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U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026. Acute pain affects more than 80 million individuals in the United States each year, where opioids remain a commonly used treatment option.1,2
About this update from Viatris Inc.
[{"type":"text","content":"FDA PDUFA Goal Date Set for Dec. 27, 2026","length":41,"tagName":"p","attribs":{}},{"type":"text","content":"PITTSBURGH, May 18, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain. The FDA has assigned a PDUFA goal date of Dec. 27, 2026. Acute pain affects more than 80 million individuals in the United States each year, where opioids remain a commonly used treatment option.1,2","length":523,"tagName":"p"},{"type":"image","alt":"Viatris OUS Logo (PRNewsfoto/Viatris Inc.)","displaySize":"","headline":null,"caption":"Viatris OUS Logo (PRNewsfoto/Viatris Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":112,"url":"https://media.zenfs.com/en/prnewswire.com/c03b6c5b724244b6bb2d566254fd974b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/IYJQdsU8VO3xyKmgpYwF0g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5Nw--/https://media.zenfs.com/en/prnewswire.com/c03b6c5b724244b6bb2d566254fd974b","width":400,"height":112},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/mk9UUvU9Asn6ERnJPVeTmQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTE3OQ--/https://media.zenfs.com/en/prnewswire.com/c03b6c5b724244b6bb2d566254fd974b","width":400,"height":112}},"href":"https://mma.prnewswire.com/media/1983916/Viatris_OUS_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""FDA's acceptance of the New Drug Application for investigational fast-acting meloxicam takes us one step closer to bringing a potential non-opioid first-line treatment option to patients with moderate-to-severe acute pain, which will help address an important public health need in the United States," said Philippe Martin, Viatris Chief R&D Officer. "Fast-acting meloxicam is one of several value-added medicines in our pipeline. We are proud of the strength of the clinical profile supporting this program, which includes a fast speed of onset of action, strong and sustained analgesic efficacy with a significant reduction in opioid usage, together with an established mechanism of action and well characterized safety profile."","length":760,"tagName":"p"},{"type":"tex...