LA JOLLA, Calif., June 15 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. a specialty pharmaceutical company focused on developing non-invasive, topically administered products, announced that they anticipate reporting top-line results from their current Phase 3 study of Ketotransdel(R) during the third quarter of 2009.
The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug ("NSAID"), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the United States and will enroll approximately 350 patients. 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.
If approved by the U.S. Food and Drug Administration ("FDA"), Ketotransdel could become the first topical NSAID cream product in the United States for acute pain management, which is a multi-billion dollar market. 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. If and when the FDA approves Ketotransdel for treatment of acute pain, we intend to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis. Furthermore, we are 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.
We believe that the clinical success of Ketotransdel will facilitate the use of the Transdel(TM) delivery technology in other products. We have identified co-development opportunities for potential products in pain management and other therapeutic areas utilizing the Transdel(TM) platform technology and we are exploring potential partnerships for these identified products. Some of these identified co-development areas include hormone based products, antiemetic and dermatological products. We are also looking to out-license our Transdel(TM) drug delivery technology for the development and commercialization of additional innovative drug products.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. 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. The Company is actively investigating other product candidates for transdermal delivery using the Transdel(TM) platform technology and is also actively pursuing partnerships with other groups or 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.
CONTACT: John Lomoro, CFO of Transdel Pharmaceuticals, Inc.,
Web site: http://www.transdelpharma.com/