VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a proton pump inhibitor (PPI), indicated for the relief of signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Twenty-seven million Americans are affected by osteoarthritis, which is the most common form of arthritis. While many patients with osteoarthritis treat their symptoms with NSAIDS, adverse gastrointestinal events affect 25-50% of chronic NSAID users. VIMOVO is an important new treatment option that aligns with the current recommendations of the American College of Gastroenterology and the American College of Rheumatology’s Ad Hoc Group on the use of selective and non-selective NSAIDs for patients who are at risk to develop gastric ulcers but who need to take an NSAID.
The U.S. Food and Drug Administration (FDA) approval of VIMOVO is supported by data from a comprehensive clinical trials program, including results from the six-month studies PN400-301 and PN400-302 studies. In the PN400-301 and 302 studies, the primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, patients received either VIMOVO or enteric-coated naproxen (500 mg), twice daily, over a six-month treatment period. Endoscopies were performed at baseline and at one, three and six months. Data from study PN400-301 showed a 4.1 percent incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1 percent among patients taking enteric-coated naproxen (p<0.001). Study PN400-302 showed a 7.1 percent incidence of gastric ulcers among patients taking VIMOVO, compared to 24.3 percent with enteric-coated naproxen (p<0.001).
On April 30, 2010, the FDA notified POZEN that it had approved VIMOVO delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
VIMOVO received positive agreement for approval in 23 countries across the European Union in October 2010, which was followed by marketing and pricing approval in the United Kingdom, the first major ex-U.S. territory. VIMOVO has now been launched in more than 28 countries with more anticipated in 2012. In June 2010, POZEN officially transferred to AstraZeneca the Investigational New Drug (IND) and NDA for the product. AstraZeneca is responsible for the commercialization of VIMOVO.
In November 2013, AstraZeneca AB and Horizon Pharma USA, Inc. entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO. Under the terms of the agreement, POZEN will continue to receive a 10% royalty on Net Sales of products sold in the United States, with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided that the patents owned by POZEN which cover VIMOVO are in effect and no generic forms of VIMOVO are on the market. AstraZeneca will continue to have rights to commercialize VIMOVO outside of the United States.
For Full Prescribing Information, please visit www.VIMOVO.com.