re P3 results next Week..Under Radar
Lead Drug In Phase 3 Trial Has Potential To Be First FDA-Approved Prescription Topical NSAID Cream Product
LA JOLLA, Calif.--Freud’s pleasure principle dictates that humans continuously drive to seek pleasure and avoid pain. And our daily lives provide proof: we pop Tylenol for headaches, take non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen for pain, and use stronger but riskier analgesics—including narcotic drugs such as morphine, synthetic drugs with narcotic properties such as tramadol, and various others—to relieve very severe pain.
The problems associated with these drugs are not insignificant. Apart from the risk of painkiller abuse and addiction, over one hundred thousand patients are hospitalized each year due to orally administered NSAID-related gastro-intestinal (GI) complications. That is because when one takes a pill, it passes from the GI tract into the bloodstream and organs, exposing one to cardiovascular, renal, and hepatic systemic effects. It is to a patient’s great advantage, therefore, to use topical drugs that can be applied locally for pain thereby potentially allowing just a small fraction of the dosage to enter the body systemically and resulting in fewer medical complications.
Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically delivered medications. The Company’s lead topical drug, Ketotransdel®, utilizes the company’s innovative proprietary Transdel™ cream formulation to facilitate the passage of ketoprofen, considered one of the best NSAIDs for topical application, through the skin barrier to reach targeted underlying tissue where the drug exerts its localized anti-inflammatory and analgesic effect.
The company’s Phase 3 clinical program for Ketotransdel® is currently in progress and they are working with Cato Research Ltd. as their CRO and strategic partner to conduct the trial. If approved by the FDA, Ketotransdel® has the potential to be the first topical NSAID cream product available in the U.S. for acute pain management. The commercial opportunity for such a topical, potentially safer and more effective NSAID treatment is enormous as more than thirty million people worldwide take NSAIDs daily. In the U.S., annual sales of NSAIDs and Cox-2 inhibitors exceed $6 billion (pain medications being the third most commonly prescribed class of drugs in the U.S.).
The Transdel™ platform technology has the potential to create a deep and rich product pipeline as it offers an effective cream based delivery system capable of delivering a variety of drugs, sizes and dosages. These include a number of generic and proprietary drugs, cosmetic/cosmeceutical and nutritional co-development opportunities.
Proprietary Transdel™ Technology
* Proprietary transdermal cream drug delivery platform enables the avoidance of first pass metabolism by the liver and minimizes systemic exposure
* Facilitates effective dissolution and delivery of drug across the skin barrier to reach targeted underlying tissues
* Ideal drug delivery system
o Biocompatible with human skin
o High skin penetrating qualities
o Delivers sufficient quantities and sizes of drugs
o Strong safety profile associated with the delivery system
Ketotransdel® Lead Topical Drug
* Phase 3 clinical program in progress for treatment of acute pain
* Comprised of a transdermal formulation of ketoprofen, an NSAID
o Ketoprofen selected as active ingredient for its proven clinical, safety, and efficacy track record
* Effectively penetrates skin barrier to reach the targeted underlying tissue where it exerts its localized anti-inflammatory and analgesic effect
* The topical delivery of the drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, renal, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs
* If approved, Ketotransdel® could be the first topical NSAID cream in the U.S. for pain
Market Opportunity
* Withdrawal of Cox-2 inhibitors Bextra and Vioxx leaves multi-billion dollar market void largely replaced by oral NSAIDs
* NSAIDs and Cox-2 inhibitors market > $6B
o More than thirty million people worldwide using prescription and over the counter NSAIDs daily, making this one of the most prescribed class of drugs in the pain management market
* Recent recognition of cardiovascular, gastrointestinal and other risks associated with orally administered NSAIDs and decline in use of Cox-2 inhibitors related to safety concerns provides market opportunity for topical pain management products
Sales and Marketing
* Company is in discussions with commercial partners for future sales and marketing strategies related to Ketotransdel® and other co-development opportunities.
* In addition, the Company is discussing with potential pharma partners licensing opportunities related to the TransdelTM delivery system.
Intellectual Property
* Over five hundred different drugs are specifically listed in more than sixty therapeutic areas
* Transdel Pharmaceuticals owns U.S. patented proprietary Transdel™ technology
* Broad technology platform that is patent protected
o Patent specifically covers composition of matter, methods of manufacture and methods of use
o Patent covers novel formulation with any medication capable of being administered transdermally
Clinical Results of Ketotransdel® Phase 1/2 Trial
* Double blind, randomized placebo-controlled
* Assessed efficacy, safety and systemic levels for treatment of acute pain and soreness
* Demonstrated effective local delivery of ketoprofen resulting in statistically significant relief of pain and soreness
* Low serum concentrations of drug enhanced safety profile
* No significant adverse reactions reported
Market Research Study
* Market research study conducted by an independent consulting firm concluded that Ketotransdel®:
o Will be well accepted by physicians and patients
o Could be used for a variety of acute and chronic pain conditions
* Potential drug utilization frequency of Ketotransdel® by physicians and patients could be high
