Flexion Therapeutics Announces Publication of Independent Data Review of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in the Journal Drugs
- Evaluation concluded that ZILRETTA provided effective pain relief, was generally well-tolerated, and expands the treatment options available for the management of osteoarthritis knee pain
- Comprehensive review included data from six clinical studies involving more than 1,300 patients
- Review provides an independent, evidence-based, and peer-reviewed evaluation of data on new or established treatments to define clinical potential
Adis Drug Review provides an independent analysis of data on new or established treatments, across all therapeutic areas, to determine clinical potential. Their assessment of ZILRETTA included data from six clinical trials conducted over the past seven years, which evaluated 1,347 patients, 613 of whom were treated with ZILRETTA.
“We believe this analysis provides a particularly important resource, as it presents clinicians and payers with a comprehensive view of ZILRETTA’s clinical trial data and the benefits it confers to patients with OA knee pain,” said
The Adis Drug Evaluation found:
- Treatment with a single injection of ZILRETTA provided significant pain relief in patients with OA knee pain relative to placebo with respect to average daily pain (ADP) scoring in clinical trials and provided a similar level of pain relief to that of a single injection of triamcinolone acetonide crystalline suspension (TAcs).
- In the Phase 3 trial, patients who received ZILRETTA reported improvements in pain, stiffness, and physical function compared with TAcs and placebo in pre-specified exploratory endpoints, which utilized the OA-specific
Western Ontarioand McMaster Universities Arthritis Index. Furthermore, they also reported improvements compared with TAcs and placebo on the Knee Injury and OA Outcome Score Quality of Life assessment.
- ZILRETTA had a similar tolerability profile to those seen with TAcs and placebo. ZILRETTA was generally well-tolerated with most adverse events (AEs) being of mild to moderate severity, and no radiographic evidence of rapidly progressing OA was observed over the 24-week study period in the Phase 3 trial.
- Patients with type 2 diabetes receiving ZILRETTA in the Phase 2 trial experienced a significantly smaller (p = 0.045) change in blood glucose elevation compared with those receiving TAcs and a negligible impact on their glycemic control.
- Results from the single-arm Phase 3b trial showed that the tolerability of repeat administration of ZILRETTA was consistent with that seen in the single administration Phase 3 trial. An analysis of radiographs (X-rays) taken at baseline and Week 52 showed no evidence of deleterious effects on cartilage or other aspects of joint structure with the repeat administration. Data suggest that a repeat administration of ZILRETTA may be similarly efficacious to an initial injection without further increasing the risk for AEs.
- The most frequent AE in patients who received two injections of ZILRETTA was arthralgia in any joint (joint pain without swelling), including two treatment-related arthralgia cases after the first injection and no treatment-related cases following the second injection.
- Additional studies with ZILRETTA, including longer-term evaluations, use in other joints, and head-to-head studies with TAcs, may be valuable in establishing relative efficacy and tolerability.
A randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of ZILRETTA in patients with hip OA is currently enrolling. The study is expected to complete in 2020.
Indication and Select Important Safety Information for ZILRETTA
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 the Adis Drug Review Program
The Adis Drug Review program, which includes Adis Drug Evaluations, Q&As and Biosimilar Briefs, provides clinically relevant information on the properties of new and established drugs, across all therapeutic areas. Adis Drug Reviews are single-agent, narrative reviews, written by the scientific editorial staff of Springer Nature and independently peer reviewed by international experts. In particular, Adis Drug Evaluations provide an independent analysis of the pharmacological properties, clinical efficacy and tolerability of an agent as well as evaluating new data to put forth the group’s recommendation on the agent’s clinical potential and appropriate place in therapy.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than
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; ZILRETTA's potential benefits; Flexion’s plans and expected timing for clinical and regulatory milestones and activities; and expected increases in the rate of individuals with OA of the knee, 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 associated with commercializing new pharmaceutical products in
Vice President, Corporate Communications & Investor Relations
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Source: Flexion Therapeutics, Inc.