NEW YORK (Thomson Financial) - Javelin Pharmaceuticals Friday said Dyloject,
a non-steroidal anti-inflammatory drug, met primary and secondary analgesic
efficacy endpoints in the first of two pivotal Phase III studies.
Endpoints in the postoperative abdominal surgery trial included differences
in pain intensity (SPID) versus pretreatment pain scores across one to two days.
Patients receiving Dyloject doses had "markedly better" SPID scores than the
placebo group, the company said, adding that previous trial results have shown
Dyloject to be more potent and quicker than diclofenac formulations.
"The ability to use lower doses of a non-steroidal anti-inflammatory drug
while achieving equal pain relief has important safety implications. Our new
pivotal trial confirms that doses of Dyloject 50% and 75% lower than the
standard dose of the prior diclofenac formulation achieved clinically meaningful
analgesia," the company said.
Javelin's second Phase III trial is currently underway and aims to extend
the abdominal surgery results to orthopedic surgery.
Shares of the Cambridge, Mass.-based developer of new and improved pain
management drugs closed Thursday at $4.40.
Melinda Peer
mp/tk1
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