LA JOLLA, Calif., July 8 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP) a specialty pharmaceutical company focused on developing non-invasive, topically administered products, today announced they have successfully completed the enrollment of patients in their pivotal Phase 3 clinical study for Ketotransdel(R), a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain.
Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel. Moreover, the Company expects that Ketotransdel, if approved by the U.S. Food and Drug Administration ("FDA"), could become the first topical NSAID cream product in the U.S. for acute pain management. Also, the Company intends to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis. The drug could address what the Company believes is a significant unmet medical need for patients and physicians seeking a potentially safer alternative to existing pain management approaches, such as oral NSAIDs.
"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."
The Phase 3 clinical study is a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel. Over 350 patients were enrolled at approximately 30 centers throughout the United States. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3.
Transdel Pharmaceuticals is seeking a partner for Ketotransdel and is either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
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(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel(R), the Company's lead pain product, utilizes the Transdel(TM) technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug ("NSAID"), 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(TM) 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. The Company recently announced that they entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
Statements made in this release that are not historical in nature constitute forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Please note that forward-looking statements are based on projections, that these projections involve judgment, and that individual judgments may vary. Moreover, these statements are subject to risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the uncertainty of the Company's future financial results and its ability to raise additional funds to support its operations, its ability to complete the required clinical trials and obtain FDA approval for Ketotransdel, the efficacy and the commercial success of any cosmetic/cosmeceutical products it develops, the impact of competitive products or pricing, and technological changes. 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. All forward-looking statements included in this release are made as of the date of this press release, and the Company assumes no obligation to update any such forward-looking statements.
|SOURCE Transdel Pharmaceuticals, Inc.|
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