Navigation Links
Transdel Enrolls First Patient for Ketotransdel(TM) Phase 3 Clinical Trial
Date:9/22/2008

LA JOLLA, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing non-invasive, topically administered medications, today announced it has enrolled its first patient in the Phase 3 registration trial for Ketotransdel(TM). Ketotransdel(TM), a novel analgesic and anti-inflammatory topical cream, contains 10% ketoprofen (a non-steroidal anti-inflammatory drug, "NSAID"), and is intended for use in the treatment of acute pain from musculoskeletal conditions.

The Ketotransdel(TM) Phase 3 registration study entitled: "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel(TM) in the Treatment of Pain Associated with Mild to Moderate Acute Soft Tissue Injury," will be conducted at approximately 25 to 35 sites in the United States and potentially in Canada. The Company expects to enroll approximately 350 patients of which 50% will be provided Ketotransdel(TM) and 50% a placebo vehicle. The Phase 3 study currently has three sites that are actively screening for patients. It is expected that the majority of the sites will be activated during October and November. The Company expects to report top-line results in the second half of 2009.

In the Phase 3 study, the primary efficacy endpoint will be the difference in the change of baseline pain between Ketotransdel(TM) and placebo at Day 3. This endpoint is measured by using the Visual Analogue Scale (VAS), a validated and widely used scale for recording pain which 0 indicates "no pain" and 100 indicates "the worst imaginable pain." The secondary endpoints will include safety assessments and other efficacy parameters measured by VAS at Day 3 and Day 7. In addition to evaluating for efficacy and safety over the one week period, the study will also assess safety at one week post-treatment.

"We are excited about reaching this important milestone, the dosing of our first patient. Along with our strategic partner and contract research organization, Cato Research Ltd., we continue to be extremely focused on enrolling appropriate patients and initiating new sites to meet our corporate goals," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "Ketotransdel(TM) could address a significant unmet medical need for patients and physicians seeking a potentially safer effective pain alternative to existing pain management approaches, such as oral NSAIDs. We are committed to aggressively advancing this program to fulfill this unmet medical need."

Ketotransdel(TM) which consists of an elegant cream formulation is designed to be applied directly to the site of the pain. It is absorbed within minutes and is not associated with the limitations of patches. Musculoskeletal pain conditions are defined as pain that affects the muscles, ligaments and tendons. If approved, Ketotransdel(TM) could be the first topical cream in the United States for treatment of acute pain related to musculoskeletal conditions.

Industry estimates indicate that the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year and that 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 due to safety concerns, the Company believes that there is a significant demand for topical pain management products such as Ketotransdel(TM).

If and when the FDA approves Ketotransdel(TM) for treatment of acute pain, the Company intends to pursue FDA approval of Ketotransdel(TM) for other indications, such as osteoarthritis. The Company believes that the clinical success of Ketotransdel(TM) will facilitate the use of the Transdel(TM) delivery technology, which is utilized in Ketotransdel(TM), in other products. Accordingly, the Company is investigating other drug candidates and treatments for transdermal delivery using the Transdel(TM) platform technology for products in pain management and other therapeutic areas. Furthermore, the Company is exploring potential partnerships with U.S. and foreign based companies that have sales and marketing infrastructures to support Ketotransdel(TM) in the event that the product is approved and commercialized. The Company is also looking to out-license its Transdel(TM) drug delivery technology for the development and commercialization of additional innovative drug products.

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP) is a specialty pharmaceutical company developing non-invasive, topically-delivered medications. The Company's innovative patented proprietary Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of drugs through the tough skin barrier to reach the target underlying tissues. In the case of Ketotransdel(TM), the Transdel(TM) cream allows the active ingredient ketoprofen to reach the target soft tissue and exert its well-known anti-inflammatory and analgesic effects. 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. 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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Transdel Pharmaceuticals Advances Lead Topical Pain Drug into Phase 3 Program
2. Transdel Initiates Ketotransdel(TM) Phase 3 Clinical Program for Pain
3. Spectranetics Enrolls First Patient in PATENT Trial for the Treatment of Instent Restenosis
4. VIA Pharmaceuticals Enrolls First Patient in Phase 2 Clinical Trial to Measure Impact of VIA-2291 to Reduce Vascular Inflammation
5. Nventa Enrolls and Initiates Dosing of Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial
6. Micromet Enrolls First Patient in a Phase 1 Clinical Trial with MT110, the First BiTE Antibody for Treatment of Solid Tumors
7. Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
10. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
11. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... IRVINE, Calif., Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: ... quarter ended December 31, 2015. The Company also filed its ... fiscal year 2016 with the Securities and Exchange Commission today. ... December 31, 2015 --> --> ... 2015 increased $2.6 million, or 95%, to $5.4 million from ...
(Date:2/11/2016)... has committed to provide drug disposal kiosks in ... as part of a program to combat drug ... organization As You Sow. Conrad MacKerron , Senior ... to unneeded drugs because they lack easily accessible collection and ... Conrad MacKerron , Senior Vice President at As You ...
(Date:2/11/2016)... -- Potrero Medical, Inc., the developer of the Accuryn™ critical ... George M. Rapier, III , MD, to its Board ... WellMed is one of the nation,s largest physician owned practice ... Texas and Florida ... internal medicine practice, he has been instrumental to the company,s ...
Breaking Medicine Technology:
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... through a world of exterior design possibilities. CertainTeed, North America’s leading brand of ... by expanding the product offerings showcased in the mobile version of the ColorView® ...
(Date:2/12/2016)... ... ... Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to its annual Winter Teen Dance. ... and without special needs to gather in a safe and supportive environment. Volunteers will be ... place on Saturday, Feb. 13 from 7 to 9:30 p.m. at Elks Lodge, 322 Elks ...
(Date:2/12/2016)... ... 2016 , ... Planet Future is a Final Cut Pro X ... for showcasing pictures, videos as well as text in an exciting cartoon environment. Planet ... and a beautiful frame overlay. Pixel Film Studios makes editing easy; simply insert media ...
(Date:2/11/2016)... ... February 11, 2016 , ... “ HEALING MIND : ... Well Managed Mind” (published by Balboa Press) teaches readers how to become their own ... profound love, author Janice McDermott, M.Ed., LCSW, offers an understanding of how to heal ...
(Date:2/11/2016)... Jersey (PRWEB) , ... February 11, 2016 , ... Registered ... a free CEU seminar titled, “Stroke Management: Time to Act, Time to Heal” on ... Community in Whippany, N.J. The presenter is Vishal Chedda, president of ANSA Consultants, ...
Breaking Medicine News(10 mins):