OA treatment for knee pain approved by FDA

February 28, 2014

FDA has approved hyaluronic acid (HA) injection (Monovisc, Anika Therapeutics), a single-injection supplement to synovial fluid of the osteoarthritic joint, for the treatment of pain and the improvement of joint mobility in patients with osteoarthritis (OA) of the knee.

FDA has approved hyaluronic acid (HA) injection (Monovisc, Anika Therapeutics), a single-injection supplement to synovial fluid of the osteoarthritic joint, for the treatment of pain and the improvement of joint mobility in patients with osteoarthritis (OA) of the knee.

Monovisc is the first FDA-approved single-injection product with HA from a non-animal source. It is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate-buffered saline.

Monovisc will be marketed in the United States by DePuy Synthes, Mitek Sports Medicine (Mitek), an orthopedic sports medicine company.

More than 5% of the world's population is afflicted by osteoarthritis of the knee, making it the most common joint disease. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. Risk factors include being overweight, joint injury, muscle weakness, having other forms of arthritis, and heredity. Approximately 10 million Americans currently suffer from OA of the knee and that number is expected to increase.

 

 

 

The FDA approval of Monovisc is based on safety and effectiveness data from a randomized, controlled, double-blind, multicenter US clinical study encompassing a total of 369 patients with OA of the knee at 31 centers in the United States and Canada . The objective of the study was to assess the safety and effectiveness of Monovisc for the treatment of joint pain. Patients were randomly assigned to either Monovisc or control (saline injection) and were evaluated for improvement in pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at follow-up assessments out to 26 weeks. The primary effectiveness analysis compared the proportion of Monovisc-treated patients achieving a greater improvement from baseline in WOMAC pain score versus control through 12 weeks. The safety analysis showed Monovisc had an extremely low rate of adverse events. There were no serious adverse events associated with the drug.

“It is important for patients with osteoarthritis of the knee to have access to treatments like Monvisc early in the continuum of care to help them maintain a healthy lifestyle,” said Mitek Sports Medicine spokesperson Christie Corbett.

A recent abstract presented at the American College of Rheumatology Annual Meeting found in a payer database review that patients who received HA injections delayed knee replacement by 2.6 years. In addition, research has shown that single-injection HA regimens may result in lower overall costs for the patient and healthcare system, according to Corbett.

“Unfortunately, many people wait too long to see a doctor and treat osteoarthritis of the knee,” she said. “Most of these people deal with the pain with over-the-counter pain medications, steroid injections, or just live in pain with limited mobility. These treatments provide only temporary relief for days or weeks and need to be taken frequently to provide consistent pain relief. As a result, more and more people who do not get adequate relief from pain medications and do not want to have surgery are turning to HA knee injections such as Monovisc. These products lubricate the knee, helping to relieve pain, improve mobility, and get the patient back to living an active life.”