Javelin Pharmaceuticals' Latest Study of Dyloject Confirms Minimal Effect on Platelet Function, Differentiating Dyloject from Ketorolac and Aspirin
"These results are consistent with our earlier observations of less surgical site bleeding with Dyloject than ketorolac at clinically pertinent doses," said Dr. Carr. "This commercially relevant data further demonstrates what we believe are the comparative advantages of Dyloject over ketorolac, the only approved injectable NSAID in the US market."
About the Study
In this single center, open-label, crossover study, 30 normal healthy male volunteers were randomized to receive a single bolus intravenous injection of Dyloject(TM) 75 mg, an oral dose of Cataflam 50 mg, an intravenous dose of ketorolac tromethamine 30 mg, and an oral dose of aspirin 325 mg. In this "unblinded" study, patients received all four identical treatments the identity of which was known by the investigator and the patient.
Platelet function was assessed at multiple time points up to 24 hours following exposure to each of the test drugs. The primary observations were the times (in seconds) to formation of a platelet plug upon exposure to either collagen+ADP or collagen+epinephrine, as measured in standard fashion using the PFA-100 platelet analyzer.
The study demonstrated marked, prolonged alterations in platelet function after both ketorolac and aspirin, with highly statistically significant alterations in PFA-100 results noted for both collagen+epinephrine and collagen+ADP induced aggregation. In contrast, the effects of Dyloject and Cataflam, although discernible, achieved a maximum magnitude comparable to the upper range of normal.
There were no serious or significant adverse events and the most common side effects reported, regardless of treatment group, were flatulence (13%), and headache ( <1%). These side effects were comparable across treatment arms and consistent with established safety data worldwide for the active ingredient, diclofenac.
Full results of the study will be reported at an upcoming scientific meeting.
Dyloject(TM) is an injectable NSAID with analgesic, anti-inflammatory and antipyretic activity. Diclofenac, the same active ingredient in Dyloject(TM), Voltaren(R), Cataflam(R) and Voltarol(R), is a leading analgesic for the treatment of moderate-to-severe postsurgical pain and has a demonstrated history of efficacy and safety since its approval in 1981. Historically, diclofenac has been used to treat pain from inflammatory and degenerative forms of osteoarthritis, musculoskeletal conditions, acute attacks of gout, kidney stones, and after surgical operations or trauma.
Dyloject recently received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is now being sold. In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the latter product 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 potential to save the UK NHS up to GBP 50 per postoperative patient compared to the currently marketed formulation. This pharmacoeconomic benefit coupled with Dyloject's superior clinical attributes differentiates Dyloject from the currently marketed IV formulation of diclofenac sodium. Today's results further differentiate Dyloject from ketorolac, the only injectable NSAID available for use in the US.
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.
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.
Rick Pierce, 617-349-4500
VP Investor Relations
Posted: January 2008