LA JOLLA, Calif., April 7, 2008 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News) announced today that based on the U.S. Food and Drug Administration’s (“FDA”) review of its Phase 3 submission the Company can initiate its Phase 3 clinical program for its novel topical cream based non-steroidal anti-inflammatory drug (“NSAID”), Ketotransdel(TM). Transdel Pharmaceuticals is a specialty pharmaceutical company pursuing the development and commercialization of non-invasive topically administered medications.
Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals, stated, “I am pleased to announce that the FDA has reviewed our February 7, 2008 FDA submission and has stated that it is safe to proceed with the Phase 3 program. The FDA also noted that there are no clinical hold issues and provided comments regarding the registration requirements of our lead drug. We will continue our discussions with the FDA regarding the final product approval requirements.” Dr. Singh continued, “Advancing into Phase 3 clinical studies for Ketotransdel marks a significant milestone for the Company. Our dedicated and committed team is focused on successfully advancing our topical drug to FDA approval.”
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 FDA, could become the first topical NSAID cream product in the United States for acute pain management. The drug could address a significant unmet medical need for patients with medical conditions and those patients seeking safer alternatives to the standard pain management approaches.
In the second quarter of 2008, the Company intends to initiate the randomized, double-blind, placebo controlled Phase 3 program to evaluate the efficacy and safety of Ketotransdel in acute pain care management. The Company also stated that in the near term it will be announcing organizational changes as the company transitions into late stage clinical phase.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company pursuing the development and commercialization of non-invasive topically delivered medications. The Company’s lead topical drug, Ketotransdel, utilizes the Company’s innovative patented Transdel(TM) cream formulation technology to facilitate the passage of ketoprofen, an NSAID, through the skin barrier to reach targeted underlying tissue where the drug can exert its prolonged localized anti-inflammatory and analgesic effect. The Company is also investigating other drug candidates and treatments for transdermal delivery using the patented Transdel platform technology for products in pain management and other therapeutic areas. 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 within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. 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. 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 future financial results, additional financing requirements, development of new products, government approval processes, 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 the company’s Annual Report on Form 10-KSB filed with the SEC on March 26, 2008. Such documents may be read free of charge on the SEC’s web site at http://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.
