Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel Primary Efficacy Endpoint Met Excellent Safety and Tolerability Profile Demonstrated Minimal Systemic

Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for

Lead Topical Pain Drug Ketotransdel

LA JOLLA, CA October 6, 2009 Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty

pharmaceutical company focused on developing topically administered products using its proprietary

transdermal delivery platform, today announced positive top-line clinical results for its lead pain

drug Ketotransdel in a Phase 3 trial which evaluated the efficacy and safety of the

drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel is

comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory

Drug), and the Company s innovative proprietary Transdel drug delivery system.

Top-Line Results and Trial Design

The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of

364 patients with acute soft tissue injuries in 26 centers in the United States.

The primary efficacy endpoint was the difference between Ketotransdel and placebo in

the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS)

during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated

instrument for pain measurement. The study achieved statistical significance in its primary

endpoint in the per protocol analysis. The statistical analysis of those patients that complied

with the study requirements (the per protocol (PP) population) included a total of 252 patients and

showed a positive and statistically significant outcome in the primary efficacy endpoint between

Ketotransdel and placebo, reaching a p-value of less than 0.05.

Secondary endpoints included safety assessments and other efficacy parameters.

Ketotransdel demonstrated an excellent safety and tolerability profile similar to the

placebo cream. In particular, there were no Ketotransdel treatment related

gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are

commonly observed with oral NSAIDs.

Ketotransdel was well absorbed through the skin with minimal blood concentrations of ketoprofen

detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the

Company s previous clinical study findings.

Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes

all study patients even if they failed to comply with the protocol and study requirements) favored

Ketotransdel compared to placebo but not to a degree that reached statistical

significance. We believe that this finding was not due to a lack of effect of

Ketotransdel , but rather due to patient compliance issues, non-adherence to protocol

procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or

concomitant use of unallowed drugs).

Based on these positive top-line clinical results and the excellent safety profile demonstrated,

we believe Ketotransdel is well-positioned to address a critical need in the pain

management marketplace. We are committed to continue working closely with the FDA to bring this

much needed drug to the marketplace as soon as possible, stated Dr. Juliet Singh, President and

Chief Executive Officer of Transdel Pharmaceuticals. In addition, this clinical study further

validates the great potential of our proprietary transdermal drug delivery platform, and we look

forward to maximizing the medical and commercial potential of this technology to bring important

therapies to patients.

There is a significant need among healthcare providers and patients for safe and effective

therapies for pain management, said lead clinical investigator Evan F. Ekman, M.D. and President

of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery

Center. The results from this Phase 3 clinical trial are very encouraging. They confirm to me

that Ketotransdel has a valuable role as a potentially safer and effective analgesic

and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which

are associated with gastrointestinal, cardiovascular and other medical problems.

Further detailed analyses are currently ongoing, and the Company intends to present the clinical

trial results at upcoming medical conferences and in peer-reviewed journals.

The Company expects that Ketotransdel, if and when approved by the United States Food and Drug

Administration (FDA), could become the first topical NSAID cream product available by prescription

in the United States for acute pain management. Transdel is seeking a commercial partner for

Ketotransdel , and is actively pursuing discussions with U.S. and foreign based

potential partners with sales and marketing infrastructures.

Ketotransdel is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal

Anti-inflammatory Drug), and the Company s innovative proprietary Transdel drug delivery system.

Ketoprofen was selected as the active ingredient for Ketotransdel for its proven clinical safety

and efficacy track record. In a previous randomized double-blind, placebo controlled Phase 1/2

trial, Ketotransdel provided effective local delivery of ketoprofen resulting in statistically

significant relief of pain and soreness with minimal systemic exposure to the drug. No adverse

reactions to Ketotransdel were reported. The Company also intends to pursue Ketotransdel for

other indications, such as osteoarthritis. The drug could address what the Company believes is a

significant unmet medical need for patients and physicians seeking a potentially safer alternative

to acetaminophen and oral NSAIDS such as ibuprofen and COX-2 inhibitors that have well-known

gastrointestinal, cardiac, renal and/or hepatic safety issues.

Acute Musculoskeletal Pain and Pain Market

Acute soft tissue injuries cause musculoskeletal pain that affects the muscles, ligaments, tendons

and/or bones. Treatment often includes the administration of oral non-steroidal anti-inflammatory

The pain market is the third most prescribed class of drugs in the United States. Oral formulations

of non-steroidal anti-inflammatory drugs (NSAID) currently are marketed worldwide for the treatment

of inflammation and pain, including pain due to musculoskeletal injuries, signs and symptoms of

osteoarthritis and rheumatoid arthritis, menstrual cramps, headache and other minor aches and

pains. Based on industry estimates, currently more than 30 million people world-wide use NSAIDs

daily. According to market research firm BCC Research the global market for pain relievers was

worth $19.1 billion in 2008, and is expected to grow to $32.8 billion by 2013. While traditional

oral NSAIDs are effective, they can cause serious gastrointestinal and cardiovascular adverse

events. Further, the withdrawal of some COX 2 inhibitors, a class of NSAIDs, has removed a major

therapeutic option for patients with multiple moderate and severe forms of pain, resulting in a

significant market opportunity. These developments have created an important need for a locally

administered pain product with a strong safety profile. Based on market research reports, the

United States transdermal drug delivery market is projected to increase from $3 billion in 2005 to

$4.5 billion in 2012.

Conference Call/Web Cast Information

Transdel will host a conference call/webcast to discuss matters mentioned in this release. The call

is scheduled for today, October 6, 2009, at 9:00 am, Eastern Time. To participate in this call,

dial 888 695-0608, or outside of the United States, dial 719-457-2615 and the confirmation code

4282348, shortly before 9:00 a.m., Eastern Time. A replay of the call will be available for a

limited period following the call, beginning at 12:00 p.m. Eastern Time today. The replay number is

719-457-0820, confirmation code 4282348. The audio webcast can be accessed at

www.transdelpharma.com.

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company developing

non-invasive, topically delivered products. The Company s innovative-patented Transdel cream

formulation technology is designed to facilitate the effective penetration of a variety of products

through the tough skin barrier. Ketotransdel , the Company s lead pain product, utilizes the

Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug