FDA Approves Nuvo Research's PENNSAID 2%
By Cyndi Root
Nuvo Research Inc. announced in a press release that the Food and Drug Administration (FDA) has approved PENNSAID 2%. The medication treats osteoarthritis of the knee and the accompanying pain. PENNSAID 2% joins PENNSAID 1.5% and Nuvo Research’s topical pain and immunology products. Mallinckrodt has marketed PENNSAID 1.5% since 2010 and Nuvo has licensed the U.S. sales and marketing rights of PENNSAID 2% to Mallinckrodt. The company intends to market the drug right away.
Osteoarthritis of the Knee
Osteoarthritis of the knee is a painful and debilitating condition, especially in the later stages. Osteoarthritis is a very common form of knee arthritis. It progresses in stages as the joint cartilage slowly wears away. Older people are affected the most, but younger people can get it, too. Heredity often plays a factor, while injury, infection, or being overweight can be a causal factor.
Disease stages range from Stage 0 to Stage 4. Stage 0 is normal and no treatment is needed. Stage 1 shows minor bone spur growth with little to no discomfort or pain, but exercise and supplements like glucosamine and chondroitin are often recommended. Stage 2 is considered mild with more bone spurs, but healthy cartilage. Stage 3 is moderate, with cartilage deficits and pain when bending, walking, or running. Treatment choices are nonsteroidal anti-inflammatory drugs (NSAIDs), cortisone injections, or prescription pain medications. Stage 4 is severe with patients experiencing debilitating pain, as the cartilage is mostly gone.
PENNSAID 2%
PENNSAID 2% (diclofenac sodium) is a topical solution applied twice daily. PENNSAID is an NSAID, a class of drugs that increases risks of cardiovascular events and the risks increase the longer the patient uses the drug. NSAIDS can cause gastrointestinal problems like ulcers, bleeding, and stomach or intestinal perforations. Liver problems, hypertension, and dermatological problems may occur.
About Nuvo Research
Dan Chicoine, Chairman and Co-Chief Executive Officer of Nuvo Research said, “The approval of PENNSAID 2% is a significant milestone for Nuvo. We are pleased that the FDA has approved this product for patients suffering from the pain of osteoarthritis of the knee.” Nuvo markets PENNSAID 1.5%, a heated lidocaine/tetracaine patch (HLT Patch), and Pliaglis, a topical local anesthetic.