- Pooled analysis published in Pain and Therapy indicated that the number of rescue medication tablets used per day through Week 24 was significantly less for ZILRETTA versus placebo and triamcinolone acetonide crystalline suspension (TAcs)
- Reduced rescue medication use further supports the analgesic effect of ZILRETTA, and may be a potential benefit of ZILRETTA for patients with osteoarthritis (OA) knee pain
BURLINGTON, Mass., May 10, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. FLXN today announced that a pooled analysis of data from three Phase 2/3 randomized clinical trials on the use of rescue medications with ZILRETTA (triamcinolone acetonide extended-release injectable suspension) were published in Pain and Therapy. The analysis indicated that rescue medication use was significantly lower following a single injection of ZILRETTA, the first and only extended-release intra-articular therapy for OA knee pain, in comparison to placebo and TAcs.
In clinical trials that evaluate the efficacy of pain therapies, rescue medications, such as acetaminophen, may generally be used by patients to manage acute episodic pain when the primary treatment is not providing sufficient relief. Measuring rescue medication use can provide important information on the robustness of the overall analgesic effect, as effective pain medications should reduce the need for rescue medications and lower the cumulative exposure to potentially harmful side effects.
"The fact that ZILRETTA reduced patients' use of acetaminophen speaks to the magnitude of analgesia that ZILRETTA can provide, and its potential to also limit the need for rescue medications, including addictive options, like opioids," said Alan Kivitz, MD, Altoona Center for Clinical Research.
Key topline results from the Phase 2/3 studies:
- The overall number of rescue medication tablets used per day through Week 24 was significantly less for ZILRETTA compared to saline-placebo (LSM difference, −0.43) and TAcs (–0.24); and
- The safety profile of ZILRETTA in this pooled analysis was consistent with that of the pivotal Phase 3 trial.
"All too often, patients diagnosed with OA of the knee find themselves in an endless cycle with brief periods of relief, commonly followed by quick recurrence of pain," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "The publication of this analysis in a peer-reviewed journal further supports the substantial relief that ZILRETTA can offer patients coping with OA knee pain."
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 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. Learn more at www.zilretta.com.
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 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 market potential and potential benefits; 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 developing and obtaining regulatory approval for product candidates; the fact that results of past clinical trials may not be predictive of subsequent trials; 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 to commercialize ZILRETTA; 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; the risk that we may use our capital resources in ways that we do not currently expect; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed with the SEC on May 8, 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
Julie Downs
Senior Manager, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7137
jdowns@flexiontherapeutics.com
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