Dual-acting EUFLEXXA: Robust study design. Statistically significant results.2,3

The efficacy and safety of EUFLEXXA was studied across 3 robust clinical trials2,3

Compared to Synvisc, EUFLEXXA delivered:

Powerful pain relief 2,3

Primary Endpoint

of EUFLEXXA patients were PAIN-FREE at the end of the 12-week study3
*Change from baseline in VAS (100-mm scale) for the average of 5 WOMAC scores. Both treatment groups demonstrated statistically significant and clinically meaningful improvements from baseline (P<0.0001).
Pain-free is defined as symptom-free for the 5 WOMAC pain questions (with average visual analog scale [VAS] scores of <20mm).

Secondary Endpoints

Acetaminophen was the only rescue medication provided.

Most common adverse events (AEs) in 12-week pivotal trial vs Synvisc2,3

Incidence of AEs Reported by >5% of Patients

Compared to the control group, EUFLEXXA delivered:

Powerful pain relief2,4

Primary Endpoint

EUFLEXXA was proven superior to saline in reducing OA knee pain2,4

of EUFLEXXA patients were PAIN-FREE at 6 months2,4

Pain-free (<20 mm) was determined at week 26 using the 100 mm VAS based on the 50-foot walk test.

Better results when treated early

Secondary Endpoint

Most common AEs in 26-week FLEXX trial2

Treatment-emergent AEs by preferred term with an incidence of >3% of patients among
the treatment groups
Better results when treated early

Primary Endpoint

Post-hoc analyses are limited by their post-hoc design and thus prone to increased bias. Such analyses are exploratory and should not be used to infer causative relationships between variables.

Most common AEs in 26-week FLEXX Extension trial2

Treatment-emergent AEs by preferred term with an incidence of >3% of patients
among the treatment groups

§KL=Kellgren-Lawrence grading scale; KL grades are determined radiographically. KL-2 (n=235), KL-3 (n=353).
All numbers rounded to the nearest whole number.

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Safety

Explore the demonstrated
safety profile of EUFLEXXA.

Discover the Safety Profile
  1. Rolling 12 month average of IQVIA claims data based on unique patients (December 2022).
  2. EUFLEXXA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
  3. Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14(2):154-162.
  4. Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX Trial). Semin Arthritis Rheum. 2009;39(1):1-9.
  5. Altman RD, Rosen JE, Bloch DA, et al. Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial. Osteoarthritis Cartilage. 2011;19(10):1169-1175.

Please see Important Safety Information and Full Prescribing Information

Indication

EUFLEXXA® [1% sodium hyaluronate] is indicated for the treatment of pain in osteoarthritis [OA] of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics [eg, acetaminophen].

Important Safety Information

  • EUFLEXXA is contraindicated in patients who have a known hypersensitivity to hyaluronate preparations or who have knee joint infections, infections, or skin disease in the area of the injection site.
  • EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use skin disinfectants for skin preparation that contain quaternary ammonium salts.
  • Do not inject intravascularly due to potential for systemic adverse events.
  • The safety and effectiveness of injection in conjunction with other intra-articular injectables, or into joints other than the knee have not been studied. Remove any joint effusion prior to injecting. Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
  • The most common adverse events related to EUFLEXXA injections reported in 12- and 26-week clinical studies were arthralgia, back pain, pain in extremity, musculoskeletal pain, and joint swelling. In an open-label extension of the 26-week clinical study with repeat series of injections, the most common adverse events related to EUFLEXXA at Week 52 were arthralgia and joint swelling.

Please see full Prescribing Information

Indication

EUFLEXXA® [1% sodium hyaluronate] is indicated for the treatment of pain in osteoarthritis [OA] of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics [eg, acetaminophen].

Important Safety Information

  • EUFLEXXA is contraindicated in patients who have a known hypersensitivity to hyaluronate preparations or who have knee joint infections, infections, or skin disease in the area of the injection site.
  • EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use skin disinfectants for skin preparation that contain quaternary ammonium salts.
  • Do not inject intravascularly due to potential for systemic adverse events.
  • The safety and effectiveness of injection in conjunction with other intra-articular injectables, or into joints other than the knee have not been studied. Remove any joint effusion prior to injecting. Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
  • The most common adverse events related to EUFLEXXA injections reported in 12- and 26-week clinical studies were arthralgia, back pain, pain in extremity, musculoskeletal pain, and joint swelling. In an open-label extension of the 26-week clinical study with repeat series of injections, the most common adverse events related to EUFLEXXA at Week 52 were arthralgia and joint swelling.

Please see full Prescribing Information

12-week pivotal trial design: EUFLEXXA vs Synvisc1,2

Primary Endpoint

Demonstrated noninferiority as measured by mean change from baseline to Week 12 in VAS (100-mm scale) score for the average of 5 WOMAC pain scores: climbing stairs, walking, rest during night, sitting, standing.

  • Only acetaminophen (up to 4g daily) was permitted for rescue analgesia; use was quantified through pill counts
  • Patients were evaluated at screening; at baseline (prior to the first injection); and at Weeks 1, 2, 3, 6, and 12 following the initial injection. Patients were asked to assess levels of pain, stiffness, and physical function
  1. EUFLEXXA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
  2. Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14(2):154-162.

FLEXX and FLEXX Extension trial design1-3

In the FLEXX trial, only acetaminophen (up to 4g daily) was permitted for rescue analgesia; use was quantified through pill counts in both FLEXX and FLEXX Extension trials.1-3

FLEXX TRIAL: 26-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND

Primary efficacy endpoint was mean change in OA knee pain score, following a 50-foot walk test* from baseline to Week 26 vs saline.

FLEXX EXTENSION TRIAL: 26-WEEK, OPEN-LABEL, EXTENSION TRIAL

Adverse events were recorded, and the effect of treatment on OA knee pain was evaluated following a 50-foot walk test.*

*Measured by a 100-mm VAS.

  1. EUFLEXXA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
  2. Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX Trial). Semin Arthritis Rheum. 2009;39(1):1-9.
  3. Altman RD, Rosen JE, Bloch DA, et al. Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial. Osteoarthritis Cartilage. 2011;19(10):1169-1175.

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Post-Hoc Analysis1

The effect of baseline KL* grade was one of the variables evaluated in this post-hoc analysis

Objective:

To identify potential predictors of response to IA-HA and help clinicians determine the most appropriate patients for IA-HA therapy for OA knee pain.

Method:

Data from patients receiving IA-HA in the FLEXX and FLEXX Extension trials were evaluated to identify factors that may predict either successful or less successful outcomes with respect to the outcome measures used in the trials.

Variables Evaluated

(baseline values)
  • Treatment received
  • Age
  • Body mass index
  • Sex
  • Alcohol Use
  • Smoking status
  • KL grading scale (radiographically determined OA severity)
  • WOMAC pain, stiffness, and disability scores
  • OA in contralateral knee
  • History of physical therapy, steroid injection, other injection, arthrocentesis, NSAID treatment
  • VAS pain

Post-hoc analyses are limited by their post-hoc design and thus prone to increased bias. Such analyses are exploratory and should not be used to infer causative relationships between variables.

*KL=Kellgren-Lawrence grading scale; KL grades are determined radiographically. KL-2 (n=235), KL-3 (n=353).

REFERENCE: 1. Altman RD, Farrokhyar F, Fierlinger A, et al. Analysis for prognostic factors from a database for the intra-articular hyaluronic acid (Euflexxa) treatment for osteoarthritis of the knee. Cartilage. 2016;7(3):229-237.

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