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The Ketotransdel(TM) Phase 3 registration study entitled: "A Randomized,Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Studyto Assess the Efficacy and Safety of Ketotransdel(TM) in the Treatment of PainAssociated with Mild to Moderate Acute Soft Tissue Injury," will be conductedat approximately 25 to 35 sites in the United States and potentially inCanada. The Company expects to enroll approximately 350 patients of which 50%will be provided Ketotransdel(TM) and 50% a placebo vehicle. The Phase 3study currently has three sites that are actively screening for patients. Itis expected that the majority of the sites will be activated during Octoberand November. The Company expects to report top-line results in the secondhalf of 2009.
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In the Phase 3 study, the primary efficacy endpoint will be the differencein the change of baseline pain between Ketotransdel(TM) and placebo at Day 3.This endpoint is measured by using the Visual Analogue Scale (VAS), avalidated and widely used scale for recording pain which 0 indicates "no pain"and 100 indicates "the worst imaginable pain." The secondary endpoints willinclude safety assessments and other efficacy parameters measured by VAS atDay 3 and Day 7. In addition to evaluating for efficacy and safety over theone week period, the study will also assess safety at one week post-treatment.
"We are excited about reaching this important milestone, the dosing of ourfirst patient. Along with our strategic partner and contract researchorganization, Cato Research Ltd., we continue to be extremely focused onenrolling appropriate patients and initiating new sites to meet our corporategoals," stated Dr. Juliet Singh, President and Chief Executive Officer ofTransdel Pharmaceuticals. "Ketotransdel(TM) could address a significant unmetmedical need for patients and physicians seeking a potentially safer effectivepain alternative to existing pain management approaches, such as oral NSAIDs.We are committed to aggressively advancing this program to fulfill this unmetmedical need."
Ketotransdel(TM) which consists of an elegant cream formulation isdesigned to be applied directly to the site of the pain. It is absorbedwithin minutes and is not associated with the limitations of patches.Musculoskeletal pain conditions are defined as pain that affects the muscles,ligaments and tendons. If approved, Ketotransdel(TM) could be the firsttopical cream in the United States for treatment of acute pain related tomusculoskeletal conditions.
Industry estimates indicate that the market for NSAIDs and Cox-2inhibitors exceeds $6 billion per year and that more than 30 million peopleworldwide use NSAIDs daily. Due to the recognition of known risks associatedwith orally administered NSAIDs, including cardiovascular, gastrointestinaland other medical complications, and the decline in the use of Cox-2inhibitors due to safety concerns, the Company believes that there is asignificant demand for topical pain management products such asKetotransdel(TM).
If and when the FDA approves Ketotransdel(TM) for treatment of acute pain,the Company intends to pursue FDA approval of Ketotransdel(TM) for otherindications, such as osteoarthritis. The Company believes that the clinicalsuccess of Ketotransdel(TM) will facilitate the use of the Transdel(TM)delivery technology, which is utilized i
