Ferring Pharmaceuticals and Savient Pharmaceuticals' Euflexxa

Patients with pain from osteoarthritis of the knee have a new treatment option for their pain. Ferring Pharmaceuticals, in combination with Savient Pharmaceuticals, has released Euflexxa (1% sodium hyaluronate), the first non-avianderived biologic formulation of hyaluronic acid.¹ Unlike other avian-derived products, Euflexxa can be used without the potential for allergic reactions in patients with poultry, feather, or egg allergies. Additionally, it is promoted as a high-purity hyaluronan with properties similar to those found in human fluids.²

Osteoarthritis is estimated to affect 66 million Americans. The condition occurs when cartilage in the joint wears away, causing the bones of the joint to rub against each other. Its symptoms include pain, stiffness, and decreased joint mobility. Symptoms in the knee are reported most frequently. Osteoarthritis treatments include lifestyle modification, oral pain medications, intra-articular injections, and kneereplacement surgery.²

Euflexxa is indicated for the treatment of knee pain from osteoarthritis in adults who have not responded to nonpharmacologic interventions and simple analgesics such as acetaminophen. Euflexxa is given as a 2-mL intra-articular injection once a week for 3 weeks.³

Pharmacology

Hyaluronan is a naturally occurring substance in human joints. Its high viscosity and elasticity help to lubricate joints, maintain cartilage, and absorb shock. Arthritic joints, however, may be lacking the appropriate hyaluronan to maintain joint health. Euflexxa works to replace both the quality and the quantity of hyaluronan that may be missing in osteoarthritic patients.^2,3

Clinical Trial

A multicenter, prospective, randomized, double-blind, active-control study evaluated Euflexxa against another commercially available hyaluronan product. The study was aimed to determine noninferiority for Euflexxa, compared with the already-available hyaluronan product. Pain self-assessments were based on walking on a flat surface, going up and down stairs, resting during the night, sitting or lying, and standing upright. A total of 160 patients were randomized to receive Euflexxa; 161 other patients received the active-control product. Each group received 3 once-weekly injections at the beginning of the study.

After 12 weeks, the researchers found that pain relief in all 5 pain parameters in the Euflexxa group was comparable to that in the control group. Thus, they deemed Euflexxa noninferior to the commercially available hyaluronan product.³ Additionally, more patients in the Euflexxa group reported being pain-free than in the active-control group at the study's end.²

Safety

Euflexxa should not be used in patients with a known hypersensitivity to any of its components. Clinicians should avoid using Euflexxa in patients with infections of the knee joint or the skin in the area of the knee. Euflexxa is not approved for use in patients who are pregnant, breast-feeding, or under 18 years of age.³

Transient side effects with Euflexxa include pain, swelling, skin irritation, and tenderness. More serious reactions may include back pain, an increase in blood pressure, fatigue, nausea, and burning, itching, or tingling. Patients experiencing a serious reaction should contact their health care provider immediately.³

Patient Education

Patients should be advised to avoid demanding weight-bearing activities that last for more than 1 hour for 48 hours after the injection. Examples of activities to avoid include jogging, tennis, lifting, or prolonged standing.

To decrease pain from osteoarthritis, patients should avoid activities that are bothersome to the knee joint. Other tips include engaging in exercise or physical therapy and using appropriate analgesic and/or anti-inflammatory medications.³

Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz.

For a list of references, send a stamped, selfaddressed envelope to: References Department, Attn. A. Rybovic, Pharmacy Times, Ascend Media Healthcare, 103 College Road East, Princeton, NJ 08540; or send an e-mail request to: arybovic@ascendmedia.com