1. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury W Carr, P Beks, C Jones, S Rovati, M Magelli, S Sun Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida

2. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury Soft tissue injuries, such as sprains, strains and contusions, are a common painful condition Current treatment includes oral nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects Topically applied drugs have the potential to act locally in the soft tissues without systemic effects Background Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida.

3. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury The 1.3% diclofenac epolamine topical patch is the first and only prescription anti- inflammatory pain relief patch in the U.S. The diclofenac epolamine patch(Flector ® ) has been available since January 2008 in the U.S. for the topical treatment of acute pain due to minor strains, sprains and contusions Background Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida.

4. To evaluate the efficacy and tolerability of the diclofenac epolamine patch in the treatment of minor soft tissue injury Objective Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

5. The efficacy and tolerability of the diclofenac epolamine patch was evaluated in a randomized, double-blind, placebo-controlled, parallel-group trial of 418 patients, aged 18-65 years who rated the minor soft tissue injuries they sustained within seven days of study entry as having a pain intensity of greater than or equal to 5 on a 0 to 10 scale Patients self-administered the patch every 12 hours to the injury site Methods Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

6. Primary Study Outcome: post-treatment pain, expressed as a proportion of the baseline pain score, which was recorded on a visual analog scale of 0 to 10 in a diary, twice-daily for 14 days, or until pain resolution Secondary Study Outcomes: included end-of- treatment Investigator Global Assessment of Response to Therapy (a five-point scale, "none" to "excellent"), and time to pain resolution (four scores less than or equal to two) Methods Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

7. Patient Characteristics Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Characteristic(N = 418) Men49.3% White99.5% Age (mean)38.9 yo Most common injuries treated Contusions42.6% Strains31.1% Sprains24.4% Most common injury sites Ankle, shoulder, knee and foot67.3% Efficacy of diclofenac epolamine patch 91.9%

8. Patients treated with the diclofenac epolamine patch experienced improved mean pain scores (40.4 percent of baseline score) versus patients using placebo patch (47.4 percent, p<0.05) Overall pain reduction was 14.8 percent Diclofenac epolamine patch patients also reached pain resolution three days sooner than those in the placebo patch group (median, 10.0 versus 13.5 days, p=0.01) Results Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

9. Additionally, at the conclusion of the study, the Investigator Global Assessment of Response to Therapy significantly favored the diclofenac epolamine patch: – patient response to treatment was rated "good" to "excellent" for 57.8 percent of diclofenac epolamine patch patients, versus 48.4 percent of placebo patch patients – and a "no"/"poor" response was given for only 24 percent of diclofenac epolamine patch patients versus 34.4 percent of placebo patch patients (p<0.01) Results Carr W et al. Presented at the 2008 American Pain Society Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

10. Adverse events were similar between the diclofenac epolamine patch and placebo patch The most common were application-site conditions, generally of mild severity – diclofenac epolamine patch: 7.9 percent – placebo patch: 5.8 percent Results Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

11. Results Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Diclofenac epolamine patchPlacebo patchp value Improved mean pain score (% of baseline score) 40.4%47.4%p<0.05 Pain resolution (median)10.0 days13.5 daysp=0.01 Investigator Global Assessment of Response to Therapy results Rated “good” or “excellent”57.8%48.4% Rated “no” or “poor”24%34.4%p<0.01 Adverse events Application-site conditions7.9%5.8%

12. The diclofenac epolamine patch yielded significant pain reduction for injuries due to strain, sprain, and contusion with a low incidence of very mild adverse events This novel pharmacotherapeutic delivery system has several important clinical advantages over currently available oral drug treatments, including the ease of use and lack of systemic activity and systemic side effects Conclusions Carr W et al. Abstract #8332. Presented May 9, 2008, at the American Pain Society 27th Annual Meeting in Tampa, Florida. Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury