80 clinical sites to expedite completion of this study and look forward to submitting an NDA for acute postoperative pain in the United States in 2009.The single-arm, open-label design of this safety study allows more rapid enrollment and data monitoring than our two double-blinded, pivotal Phase 3 efficacy studies. In addition to our US clinical results for Dyloject to date, we are pleased by our post-marketing experience with Dyloject, since its UK launch in December 2007." said Daniel Carr, M.D., Javelin's Chief Medical Officer & President.

The initiation of this single-arm open label observational safety study follows a successful pivotal Phase 3 study of Dyloject™ in patients with postoperative abdominal pain. Additionally, the Company plans to report top-line data later this year from a second pivotal Phase 3 study, evaluating Dyloject in patients with postoperative orthopedic pain.

About the Study

The study will enroll up to 700 male and female patients from age 18-85 in an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of Dyloject in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive Dyloject 37.5 mg IV bolus q6 hours (patients weighing ≥ 95 kg will receive 50 mg IV bolus q6 hours; patients with mild renal insufficiency or mild hepatic dysfunction will receive 18.75 mg IV bolus q6 hours). Safety assessments will be collected at baseline (immediately prior to starting Dyloject therapy) and at study discharge or early termination. Patient global assessment will be obtained at study discharge or early termination. Patients will receive Dyloject for a minimum of 48 hours and until they are transitioned to oral analgesics, discharged from the institution, received a maximum of five days of treatment with Dyloject or discontinued from the study which ever comes first.

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 from the competitive diclofenac product, as well as from any of the other marketed IV NSAID products. 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 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.