Viatris announced that the 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.
"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."
The NDA is supported by data from the Phase 3 program which was presented at PAINWeek 2025. The Phase 3 program consisted of two randomized, double-blind, placebo-(double-dummy) and active-controlled trials – one following herniorrhaphy surgery (NCT06215859) and one following bunionectomy surgery (NCT06215820).
Both Phase 3 trials evaluated the efficacy and safety of fast-acting meloxicam versus placebo and included an opioid arm (tramadol 50mg q6h) to confirm the sensitivity of the pain model. The primary endpoint in both trials was defined by the Sum of Pain Intensity Difference (SPID) based on the Numeric Rating Scale measured over 0-48 hours (SPID0-48h) versus placebo. Both trials evaluated the reduction in opioid usage that was defined by number of mean doses of opioid rescue medication and proportion of opioid-free patients over the combined in- and out-patient treatment phases. In both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action.
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