An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

Inclusion Criteria:

- Subject must provide informed consent before any study specific evaluation is
performed.

- Subject is male or female aged 18 to 70 years, inclusive.

- Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional
impairment) ankle strain or sprain that occurred within 48 hours before the Screening
visit.

- Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive,
measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest
that is less than upon monopodal weight bearing.

Exclusion Criteria:

- Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral
strain or sprain, or concomitant fracture or wound at the site of the strain or
sprain.

- Subject has had an ankle strain or sprain to the same foot within 6 months before the
Screening visit.

- Subject has received topical analgesic medication within 24 hours before the
Screening visit.

- Subject has applied ice or compression to the injured area within 2 hours before the
Screening visit.