TheraQuest Presents Postsurgical Pain Results at the American Pain Society Meeting in Boston

BLUE BELL, Pa., March 30 /PRNewswire/ — 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. Full details of the American Pain Society scientific poster presentation may be found at http://www.theraquestinc.com/.

About Injectable Analgesics

Opioids are frequently used as injectable analgesics for the management of postsurgical pain. While effective, they can produce a number of common side effects, including nausea, vomiting, drowsiness and constipation. In addition, they have the potential to cause respiratory depression and cardiac arrest.

The only injectable NSAID approved by the FDA, 15 years ago, is ketorolac. However, the clinical utility of ketorolac is limited due to its side effect profile and a short duration of action. In a number of countries including France and Germany, injectable ketorolac has been removed from the market for safety reasons. Parecoxib, an injectable COX-2 inhibitor, is currently under investigation for postsurgical pain. However, recent studies of parecoxib after surgery report more frequent serious cardiovascular events with short- term parecoxib and valdecoxib than with placebo (2.0% vs. 0.5%, P=0.03). In addition, parecoxib-valdecoxib treatment has been associated with significantly more sternal wound infections than control patients (3.2% vs. 0%, P=0.035). Thus, there is a need for alternative parenteral analgesics for the treatment of acute postsurgical pain. [Parecoxib references: N Engl J Med 2005;352:1081-91 & J Thorac Cardiovasc Surg 2003;125:1481-92.].

About TheraQuest

TheraQuest Biosciences, LLC is a private, development-stage pain management company building a diversified portfolio of pharmaceutical products to address a critical area of unmet medical need. Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $25 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest’s strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.

TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania. Additional information is available at http://www.theraquestinc.com/.

TheraQuest Biosciences, LLC

CONTACT: Najib Babul, PharmD, CEO, TheraQuest Biosciences, LLC,+1-610-272-2071, inquiry@theraquestinc.com

Web site: http://www.theraquestinc.com/