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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