Javelin Presents Successful Pivotal Phase 3 Secondary Clinical Results for Dyloject at the 12th World Congress on Pain
GLASGOW, Scotland--(BUSINESS WIRE)--Aug. 21, 2008 - Javelin Pharmaceuticals, Inc. (Amex: JAV), a leading developer of novel products for pain management, today presented new and successful secondary endpoint data from a previously announced pivotal Phase 3 study of Dyloject(TM). At the 12th World Congress on Pain, held in Glasgow, Scotland. Dyloject was launched in the United Kingdom in December of last year and this year received Scottish Medicines Consortium approval.
The newly-released secondary endpoint data extends clinical evidence that intravenous (IV) Dyloject offers safe, efficacious and well-tolerated pain relief for abdominal and pelvic surgery. Patient global evaluation scores and related measures of efficacy at 24 and 48 hours were statistically significantly higher than placebo for all three arms of the study: Dyloject 18.75 mg and 37.5 mg and the active comparator ketorolac 30 mg. Compared to the ketorolac group, the Dyloject groups had a lower incidence of thrombophlebitis, and numerically fewer adverse events associated with postoperative bleeding.
Javelin's Chief Medical Officer, Dr. Daniel B. Carr, and colleagues made four additional presentations. Dyloject given IV in clinically relevant analgesic doses to healthy volunteers in a Phase 1 study produced minimal interference with platelet function (ability to clot), reaching only the upper limit of normal. Similar small effects were seen with an oral diclofenac comparator, Cataflam(R). In contrast, IV ketorolac and oral aspirin markedly disrupted platelet function as measured by PFA-100 collagen-epinephrine closure time. Similar findings were observed with collagen-ADP testing. The Phase 1 and pivotal Phase 3 results presented today add to prior pre-marketing and early post-marketing experience that Dyloject, a balanced COX-1 and COX-2 inhibitor, poses less risk of bleeding than predominantly COX-1 inhibitors such as ketorolac and aspirin.
Two additional presentations at the World Congress focused on Rylomine(TM) and another featured Ereska(TM), respectively, Javelin's intranasal morphine and ketamine product candidates.
"We are very pleased to have had five Javelin posters accepted for presentation at this prestigious World Congress on Pain meeting. Especially timely are the presentations on Dyloject demonstrating its safety, rapid efficacy, and convenience of use as it nears its ninth month of marketing in the UK and, more recently, Scotland. We had enthusiastic physician turnout at our Congress booth and presentations. It's been a very positive week for Dyloject and Javelin," stated Dr. Carr.
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.
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.
Posted: August 2008