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 onset
of the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosis
is indicated by a positive Hawkins Test and Neer Test, both resulting in pain with
motion 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 a
Numeric 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 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.

- 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; requires
continued use of an immobilization device for treatment of the current episode of
tendonitis or bursitis or use of iontophoresis.

- Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less
than 3 half-lives before the baseline assessments; ibuprofen is permitted prior to
baseline 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 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.

- Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or
antidepressants.

- 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 a history or physical assessment finding that is not compatible with safe
participation in the study.

- Subject has a pain or 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 application of the
study 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 receiving
study medication.

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

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