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 anadequate method of birth control.

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

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

Exclusion Criteria:

• Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesivecapsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/orbursitis of the shoulders, bicipital tendonitis; or orthopedic surgical treatment isrequired.

• Subject has a positive Drop Arm Test indicative of a suspected tear; a positiveO'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test whichwould be indicative of glenohumeral instability; a positive Yergason's Test whichwould be indicative of bicipital tendonitis.

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

• Subject received passive physical therapy treatments for the pain in the targetshoulder within the past 24 hours.

• Subject has used oral pharmacologic treatment less than 5 half-lives before thebaseline assessments.

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

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

• Subject recently initiated sleep medications, muscle relaxants, anticonvulsants orantidepressants (within the past 30 days).

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

• Subject has a history or physical assessment finding of clinically significant GIulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlledlung, stomach, heart, or other vital organ disease as determined by the studyinvestigator/physician.

• Subject has fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis suchas rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritisis 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 anerve entrapment syndrome or other medical problem that in the investigator's opinionmay interfere with pain measurement of the target joint.

• Subject has active skin lesions or disease at the intended site of study medicationapplication, 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 theperiod of study participation.