Healthcare Industry News: Transdermal
News Release - February 7, 2008
Transdel Pharmaceuticals Submits to the FDA the Phase 3 Clinical Study of Ketotransdel(TM) for the Treatment of Acute PainLA JOLLA, CA--(Healthcare Sales & Marketing Network)--Feb 7, 2008 -- Transdel Pharmaceuticals, Inc. (OTC BB:TDLP.OB ), a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically targeted medications, announced today that it submitted its Phase 3 clinical study to the Food and Drug Administration (FDA) for the Company's lead topical drug, Ketotransdel(TM). Ketotransdel is a novel, topical cream-based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. The Company plans to initiate Phase 3 clinical trials following the FDA's 30-day review period.
The proposed Phase 3 trial will be a randomized, double-blind, placebo controlled study of the efficacy and safety of Ketotransdel in acute pain care management. Transdel plans to begin the trial in the second quarter of 2008.
Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals, stated, "This filing is a notable milestone in the advancement of our proprietary Transdel(TM) technology utilizing Ketotransdel for the treatment of acute pain. The filing has addressed all of the items that were requested by the FDA at a previous meeting between the Company and FDA personnel. These items included the proposed Phase 3 clinical protocol, the completed non-clinical studies and detailed manufacturing information."
Dr. Singh continued, "We believe Ketotransdel's mechanism of action has the potential to offer patients with pain and inflammatory conditions an attractive alternative to the current therapeutic options, while avoiding side effects associated with approved oral NSAIDs and the Cox-2 inhibitors."
Ketotransdel was previously studied in a double blind, randomized, placebo-controlled Phase 1/2 clinical study. The study tested the efficacy and safety of Ketotransdel for the treatment of acute pain and soreness. The trial demonstrated that Ketotransdel provided effective local delivery of ketoprofen, the active compound in Ketotransdel, resulting in statistically significant relief of pain and soreness with minimal systemic exposure to the drug.
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 cardiovascular, gastrointestinal and other risks associated with orally administered NSAIDs, and the decline in the use of Cox-2 inhibitors because of safety concerns, the Company believes that there is a significant demand for topical pain management products such as Ketotransdel. Moreover, the Company hopes that Ketotransdel, upon FDA approval, would be 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.
Conference Call and Webcast
Dr. Juliet Singh, President and CEO, and John Lomoro, CFO, will host a conference call to update shareholders on the business developments that have taken place. The conference call will take place at 4:15 p.m. Eastern Time, on Thursday, February 7, 2008. Anyone interested in participating should call 800-762-8779 if calling within the United States, or 480-248-5081 if calling internationally, approximately 5-10 minutes prior to 4:15 p.m. Eastern Time. There will be a playback available until February 14, 2008. To listen to the playback, please call 800-406-7325 if calling within the United States, or 303-590-3030 if calling internationally. Please use pass code 3842547 for the replay.
This call is being webcast by ViaVid Broadcasting and can be accessed at Transdel's Web site at http://www.transdelpharma.com. The webcast may also be accessed at ViaVid's Web site at http://www.viavid.net. The webcast can be accessed through March 3, 2008, on either site.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTC BB:TDLP.OB ) is a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically delivered medications. The Company's lead topical drug, Ketotransdel(TM), utilizes the Company's innovative patented proprietary 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 exerts 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(TM) platform technology for products in pain management and other therapeutic areas.
Safe Harbor Statement
The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks 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, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.
Source: Transdel Pharmaceuticals
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