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All Primary and Secondary Endpoints Were Met in Both Phase 3 Studies
In Both Acute Pain Models, MR-107A-02 Demonstrated Statistically Significant and Clinically Meaningful Improvement in Pain Compared to Placebo, Significant Reduction in Opioid Usage and Superior Pain Control Versus the Opioid Arm
Targeting New Drug Application Submission to U.S. FDA by End of 2025
PITTSBURGH , May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS ), a global healthcare company, today announced positive results from its Phase 3 program of the novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain. 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 trials evaluated the efficacy and safety of MR-107A-02 versus placebo and included an opioid comparator 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 (SPID 0-48h ). 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, MR-107A-02 demonstrated statistically significant and clinically meaningful results. In particular:
"Building on an established mechanism of action and well-characterized safety profile, the efficacy and benefit-risk profile observed in these two pivotal studies optimally positions our fast-acting meloxicam for potential first-line treatment of moderate-to-severe acute pain," said Viatris Chief R&D Officer Philippe Martin . "The data observed in two surgical models – herniorrhaphy and bunionectomy – is a critical step in the development of a safe and effective non-opioid option to address an important public health need."
"I have accompanied this project since the Phase 2 dental pain study in 2022, and it is rare to see such positive data replicated in three different trials," said Dr. Todd Bertoch , a board-certified anesthesiologist, and the Chief Medical Officer for Pain Research at CenExel. "The efficacy and safety data of the novel, fast-acting meloxicam (MR-107A-02) from two Phase 3 studies in both bony and soft tissue pain models supports its potential use as a powerful, first-line, non-opioid analgesic option for patients with moderate-to-severe acute pain – potentially eliminating opioid use altogether for many patients."
The Company is targeting to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of 2025 based on the positive data from these two Phase 3 studies and the supportive positive Phase 2 dose range finding data in dental pain.
Full results from both Phase 3 studies will be submitted for presentation at future congresses, including the upcoming PAINWeek 2025 conference in September.
Additional information about the positive Phase 3 studies will be made available in the Company's Q1 2025 Earnings Presentation that can be found at https://investor.viatris.com/events-and-presentations .
Phase 3 Trial Design for Herniorrhaphy (NCT06215859) and Bunionectomy ( NCT06215820) Post-operative herniorrhaphy and bunionectomy patients aged 18 or older who experienced moderate-to-severe pain following surgery were eligible to participate in the trials, NCT06215859 and NCT06215820, respectively. 579 herniorrhaphy subjects and 410 bunionectomy subjects were randomized and received doses of either MR-107A-02 , tramadol or placebo every six hours during the inpatient phase (0-48h, 8 doses of study drug). To maintain the blind, subjects in the inpatient MR-107A-02 group received MR-107A-02 active and MR-107A-02 placebo alternately to allow for a six-hour dosing regimen of all subjects. During the outpatient phase, subjects continued to receive dose of the study drug twice daily (5 days, 10 doses of study drug). Subjects randomized to receive tramadol during the inpatient phase received placebo in the outpatient phase.
About Acute Pain Acute pain is defined as pain of sudden onset associated with a known cause—such as surgery, trauma, or acute illness—and is typically self-limiting, resolving within 30 days to three months. It affects more than 80 million individuals in the U.S. each year and is a primary driver of emergency department visits and postoperative morbidity. Clinically, it contributes to delayed recovery, impaired physical function, poor sleep, and reduced quality of life. Economically, the burden of acute pain is substantial, including both direct medical expenses and indirect costs such as lost productivity and disability. Societally, inadequate pain control affects patient satisfaction and rehabilitation outcomes, contributes to opioid prescribing and potential misuse. Despite the widespread impact, more than half of surgical patients report inadequate pain relief, reflecting a significant unmet need for effective, non-opioid treatment options with rapid onset and favorable safety profiles.
About Viatris Viatris Inc. (Nasdaq: VTRS ) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh , Shanghai and Hyderabad, India . Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X (formerly Twitter).
SOURCE Viatris Inc.