Viatris’ Meloxicam Formulation Demonstrates Efficacy in Post-Surgical Acute Pain

Image Credit: Adobe Stock Images/Damian

Topline results from two pivotal Phase III trials show that Viatris’ MR-107A-02 significantly reduced pain intensity compared to placebo (SPID0-48h) and outperformed tramadol in post-hoc analyses for both pain relief and speed of onset. The novel fast-acting meloxicam formulation is in development for moderate-to-severe acute pain following herniorrhaphy and bunionectomy surgeries.

According to the company, full results from the trial are expected to be released during a demonstration at future medical meetings, including the upcoming PAINWeek in September.¹

"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 Philippe Martin, chief R&D officer, Viatris, in a press release. "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."

The randomized, double-blind, placebo- and active-controlled, double-dummy trials for herniorrhaphy surgery (NCT06215859) and bunionectomy surgery (NCT06215820) included a total of 989 adult patients. Both trials evaluated the safety and efficacy of MR-107A-02.

Patients were randomly assigned to receive either MR-107A-02, tramadol, or placebo every six hours during the inpatient phase. During this phase, patients alternated between MR-107A-02 and placebo to maintain the six-hour dosing schedule. In the outpatient phase, patients received the treatment twice daily over the course of five days.

Results found that MR-107A-02 demonstrated a least squares mean difference in SPID0-48h of 50.1 after herniorrhaphy and 82.7 after bunionectomy (both p<0.001). Additionally, 72.6% of herniorrhaphy patients and 56.9% of bunionectomy patients treated with MR-107A-02 remained opioid-free, compared to 58.6% and 33.1% in the placebo groups, respectively.

Further, post-hoc analyses showed MR-107A-02 outperformed tramadol in overall pain control and achieved faster onset of perceptible and meaningful pain relief. The drug was reported to be well tolerated, with treatment emergent adverse events (TEAEs) found to be comparable in both groups post-surgery. Few TEAEs were reported and none led to death.¹

Alongside the clinical update, Viatris released its Q1 2025 financial results. The company generated $67 million in new product revenue and stated that it remains on track to deliver between $450 million and $550 million in new product revenue by the end of the year. Additionally, the company reported a US GAAP net loss of $3 billion, mainly due to a $2.9 billion non-cash goodwill impairment. Earnings before interest, taxes, depreciation, and amortization was $923 million, down 23% year-over-year, while adjusted earnings per share fell to $0.50, down 25%.²

"I have accompanied this project since the Phase II dental pain study in 2022, and it is rare to see such positive data replicated in three different trials," said Todd Bertoch, board-certified anesthesiologist, chief medical officer, pain research, CenExel, in the press release. "The efficacy and safety data of the novel, fast-acting meloxicam (MR-107A-02) from two Phase III 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."

Viatris hopes to have a New Drug Application submitted to the FDA by the end of the year based on the data as well as Phase II data in dental pain.¹

References

Viatris Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Novel Fast-Acting Meloxicam (MR-107A-02) for the Treatment of Moderate-to-Severe Acute Pain. PR Newswire. May 8, 2025. Accessed May 8, 2025. https://prnmedia.prnewswire.com/news-releases/viatris-announces-positive-top-line-results-from-two-pivotal-phase-3-studies-of-novel-fast-acting-meloxicam-mr-107a-02-for-the-treatment-of-moderate-to-severe-acute-pain-302449495.html

Viatris Reports First Quarter 2025 Results and Reaffirms 2025 Outlook. Viatris. May 8, 2025. Accessed May 8, 2025. https://investor.viatris.com/news-releases/news-release-details/viatris-reports-first-quarter-2025-results-and-reaffirms-2025