News: Javelin Presents Successful Pivotal Phase 3 Secondary …
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.
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 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.
JAV-G
