Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

This study was a double-blind, randomized, single dose design. The study was conducted in
male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients
with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a
single IA injection of:

- 32 mg FX006,

- normal saline (placebo), or

- 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity
(ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following
screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline],
Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Inclusion Criteria:

- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow verbal and written instructions

- Male or female >=40 years of age

- Has symptoms associated with OA of the index knee for at least 6 months prior to
Screening

- Currently meets American College of Rheumatology (ACR) Criteria (clinical and
radiological) for OA

- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray

- Index knee pain for > 15 days over the last month

- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

- Body mass index (BMI) ≤ 40 kg/m2

- Willingness to abstain from use of restricted medications

Exclusion Criteria:

- Any condition that could possibly confound the patient's assessment of index knee pain
in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back
pain and hip pain that is referred to the knee that could cause misclassification,
pain in any other area of the lower extremities or back that is equal or greater than
the index knee pain)

- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, arthritis associated with inflammatory bowel disease

- History of infection in the index knee

- Clinical signs and symptoms of active knee infection or crystal disease of the index
knee within 1 month of Screening

- Unstable joint within 12 months of screening

- IA corticosteroid (investigational or marketed) in any joint within 3 months of
Screening

- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
Screening

- Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1
month of Screening

- Any other IA investigational drug/biologic within 6 months of Screening

- Prior use of FX006

- Women of child-bearing potential not using effective contraception or who are pregnant
or nursing