- An analysis of prospective radiographic assessments of 305 patients showedno adverse joint effects following treatment with ZILRETTA®
- Analysis of patient mobility indicated patients treated with ZILRETTA walked more steps per day in concert with pain reduction
- Survey of 1,000 patients with osteoarthritis of the knee (OAK) confirmed the substantial burden of disease with 95% of respondents reporting OAK negatively impacted their quality of life
BURLINGTON, Mass., May 01, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the publication of data from two new analyses of patients treated with ZILRETTA (triamcinolone acetonide injectable suspension), including an analysis of 305 patients in the Phase 3 and Phase 3b trials that showed treatment with ZILRETTA resulted in no deleterious impact on joint structure. A separate analysis indicated that patients treated with ZILRETTA demonstrated greater mobility and walked more steps per day following treatment. The findings were accepted as abstracts at Osteoarthritis Research Society International (OARSI) OARSI 2020 and published in the Osteoarthritis & Cartilage journal.
“The results from the patient survey provide an important reminder of the extraordinary toll knee OA takes on patients’ quality of life and underscore the need for effective disease management,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “To this end, these new analyses further establish the potential for ZILRETTA to provide meaningful and durable pain relief to these patients.”
Prospective Radiographic Analysis of the Effect of Single and Repeat Administrations of Intra-Articular Corticosteroids in Knee Osteoarthritis (Abstract 741)
An analysis of prospective radiographic data from the pivotal Phase 3 and the Phase 3b repeat administration trials assessed the effect of ZILRETTA and immediate-release triamcinolone acetonide in crystalline suspension (TAcs) injections in patients with symptomatic knee osteoarthritis (OA). Key findings show:
- No subchondral bone change, osteonecrosis, or radiographically documented rapidly progressive OA was identified in the 305 patients treated with ZILRETTA; and
- In 450 patients with knee OA who were treated with single or repeated doses of intra-articular corticosteroids there were no signs of osteonecrosis or chondrolysis observed over 6-12 months, and only one patient treated with TAcs showed evidence suggesting subchondral insufficiency fracture.
Fitbit®-Derived Evidence of Enhanced Mobility of Patients with Knee OA Treated with ZILRETTA: Results from a Phase 3b, Single-Arm, Open-Label (Abstract 745)
An analysis of 208 patients enrolled in the ZILRETTA Phase 3b, single-arm, open-label repeat administration study assessed the clinical benefit of treatment based on patient mobility defined as numbers of steps per day. The evaluation was conducted using a Fitbit, worn at least seven days prior to the first injection on Day 1 and through the end of Week 12 to measure step values. Key findings show:
- Patients treated with ZILRETTA exhibited improvement in mobility as shown by increases in weekly mean steps per day from Weeks 1-3 and change from baseline in weekly mean steps per day through Week 11;
- Patients treated with ZILRETTA exhibited a decrease in pain, with mean changes from baseline in WOMAC-A (pain) scores of -1.4, -1.2, and -0.8 at Weeks 4, 8, and 12, respectively; and1
- Greater change in step count from baseline was observed in association with larger decreases in WOMAC pain scores.
A Thousand Patient Voices: Knowledge, Impact, and Experiences of Living with OA of the Knee(Abstract 735)
An online survey of 1,041 patients (age ≥40 years) with physician diagnosed OAK was conducted by Harris Poll to examine patient attitudes and understanding of OAK, the effect it has on their overall health, limitations in function and social participation caused by OAK, and treatment experiences. Key survey findings include:
- Nearly all patients (95%) reported that OAK had a negative impact on their quality of life;
- Most patients (88%) felt that OAK had forced them to give up or negatively impacted one or more physical activities; particularly exercise or sport activities (85%);
- Patients acknowledged social and emotional consequences of OAK: 31% noted their self-esteem worsened, 29% reported feeling confined to their home, 24% noted feeling isolated from friends and family, and 21% responded that OAK made it difficult for them to maintain healthy relationships;
- Approximately 67% of patients indicated that they were concerned about their health, and 37% reported that OAK made it difficult for them to manage other health issues; and
- One third (33%) of survey respondents reported using opioids in the past to manage OAK pain, and 73% of those continued opioid use in the year before the survey.
These findings reveal opportunities for patient education about self-management and other treatment approaches.
Encores of these abstracts were also accepted at the American Medical Society for Sports Medicine annual meeting and published in the Clinical Journal of Sport Medicine.
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.
Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.
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.
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 2017, approximately 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, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) 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, the most common form of arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. Visit flexiontherapeutics.com.
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; 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 related to clinical trials, including potential delays, safety issues or negative results; risks related to key employees, markets, economic conditions, and health care reform; 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 filed with the SEC on March 12, 2020 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
Associate Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7137
jdowns@flexiontherapeutics.com
1. WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
