Horizon Pharma, Inc., a commercial stage, specialty pharmaceutical company, has made availability of Horizon-labelled VIMOVO (naproxen/ esomeprazole magnesium) delayed-release tablets for US physicians. The Company also expects to begin the commercial launch of Horizon-labeled VIMOVO with its primary care sales force on February 3, 2014.
"The availability of Horizon-labeled VIMOVO is a major milestone for us as we plan for our full commercial launch. We expect to complete hiring and training our expanded sales force this month and commence our launch of VIMOVO in early February," stated Timothy P Walbert, chairman, president and chief executive officer, Horizon Pharma. "Effective today, VIMOVO is now available via our co-pay programme and is also included in our Prescriptions-Made-Easy specialty pharmacy program, ensuring VIMOVO is available at a reasonable out-of-pocket cost to patients."
According to the Arthritis Foundation, more than 50 million adults (one in every five) in the US have doctor diagnosed arthritis. Arthritis prevalence increases with age with 50 percent of adults age 65 and older having some form of arthritis. By the year 2030, an estimated 67 million American adults will have arthritis.
NSAIDs are effective at providing pain and inflammation relief associated with OA and RA; however, there are significant upper GI-associated adverse events which can result from such treatments and patients with OA and RA taking NSAIDs are at increased risk for upper GI ulcers.
VIMOVO was approved by the FDA in April 2010, supported by data from two pivotal studies in which patients received either VIMOVO or enteric-coated naproxen 500 mg, twice daily, over a six-month treatment period. Data from one study (PN400-301) showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1% among patients taking enteric-coated naproxen (p < 0.001). A second study (PN400-302) showed a 7.1% incidence of gastric ulcers among patients taking VIMOVO, compared to 24.3% with enteric-coated naproxen (p < 0.001). Endoscopies were performed at baseline and at one, three and six months. The safety of VIMOVO was evaluated in clinical studies involving 2,317 patients (aged 27 to 90 years) and ranging from 3-12 months. The most commonly observed adverse events in the clinical trials (experienced by > 5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea.
VIMOVO (naproxen / esomeprazole magnesium) is a proprietary fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID) and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved 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.