Javelin Pharmaceuticals’s Phase 2B Study Successful: Final Analysis Demonstrates Low Doses Of Dyloject(TM) Rapidly Relieve Postoperative Pain

ISTANBUL--(BUSINESS WIRE)--Sept. 14, 2006--Javelin Pharmaceuticals, Inc. (Amex: JAV - News) today presented final results of its US Phase 2B study of Dyloject(TM), a proprietary formulation of diclofenac for injection, tested in 353 patients with moderate-to-severe postsurgical pain. In addition to meeting the primary endpoint of a linear dose-response for pain relief over 6 hours, the study demonstrated that each of the five doses tested (3.75 through 75 mg) separated statistically from placebo. Dyloject's minimally effective dose for pain relief was 3.75 mg - one twentieth the standard dose Voltarol(R), the injectable diclofenac formulation currently marketed in the EU but not in US. This new study showed Dyloject's analgesic effect occurred as early as 5 minutes post-injection, extending a prior study that found Dyloject gave pain relief more quickly than Voltarol. These results were presented today at "Europe Against Pain", the 5th Congress of the European Federation of IASP Chapters (EFIC) held this year in Istanbul. IASP is the International Association for the Study of Pain, the largest organization worldwide of pain researchers and clinicians.
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