News: Javelin Pharmaceuticals' Dyloject Accepted by Scottish …
Today Javelin Pharmaceuticals Inc. (AMEX: JAV) announced that
Dyloject(R) (diclofenac sodium solution for injection) has been
accepted by the Scottish Medicines Consortium (SMC) for use within the
National Health Service (NHS) Scotland, for the treatment or
prevention of postoperative pain by intravenous injection, in
supervised healthcare settings at the NHS Tariff Price of GBP 48 per
pack (10 x 75mg/2ml vials).
“This is a significant decision” said Derek Gallacher, European
Managing Director for Javelin. “Not only is Javelin now able to
commercialize Dyloject in Scotland which represents approximately
eight percent of the UK market, but the SMC assessment is viewed
extremely favorably by other Health Technology assessment bodies
throughout Europe. Achieving a positive SMC assessment speaks to the
strong clinical profile and cost-saving benefits Dyloject brings to
the treatment or prevention of postoperative pain.”
“The opioid sparing effect of Dyloject, coupled with the ease of
simple IV bolus delivery represents a major contribution to the
multimodal management of acute postoperative pain. It will be a very
useful addition to our postoperative drug portfolio in Scotland” said
Dr. Graeme McLeod, Consultant Anaesthetist at Ninewells Hospital,
Dundee, Scotland.
Dyloject is being marketed by Javelin’s UK sales force in a
convenient ready-to-use injectable formulation that can be
administered quickly as an IV bolus at considerable cost savings (up
to GBP 50 per treated patient) compared to the current branded
diclofenac formulation that requires buffering, dilution and slow
infusion over at least 30 minutes.
About The Scottish Medicines Consortium and Its Advice for
Dyloject
The SMC provides advice to NHS Boards and their Area Drug and
Therapeutics Committees (ADTCs) across Scotland about the status of
newly licensed medicines, new formulations of existing medicines,
and new indications for established products. Favorable SMC advice
facilitates the introduction of beneficial treatments like Dyloject
throughout Scotland.
The SMC advice is as follows:
“following a full submission diclofenac (Dyloject) is accepted for
restricted use within NHS Scotland for the treatment or prevention of
post-operative pain by intravenous injection, in supervised healthcare
settings.
When given as an intravenous bolus, it showed non-inferiority to a
comparator non-steroidal anti-inflammatory drug infusion at providing
pain relief over an initial 4 hour period and caused less
thrombophlebitis.
The manufacturer’s submission related only to intravenous use of
diclofenac (Dyloject) in the post-operative setting. SMC cannot
recommend its use by the intramuscular route.”
About Dyloject
Dyloject is an injectable NSAID with analgesic, anti-inflammatory
and antipyretic activity. Diclofenac, the same active ingredient in
Dyloject, 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.
In October of 2007, Dyloject received Marketing Authorization
Application (MAA) approval and favorable pricing in the UK, where it
is also 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.
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.
JAV-G
