Javelin
Pharmaceuticals, Inc. (OTC Bulletin Board: JVPH), a developer of innovative
prescription pain medications, today announced treatment of the first
patient in its Phase III clinical program for its injectable NSAID,
Dyloject(TM) (diclofenac sodium). This pivotal US study will enroll 360
patients with moderate-to-severe postoperative pain following abdominal
surgery. A second pivotal US study in a different postoperative pain model
(orthopedic surgery) is planned to begin later this year.
"Javelin has now commenced enrollment in Phase III programs for two of
its three product candidates this month," said Dr. Daniel Carr, the
Company's Chief Executive Officer and Chief Medical Officer. "As with our
other Phase III program for the intranasal morphine product Rylomine(TM),
in both cases a productive end-of-Phase II meeting with the FDA allowed us
to define a straightforward path to regulatory approval. Javelin's
development team has been highly effective in bringing these two product
candidates into Phase III clinical testing nearly simultaneously."
This study follows the successful completion of a 353 patient Phase IIb
study of Dyloject(TM) in patients with postoperative pain. Javelin's Phase
II studies of this nonselective NSAID showed it to be well tolerated, with
a quicker onset, equal duration of effect, and less associated phlebitis
than Voltarol(TM), the injectable diclofenac formulation currently marketed
in Europe. An application to market Dyloject(TM) was filed last fall in
Europe. Results of the latest Phase IIb study have been submitted for
presentation at the annual meeting of the European Federation of IASP
Chapters in September 2006.
About the Study
A total of 360 lower abdominal surgery patients from the United States
will be randomized in this multi-center, double-blind, placebo- and
comparator-controlled study, to receive either one of two doses of
Dyloject(TM) (18.75 or 37.5 mg IV q6H), IV ketorolac 30 mg every six hours,
or placebo. Patients with moderate-to-severe pain following lower abdominal
surgery will be eligible for treatment in this study. The primary measure
of efficacy is the Sum of the Pain Intensity Difference (SPID) over 48
hours as measured on the 0-100 mm Visual Analog Scale (VAS).
About Dyloject(TM)
Dyloject(TM), an injectable nonsteroidal anti-inflammatory drug (NSAID)
has analgesic, anti-inflammatory and anti-pyretic activity. Diclofenac, the
same active ingredient in Dyloject(TM), Voltaren(R), Cataflam(R), and
Voltarol(R), is a leading analgesic for the treatment of acute and chronic
pain, and has a demonstrated history of efficacy and safety since its
approval in 1981. The safety of short-term use of diclofenac, which is a
nonselective NSAID and not a selective COX-2 inhibitor, has been reaffirmed
in recent white papers issued in 2005 by European and U.S. regulatory
agencies. 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 operations or
trauma. Currently, the only injectable form of diclofenac in Europe and
other parts of the world is Voltarol(R). Voltarol(R) requires a slow (30
minutes or longer) infusion of a solution that is freshly prepared for each
patient and is not available in the United States. Dyloject(TM) is a new
Javelin formulation utilizing the same active ingredient as Voltarol(R),
but is given as a single, brief injection. Worldwide, no comparable
formulation of diclofenac has been available previously.
About Javelin
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. For additional information, please
visit the website at javelinpharmaceuticals.
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.
javelinpharmaceuticals