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Flexion Therapeutics Announces Publication of Independent Data Review of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in the Journal Drugs
Globe Newswire 2-Apr-2019 7:31 AM
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
BURLINGTON, Mass., April 02, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (NASDAQ:FLXN) today announced an independent evaluation of clinical data for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), conducted by Adis Drug Review, was published in the journal Drugs(Vol 79 (4) pp 455–462). The evidence-based evaluation concluded that ZILRETTA provided effective pain relief, while being generally well-tolerated as demonstrated in clinical studies, and it expands the treatment options for osteoarthritis (OA) knee pain.
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 Michael Clayman, M.D., Flexion's President and Chief Executive Officer.
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 Ontario and 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.
About ZILRETTA On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through Week 16.
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 $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.
About Flexion Therapeutics Flexion Therapeutics (NASDAQ:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and a Top Place to Work in Massachusetts by The Boston Globe.
Forward-Looking Statements 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 the United States; the risk that we may not be able to successfully maintain an effective sales force or product supply to commercialize ZILRETTA; potential delays in initiating or completing clinical trials; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized, including as a result of limitations in ZILRETTA's label and package insert information; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on February 28, 2019 and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
Contacts:
Scott Young Vice President, Corporate Communications & Investor Relations Flexion Therapeutics, Inc. T: 781-305-7194 syoung@flexiontherapeutics.com
