DDS-T NR today 43m at 8.42
Labopharm gets significant statistics in tramadol trial
2006-04-12 07:17 ET - News Release
Mr. James Howard-Tripp reports
LABOPHARM REPORTS POSITIVE RESULTS FOR PHASE III STUDY ON ONCE-DAILY TRAMADOL - RESULTS TO BE ADDED TO NDA WITH PDUFA DATE OF SEPTEMBER 28, 2006
Labopharm Inc.'s recently completed multicentre phase III clinical trial (MDT3-005) for its once-daily formulation of tramadol achieved statistical significance for the primary end point.
"We are extremely pleased with these results. This data enhances our NDA currently being reviewed by the Food and Drug Administration," said James R. Howard-Tripp, president and chief executive officer, Labopharm.
The results of the study will be added to the company's new drug application (NDA) for once-daily tramadol in the United States, which is currently under review by the Food and Drug Administration (FDA). Based on discussions with the FDA, the company plans to submit the data on a timely basis such that the action date under the Prescription Drug User Fee Act (PDUFA) remains Sept. 28, 2006.
Results of the study
The randomized, double-blind, multicentre parallel study conducted under a special protocol assessment with the FDA, compared the safety and efficacy of Labopharm's once-daily formulation of tramadol to placebo over a 12-week period. Enrolment in the trial consisted of patients diagnosed with moderate to severe pain associated with osteoarthritis of the knee. Patients were randomized to treatment with Labopharm's once-daily tramadol or placebo and underwent double-blind titration to an optimal dose of either 200 or 300 milligrams. The optimal dose for each patient, which was maintained for a period of 12 weeks, was selected based on the effectiveness of pain relief and the tolerability of adverse events. Approximately 1,000 patients were enrolled in this trial.
The primary end point of the study was to compare baseline pain intensity with pain intensity at the end of the study period as measured by the 11-point pain intensity numerical rating score (PI-NRS) in the once-daily tramadol group versus the placebo group. Statistical significance was achieved for the primary end point (p value of 0.0157) and was maintained under additional methods of analysis. The dropout rate was comparable with that of the company's European phase III trial (MDT3-001). The incidence of adverse events was lower than in study MDT3-001, and similar to the previous two United States phase III clinical trials (MDT3-002 and MDT3-003).
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