Flexion Therapeutics Enrolls First Patients in Phase 2 Trial of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in OA of the Shoulder and Adhesive Capsulitis
“Shoulder OA and AC are both associated with pain and limited range of motion which can significantly compromise a person’s function and quality of life,” said
The Phase 2 trial, known as the RANGE study, will separate cohorts of patients by their diagnosis of shoulder OA or AC into two parallel groups. Patients in each cohort will be randomized (1:1) to either a single intra-articular injection of ZILRETTA or normal saline. The primary endpoint for both cohorts of the trial is the magnitude of pain relief versus placebo as measured by the overall change in daily shoulder pain with movement score from baseline to 8 weeks post injection. Patients in each cohort will be stratified by baseline pain scores. Shoulder AC patients will be further stratified by pain duration since onset and will also utilize a home exercise program during the study.
Each participant will be evaluated for 24 weeks following injection. The trial is expected to complete in the first half of 2021.
Indication and Select Important Safety Information for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with
Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing Information.
About Shoulder Osteoarthritis & Adhesive Capsulitis
Osteoarthritis (OA), also known as degenerative joint disease, affects more than 30 million adults living in
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; expected timing and scope of clinical trials; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of ZILRETTA, are forward looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation; risks inherent in clinical development and the regulatory approval process, including the risk of delays in clinical trials and that future clinical results may not be consistent with prior results; risks related to the market and market conditions; and other risks and uncertainties described in our filings with the
Source: Flexion Therapeutics, Inc.