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Javelin Pharmaceuticals Announces Successful Pivotal Phase 3 Trial,Data

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 19, 2007 - Javelin Pharmaceuticals (AMEX: JAV) announced today that its product candidate Rylomine(TM) (intranasal morphine) successfully met its primary clinical endpoint, the Sum of the Pain Intensity Difference (SPID) scores over 0-24 hours postoperatively. In this first of two pivotal Phase 3 studies, patients with moderate-to-severe pain after elective orthopedic surgery were given 7.5 mg Rylomine every hour as needed, 15 mg Rylomine every 3 hours as needed, or 7.5 mg intravenous (IV) morphine every 3 hours as needed. Patients in each of the three active treatment groups had significantly better (p less than .01 or less) SPID scores over 24 hours than the corresponding placebo groups.

"Parenteral morphine is the gold standard for postoperative analgesia," commented Dr. Daniel B. Carr, CEO and CMO of Javelin Pharmaceuticals. "Today's gratifying results extend our prior positive study findings showing that Rylomine is a simple, effective alternative to more complex, cumbersome and costly methods of postoperative opioid analgesia. We look forward to continuing the development of this innovative product candidate."

There were no serious adverse events related to the study drug. Local adverse events associated with nasal administration (bad taste, throat irritation, instillation site reaction, nasal erythema, nasal irritation) were more common with Rylomine or intranasal placebo than the intravenous morphine groups. General systemic adverse events related to active drug were similar across morphine treatment groups regardless of route of administration and consistent with morphine's known pharmacologic effects (dizziness, nausea, transient decreased oxygen saturation, and vomiting).

Full analyses of the data are ongoing and will be reported when available.

About the Study

This study, termed MOR-003, involved 278 randomized patients with moderate
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