Javelin Initiates Dosing in Phase III Acute Pain Trial
Posted on: Wednesday, 11 June 2008, 09:01 CDT
Javelin Pharmaceuticals has announced dosing of the first patient in its pivotal Phase III clinical study of PMI-150 for acute pain.
The trial is expected to enroll approximately 200 patients and is designed to confirm the analgesic efficacy of PMI-150 in treating postoperative pain following orthopedic surgery.
Prior randomized, double-blind, placebo-controlled, Phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate-to-severe postoperative and breakthrough pain, the company said.
The primary measure of efficacy is the sum of the differences from initial pain intensity as measured on a 0-100mm visual analog scale over six hours.
Daniel Carr, president and chief marketing officer of Javelin, said: "This pivotal Phase III efficacy study is a multi-dose efficacy study to support the new drug application (NDA) for PMI-150 in the US. We are pleased to start this key trial and plan to expedite the study by quickly increasing the number of clinical sites, so that we can file a high-quality NDA with the FDA next year."
Source: Datamonitor
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