Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the treatment of pain, today announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of top-line results from a Phase 2 study conducted by Covidien, of twice-daily administration of PENNSAID® Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel. The study met its primary endpoint of reducing osteoarthritis (OA) pain greater than a placebo vehicle control.
"We are pleased with the top-line results of this Phase 2 clinical trial for PENNSAID Viscous Solution," said Dr. Bradley S. Galer, President, Pain Group of Nuvo Research. "We look forward to receiving the detailed results from this study in the future and working with Covidien to obtain FDA approval for PENNSAID Viscous Solution."
The Phase 2 study was a four-week, two-arm, double-blind, vehicle-controlled, parallel, randomized trial. The primary endpoint was the effect of PENNSAID Viscous Solution vs. placebo vehicle control on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) pain from baseline to four weeks. The study enrolled 259 subjects who were either administered PENNSAID Viscous Solution or a placebo vehicle control for the duration of the study. There were no significant differences in subject retention, demographics or baseline characteristics between the two study arms. The most common adverse event in both groups was application site dryness (21.5% and 21.7%).
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