Flexion Therapeutics Announces Publication of Pooled Analysis of Phase 2/3 Data on Use of Rescue Medication with ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
- 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
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
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
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 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 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
Vice President, Corporate Communications & Investor Relations
Senior Manager, Corporate Communications & Investor Relations
Source: Flexion Therapeutics, Inc.