MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder

Main Inclusion Criteria:

• Subject is 14 years of age or older (with assent according to state law).

• Females of child bearing potential must have a negative pregnancy test.

• Subject has a diagnosis of acute tendonitis or bursitis of one shoulder with the onsetof the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosisis indicated by a positive Hawkins Test and Neer Test, both resulting in pain withmotion and the existence of shoulder impingement related to tendonitis or bursitis.

• Subject has a Current Pain Intensity rated prior to study entry ≥ 5 but ≤ 8 on aNumeric Pain Rating Scale (NPRS) (11 point; range 0 to 10; anchors to be "none" and "severe").

Main Exclusion Criteria:

• Subject has a suspected tear in the rotator cuff, calcific tendonitis.

• Standard of Care (SOC) diagnosis with an AP and lateral x-ray, adhesive capsulitis,shoulder fractures, bilateral tendonitis or bursitis of the shoulders; or orthopedicsurgical treatment is required.

• 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.

• Subject had a previous episode of shoulder pain in the same area within two months.

• Subject received passive physical therapy treatments (e.g., deep heat or ultrasound)for the tendonitis/bursitis for the target shoulder within the past 24 hours; requirescontinued use of an immobilization device for treatment of the current episode oftendonitis or bursitis or use of iontophoresis.

• Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) lessthan 3 half-lives before the baseline assessments; ibuprofen is permitted prior tobaseline as long as it is not within 6 hours of the baseline assessment.

• 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.

• Subject recently initiated sleep medications, muscle relaxants, anticonvulsants orantidepressants.

• 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.

• GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorlycontrolled lung, stomach, heart, or other vital organ disease as determined by thestudy investigator/physician.

• Subject has a history or physical assessment finding that is not compatible with safeparticipation in the study.

• Subject has a pain or medical problem that in the investigator's opinion may interferewith pain measurement of the target joint.

• Subject has active skin lesions or disease at the intended site of application of thestudy medication.

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

• Subject has a history of prior failed treatment with topical NSAIDs.

• Subject has a history of drug or alcohol abuse.

• Subject received an investigational drug within a period of 30 days prior to receivingstudy medication.

• Subject is scheduled for elective surgery or other invasive procedures during theperiod of study participation.

• Subject is on workman's compensation or has pending legal hearings.