Rheumatoid Arthritis Drug, Vimovo Delayed-Release Tablets, Approved for US Patent

Rheumatoid Arthritis Drug, Vimovo Delayed-Release Tablets, Approved for US Patent

Horizon Pharma has received a Notice of Allowance from the U.S. Patent and Trademark Office for its application covering Vimovo tablets, a fixed-dose combination of delayed-release enteric-coated naproxen (a non-steroidal anti-inflammatory drug, or NSAID), and immediate-release esomeprazole magnesium (a stomach acid-reducing proton pump inhibitor, or PPI). Vimovo is a U.S.-approved medicine indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults.

The tablets are also approved for adult patients at risk of developing NSAID-associated gastric ulcers.

The patent (application number 14/954,082), is expected to be issued shortly and will run through May 31, 2022, Horizon said in a company press release. After issuance, Horizon and Aralez Pharmaceuticals plan to list the drug in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, the so-called Orange Book.

Common side effects of Vimovo include inflammation of the stomach lining, indigestion, diarrhea, stomach ulcers, abdominal pain, and nausea.

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disease that usually affects the lining of joints (synovial membrane), but can also affect organs, causing disability, and lowering a person’s quality of life.

Although there is no cure for RA, drugs are increasingly available to treat the disease and prevent deformed joints. Early, aggressive treatment can delay joint destruction, and usually includes multiple drug therapies taken concurrently. Disease modifying anti-rheumatic drugs, or DMARDs, are the current standard of care for RA therapy, in addition to rest, strengthening exercise, and anti-inflammatory drugs.

RA patients may take a combination of a DMARD, an oral glucocorticoid, an NSAID and/or a biologic agent. Most patients, however, are treated with DMARDs, such as methotrexate, which are typically used as an initial therapy. Biologic agents are typically added to DMARDs as a combination therapy.

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