Efficacy and Tolerability of the Diclofenac Epolamine Patch in the Treatment of Minor Soft Tissue Injury

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
Background

• 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

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
Background

• 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

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
4
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Objective

• To evaluate the efficacy and tolerability of the
  diclofenac epolamine patch in the treatment of
  minor soft tissue injury

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
5
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Methods

• 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

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
6
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Methods

• 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)

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
7
Patient Characteristics
Characteristic (N 418)
Men 49.3
White 99.5
Age (mean) 38.9 yo
Most common injuries treated Most common injuries treated
Contusions 42.6
Strains 31.1
Sprains 24.4
Most common injury sites Most common injury sites
Ankle, shoulder, knee and foot 67.3
Efficacy of diclofenac epolamine patch 91.9
Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
8
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Results

• 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, plt0.05)
• 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, p0.01)

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
9
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Results

• 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
  (plt0.01)

Carr W et al. Presented at the 2008 American Pain
Society Annual Meeting in Tampa, Florida.
10
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Results

• 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

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
11
Results
Diclofenac epolamine patch Placebo patch p value
Improved mean pain score( of baseline score) 40.4 47.4 plt0.05
Pain resolution (median) 10.0 days 13.5 days p0.01
Investigator Global Assessment of Response to Therapy results Investigator Global Assessment of Response to Therapy results Investigator Global Assessment of Response to Therapy results Investigator Global Assessment of Response to Therapy results
Rated good or excellent 57.8 48.4
Rated no or poor 24 34.4 plt0.01
Adverse events Adverse events Adverse events Adverse events
Application-site conditions 7.9 5.8
Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.
12
Efficacy and Tolerability of the Diclofenac
Epolamine Patch in the Treatment of Minor Soft
Tissue Injury
Conclusions

• 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

Carr W et al. Abstract 8332. Presented May 9,
2008, at the American Pain Society 27th Annual
Meeting in Tampa, Florida.