The Zacks Small-Cap Profile include: Transdel Pharmaceuticals – Press Releases

On September 2, 2010, Transdel Pharmaceuticals (Nasdaq: TDLP) presented the full data from the company’s phase III program, TDLP-110-001, at the 13th World Congress on Pain. The trial enrolled 364 patients with acute soft tissue injuries (sprains & strains) randomized at 26 clinical sites in the U.S. Subjects received TDLP-110 (Ketoprofen 10% cream), called Ketotransdel, 1g 3x daily, or placebo, over a 7-day period.

The primary endpoint was the change from baseline in pain intensity as measured by the 100mm visual analog scale (VAS) during daily activities on the Day 3 visit. Other secondary endpoints included safety assessments, various efficacy variables, and stead-state pharmacokinetics (pk) analysis.

Results show that Ketotransdel treated patients had statistically significant greater reductions in pain intensity than placebo-treated patients. During the trial, Ketotransdel demonstrated excellent safety and tolerability, with no treatment related gastrointestinal, cardiac, liver or other serious adverse events. Pharmacokinetic analysis revealed no clinically relevant changes in blood and urine tests, and very low blood concentrations (mean Cmax) of ketoprofen following topical application when compared to comparable doses of oral ketoprofen.

The trial met the primary endpoint in reduction in pain intensity during daily activities over a 24-hour period on Day 3 visit (modified ITT population) using the 100mm VAS. Results show a 37.9% reduction in pain for patients on Ketotransdel vs. a 32.7% reduction for those on placebo (p=0.038). Patient satisfaction on achieving moderate to high pain relief, as measured by the 7 point Likert Scale, showed a statistically significant advantage on Day-3 (p=0.023) for the Ketotransdel treated group.

Also, pain relief assessment using the 5-item Pain Relief Scale (PRS-5) showed a statistically significant advantage on Day-7 (p=0.042) for the Ketotransdel treated group. Other secondary efficacy endpoints, including Time to Onset of Perceptible Pain Relief and Time to Onset of Meaningful Pain Relief, also demonstrated an advantage for the Ketotransdel group over placebo.

During the program, Ketotransdel demonstrated excellent safety and tolerability. The data below shows the adverse event rate for both Ketotransdel and the placebo. We note that there will half the number of cutaneous (application site) adverse events in the test arm versus the placebo vehicle. This extremely low rate of application site adverse events compares very favorably to FDA approved potential competing products, including King’s Flector Patch at roughly 11% (per the package insert) and Novartis / Endo’s Voltaren Gel at roughly 7% (per the package insert).

Additionally, there were no gastrointestinal, cardiac, liver, or other serious adverse events related to Ketotransdel during the program. Pharmacokinetic analysis shows no clinically relevant changes in blood and urine tests, and only minimal systemic absorption (mean Cmax 39 ng/mL). This low level of systemic absorption equate to only approximately 1 to 2 % of the oral ketoprofen dose.

Moving Forward in Development

In order to gain approval, the company will need to conduct a second confirmatory phase III clinical study in acute soft tissue pain. Management is currently assessing the design and timing of this second study to support the registration of Ketotransdel in the U.S. We believe it is management’s plan to conduct a mirror image study of the first phase III program which greatly minimizes risk in our view along with certain modifications to the inclusion criteria (conducing urinalyses prior to randomization) so that non-qualifiers are eliminated prior to the randomization.

The timing of the second phase III trial and the other supportive studies will be dependent on obtaining adequate financing to support the execution of these activities and for other working capital expenditures. The trial will probably cost several million dollars to conduct and should take 9 to 12 months to complete. Assuming a conservative timeline with relation to a partnership, we believe the company and its partner should be in position to begin this program late 2010 or early 2011.

Transdel is doing all the necessary pre-work with the contract research organization (CRO) so that the trial is ready to begin immediately after the funding becomes available. Transdel is currently assessing the necessary steps to gain marketing authorization outside the U.S. as well. At this time, all of our financial models include sales for Ketotransdel in the U.S. only.