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TheraQuest Presents Postsurgical Pain Results at the American Pain Society Meeting in Boston
TheraQuest Biosciences, a development stage pain management company, today unveiled new, positive Phase II clinical trial results for its intravenous ketoprofen (TQ-1011) product at the American Pain Society 24th Annual Scientific Meeting in Boston.
TQ-1011 is a proprietary investigational injectable formulation of the non-steroidal anti-inflammatory drug (NSAID) ketoprofen. Injectable ketoprofen is being developed for the management of moderate to severe postsurgical pain. TheraQuest has held regulatory consultations with FDA, U.K. and Canadian authorities.
Najib Babul, PharmD, President and Chief Executive Officer of TheraQuest, stated, "TheraQuest is excited about the positive Phase II results from this large, double blind study in moderate to severe postsurgical pain. Intravenous ketoprofen was superior to placebo and IV morphine on all standard efficacy endpoints."
Paul Desjardins, DMD, PhD, Executive Vice President of SCIREX, a premier analgesic CRO that conducted this clinical trial, noted, "The results are striking because both doses of IV ketoprofen provided rapid onset of effect and robust, long lasting analgesia, superior to morphine and placebo. In particular, on the patient global assessment of therapy, approximately 90% of patients receiving IV ketoprofen reported 'Excellent,' 'Very Good' or 'Good' analgesia versus only 15% on morphine 4 mg IV and 3% on placebo."
About the Trial Results
One hundred and thirty patients participated in this double blind, randomized clinical trial comparing the analgesic efficacy and safety of IV doses of ketoprofen 50 and 100 mg, with morphine sulfate 4 mg and placebo, in patients with moderate to severe postsurgical pain after third molar surgery. The study used the standard analgesic design recommended by FDA for testing analgesics for acute pain. Both doses of IV ketoprofen provided rapid onset of effect and excellent pain relief. On every pain measure, including onset of relief, peak relief, duration of relief, time to rescue and patient global assessment of therapy, ketoprofen 50 mg and 100 mg IV were superior to IV morphine 4 mg and placebo (p<0.001). Both doses of ketoprofen were well tolerated.