-New Treatment Option is Potential Alternative to OTC Pain Medications- SAN FRANCISCO, March 9, 2004 —
Ortho Biotech Products, L.P., today introduced ORTHOVISC® (High Molecular Weight Hyaluronan), a new treatment option for patients suffering from pain due to osteoarthritis (OA) of the knee, at the annual meeting of the American Academy of Orthopedic Surgeons. Osteoarthritis is one of the most common causes of physical disability among adults, and the knee is one of the most commonly affected joints. According to data from the First National Health and Nutrition Examination Survey, OA of the knee affects as many as 50 percent of people aged 45 to 74 years in the United States. In severe cases, OA of the knee can lead to disability and may require surgery to replace the knee joint.
"ORTHOVISC is a safe, effective, non-surgical option when over-the-counter pain relievers no longer work," said David H. Neustadt, M.D., FACP, MACR, Clinical Professor of Medicine, University of Louisville School of Medicine. Approved by the U.S. Food and Drug Administration in February, ORTHOVISC is now available to patients through physicians' offices. It is an injectable form of ultra-pure hyaluronic acid that can be given in a series of three weekly injections into the knee joint.
The hyaluronan used in ORTHOVISC is similar to healthy human synovial fluid, a substance that lubricates the knee joint. In one clinical trial, the three-injection regimen of ORTHOVISC demonstrated effectiveness in reducing pain by 58 percent, compared to 40 percent for patients receiving saline injections. "There was significant pain reduction in patients using the ultra-pure hyaluronic ORTHOVISC regimen," said Dr. Neustadt. "We also were pleased to see few side effects in the clinical trials."
ORTHOVISC 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 to simple analgesics, such as acetaminophen. Other treatments for pain associated with OA include nonsteroidal anti-inflammatory drugs, intra-articular steroids and surgery.
In clinical studies the most commonly reported adverse events were arthralgia, back pain and headache. Other side effects included local injection site adverse events. ORTHOVISC is contraindicated in patients with known hypersensitivity to hyaluronate formulations or known avian or avian-derived allergies including eggs. ORTHOVISC should not be injected in patients with infections or skin diseases in the area of the injection site or joint. Strict aseptic technique should be used. The safety and effectiveness of less than three injections, or more than one course, have not been established.
About Ortho Biotech Products, L.P. Ortho Biotech licensed the U.S. rights to ORTHOVISC from Anika Therapeutics, Inc. (Nasdaq: ANIK – News) in December 2003. Ortho Biotech was established in Raritan, N.J. in 1990 as the first biotechnology subsidiary of Johnson & Johnson. Now located in Bridgewater, N.J., the company and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative healthcare products that extend and enhance the quality of patients' lives. Note: for full prescribing information, please visit www.orthovisc.com.