MONTREAL, Sept. 2 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced today the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada. TDLP-110, the Company's lead pain product candidate, utilizes its transdermal delivery platform to deliver the active drug ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects.
The complete analyses of the Phase 3 data confirm that:
- Ketoprofen 10% cream (TDLP-110) treated patients had statistically significant greater reductions in pain intensity than placebo treated patients;
- TDLP-110 cream demonstrated excellent safety and tolerability;
- There were no treatment related gastrointestinal, cardiac, liver or other serious adverse events;
- There were no clinically relevant changes in blood and urine tests;
- Minimal blood concentrations of ketoprofen were detected in the pharmacokinetic (PK) sub-study, supporting the excellent safety profile of TDLP-110.
"The data of the TDLP-110 Phase 3 trial confirm that it is an effective product candidate for reducing pain of acute soft tissue injuries and is very well tolerated," said lead clinical investigator Evan F. Ekman, M.D. and President and Medical Director of Southern Orthopaedic Sports Medicine, Columbia, SC. "TDLP-110 has the potential to offer a new standard in topical pain management with an active ingredient and an elegant cream formulation that once approved differs from available topical NSAID treatments. In particular, I am impressed by the excellent cutaneous/application site tolerability."
The presented poster titled "EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN THE TREATMENT OF PAIN ASSOCIATED WITH ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001)" summarizes the key efficacy data from Intent-to-treat (ITT) analysis and safety data of all patients randomized. In agreement with statistical (ICH-E9) guidelines a total of 35 patients were excluded from the original ITT population of 361 patients since they did not meet study entry criteria and should not have been enrolled based on information that was not known at the time of enrollment. This modified ITT (mITT) population included 326 patients.
Using the primary endpoint, which was the change from baseline in pain intensity during daily activity over the previous 24 hours at the Day 3 visit, the study demonstrated statistical significance (p=0.038) in the mITT population and approached statistical significance (p=0.087) in the original ITT population. Pain during activity scored 3 times daily by patients over seven days also supports the primary endpoint by demonstrating a consistent separation between the TDLP-110 and placebo groups over time, and showed statistical significance between the two groups in the ITT analyses.
The proportion of patients who were satisfied with the treatment and achieved moderate or higher pain relief - as recorded on a seven-point Likert Scale - was greater with TDLP-110 (p=0.023). Time to onset of meaningful pain relief was assessed and was about 40 minutes faster in TDLP-110 treated patients. Time to end of meaningful analgesic effect was about 45 minutes longer in the TDLP-110 treated group.
TDLP-110 demonstrated excellent safety and tolerability with a low overall incidence (18.1% vs. placebo 20.3%) of adverse events (AEs) and no treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant AEs. The incidence of related cutaneous/application site adverse events was slightly lower with TDLP-110 (1.1% vs. placebo 2.2%, respectively). There were no clinically relevant shifts from baseline in laboratory parameters (hematology, coagulation, serum chemistry, and urinalysis). The estimated systemic absorption of TDLP-110 is about 1 - 2 % of a comparable oral ketoprofen dose. In a pharmacokinetic sub-study of this Phase 3 trial minimal blood concentrations (mean Cmax 39.0 ng/mL) of ketoprofen were measured at steady-state, which is consistent with previous Phase 1/2 study findings. This Phase 3 study (TDLP-110-001) demonstrated that TDLP-110 was more effective than placebo in reducing pain of acute soft tissue injuries and was very well tolerated.
"Today's presentation of our data at the world's premier congress devoted to research and treatment of pain is a significant event for our company," stated Joachim Schupp, M.D., Chief Medical Officer at Transdel Pharmaceuticals. "We believe that study TDLP-110-001 could serve as one of two required confirmatory trials of evidence of efficacy for TDLP-110 and we plan to initiate the second trial upon sufficient funding."
To view the poster presented at the conference, please visit the Company's website at www.transdelpharma.com.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product candidate, has completed a Phase 3 clinical trial and utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. For more information, please visit http://www.transdelpharma.com.
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotransdel®; the Company's ability to obtain regulatory approval to market Ketotransdel; and the Company's ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the FDA may not agree with the Company's interpretation of the results of the Phase 3 clinical trial for Ketotransdel or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial; the FDA may require the Company to complete additional clinical trials for Ketotransdel® before the Company can submit a 505(b)(2) NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel®; and the Company's current need to raise additional funding to complete its product development and clinical trial plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SOURCE Transdel Pharmaceuticals, Inc.