General Information

Vimovo is a fixed-dose combination of the proton pump inhibitor esomeprazole magnesium, with the nonsteroidal anti-inflammatory drug (NSAID) naproxen in a single tablet.

Vimovo is specifically indicated 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.

Mechanism of Action

Vimovo is a fixed dose combination of the proton pump inhibitor esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen in a single tablet. Vimovo has been developed as a delayed release tablet whereby esomeprazole (20 mg) is released first in the stomach, prior to the dissolution of enteric-coated naproxen (500 mg) in the small intestine. The mechanism of action of the naproxen, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Side Effects

Adverse events associated with the use of Vimovo may include, but are not limited to, the following:

• Erosive gastritis
• Dyspepsia
• Gastritis
• Diarrhea
• Gastric ulcer
• Upper abdominal pain
• Nausea

Dosing/Administration

Vimovo is supplied as a tablet for oral administration. The recommended initial dose is one tablet twice daily of 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Vimovo is to be taken at least 30 minutes before meals.

Clinical Trial Results

FDA Approval
The FDA approval of Vimovo was based on the following studies:
 

Gastric Ulcers
Two randomized, multicenter, double-blind trials (Study 1 and Study 2) compared the incidence of gastric ulcer formation in 428 patients taking Vimovo and 426 patients taking enteric-coated naproxen. Vimovo given as 500 mg/20 mg twice daily statistically significantly reduced the six-month cumulative incidence of gastric ulcers compared to enteric-coated naproxen 500 mg twice daily: Study 1 9 percent versus 50 percent, respectively and Study 2 15 percent versus 51 percent, respectively (p < 0.001 for both studies).
 

Signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
Two 12-week randomized, double-blind, placebo-controlled trials enrolled patients with osteoarthritis (OA) of the knee. Vimovo was given as 500 mg/20 mg twice daily. In each trial, patients receiving Vimovo had significantly better results compared to patients receiving placebo as measured by change from baseline of the WOMAC pain subscale and the WOMAC physical function subscale and a Patient Global Assessment Score.
 

Based on studies with enteric-coated naproxen, improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling, a reduction in duration of morning stiffness, a reduction in disease activity as assessed by both the investigator and patient and by increased mobility as demonstrated by a reduction in walking time. In patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest.