Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder

Inclusion Criteria:

- Females of child bearing potential must have a negative pregnancy test and be using an
adequate method of birth control.

- Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis
and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24
hours and ≤ 7 days preceding the screening visit.

- Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a
Numeric Pain Rating Scale (NPRS).

Exclusion Criteria:

- Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive
capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or
bursitis of the shoulders, bicipital tendonitis; or orthopedic surgical treatment is
required.

- Subject has a positive Drop Arm Test indicative of a suspected tear; a positive
O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which
would be indicative of glenohumeral instability; a positive Yergason's Test which
would be indicative of bicipital tendonitis.

- Subject had a previous episode of shoulder pain in the same area within two weeks
prior to the current episode; history of chronic pain in the target shoulder; history
of rotator cuff injury or previous surgery in the same area.

- Subject received passive physical therapy treatments for the pain in the target
shoulder within the past 24 hours.

- Subject has used oral pharmacologic treatment less than 5 half-lives before the
baseline assessments.

- Subject has used any form of opioid within 24 hours of study entry or use of opioids
for 5 or more consecutive days within the 30 days preceding enrollment.

- Subject has received systemic corticosteroids in the 30 days preceding the screening
visit; or local injections such as intra-articular, bursal, peritendinous; topical
corticosteroids are acceptable unless applied to the target joint; and inhaled or
intranasal steroids acceptable (e.g., Flonase®).

- Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or
antidepressants (within the past 30 days).

- Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60
days.

- Subject has a history or physical assessment finding of clinically significant GI
ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled
lung, stomach, heart, or other vital organ disease as determined by the study
investigator/physician.

- Subject has fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis such
as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis
is acceptable as long as it does not affect the injured area.

- Subject has a painful syndrome (e.g. sciatica) or cervical spine disorder leading to a
nerve entrapment syndrome or other medical problem that in the investigator's opinion
may interfere with pain measurement of the target joint.

- Subject has active skin lesions or disease at the intended site of study medication
application, which may be covered by the patch. Skin lesions include open wounds,
rash, papules and vesicles; abrasions, lacerations or any break in skin.

- Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives
(e.g., adhesive tape).

- Subject is scheduled for elective surgery or other invasive procedures during the
period of study participation.