fast-acting meloxicam (MR-107A-02) / Viatris - LARVOL DELTA

MR-107A-02 Demonstrates Significant Analgesic Benefit in Both Moderate and Severe Postoperative Pain: A Post-Hoc Subgroup Analysis of Two Phase 3 Studies (PAINWeek 2026) - "Background: MR-107A-02 is a novel, fast-absorbing meloxicam that has demonstrated efficacy and safety in Phase 3 trials in patients with moderate or severe postoperative pain... Patients reporting pain scores ≥4 on NRS-R and/or NRS-A were randomized to receive MR-107A-02 (15 mg BID), placebo, or tramadol (50 mg QID) in bunionectomy and herniorrhaphy studies... Across both studies,192 patients presented with moderate pain and 536 with severe pain at baseline. MR-107A-02 significantly improved SPID 0-48 versus placebo across both pain subgroups. In bunionectomy, MR-107A-02 demonstrated a LS mean SPID 0-48 of 134.94 vs 67.40 in moderate pain (LSMD: 67.54; p =0.001) and 202.25 vs 112.0 in severe pain (LSMD: 90.25; p < 0.001)."

P3 data • Retrospective data • CNS Disorders • Pain

Improvement in Pain and Functional Outcomes during the first 24 hours with Fast-Absorbing Meloxicam Following Surgery: Results from Two Phase 3 Studies (PAINWeek 2026) - "Comparisons were performed versus placebo and the active control tramadol to further characterize the early clinical benefits of MR-107A-02 in patients experiencing moderate-to-severe acute postoperative pain. A total of 410 patients undergoing bunionectomy and 579 patients undergoing herniorrhaphy were randomized, with study completion rates exceeding 95% in both trials. Baseline pain severity was comparable across treatment groups. At 24 hours after first study drug administration, MR-107A-02 demonstrated statistically significant improvements in pain reduction versus placebo across both surgical models."

P3 data • Surgery • CNS Disorders • Pain

MR-107A-02 in Acute Postoperative Pain Management Following Bunionectomy: Results from a Multicenter, Placebo- and Active-Controlled, Phase 3 Trial. (PubMed, Pain Ther) - P3 | "MR-107A-02 provided statistically significant analgesic efficacy, faster onset of action, good tolerability, and reduced opioid rescue medication compared with placebo, highlighting its opioid-sparing potential. These findings should be interpreted within the constraints of the bunionectomy model, and confirmation in broader surgical settings is warranted."

Clinical • Journal • P3 data • Pain

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-02 in the Treatment of Post-Surgical Dental Pain. (PubMed, Pain Med) - "MR-107A-02 was generally well tolerated and demonstrated dose-dependent efficacy, with the 15 mg BID dose providing rapid analgesia and a reduction in rescue medication use."

Clinical • Journal • Pain

U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain (PRNewswire) - " The FDA has assigned a PDUFA goal date of Dec. 27, 2026....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)."

FDA filing • PDUFA • Pain

Opioid sparing effect of MR-107A-02 for the treatment of acute moderate-to-severe pain following bunionectomy and herniorrhaphy (ASRA-SPRING 2026) - "Opioid Sparing Effect of MR-107A-02, A Novel Fast-Acting Meloxicam Formulation for the Treatment of Acute Moderate to Severe Pain Following Bunionectomy and Herniorrhaphy"

Pain

Efficacy and safety of MR-107A-02 (novel meloxicam formulation) for treatment of acute moderate-to-severe pain after herniorrhaphy (ASRA-SPRING 2026) - "Efficacy and Safety of MR-107A-02, a Novel Fast-Acting Formulation of Meloxicam, for the Treatment of Acute Moderate-to-Severe Pain Following Herniorrhaphy"

Clinical • Pain

Pharmacokinetic comparison of MR-107A-02 (novel meloxicam) 15mg tablet with meloxicam (Mobic®) 15mg in healthy adult male subjects (ASRA-SPRING 2026) - "Comparison of the Pharmacokinetics of a Novel, Fast-Acting Oral Formulation of Meloxicam, MR-107A-02, versus Mobic® in Healthy Adult Human Subjects"

Clinical • PK/PD data

Efficacy and safety of MR-107A-02 (novel meloxicam formulation) for treatment of acute moderate-to-severe pain after bunionectomy (ASRA-SPRING 2026) - "Efficacy and Safety of MR-107A-02, a Novel Fast-Acting Formulation of Meloxicam for the Treatment of Acute Moderate-to-Severe Pain Following Bunionectomy"

Clinical • Pain

Efficacy of MR-107A-02 in Acute Moderate and Severe Postoperative Pain: A Post-Hoc Analysis of Two Phase 3 Trials (PainConnect 2026) - No abstract available

Clinical • P3 data • Retrospective data • Pain

Comparison of the pharmacokinetics of MR-107A-02, a novel fast-acting formulation of meloxicam, versus standard meloxicam reference: a phase I study. (PubMed, Expert Opin Drug Deliv) - "MR-107A-02 demonstrated more rapid absorption than reference, as evidenced by a higher Cmax, and shorter Tmax values. These findings highlight the potential utility of oralMR-107A-02's fast-release design in an acute pain setting."

Journal • P1 data • PK/PD data • Pain

Time to Efficacy Onset of MR-107A-02 (Novel Fast-Acting Meloxicam Formulation) in the Treatment of Acute Postoperative Pain Following Bunionectomy and Herniorrhaphy (PAINWeek 2025) - P2, P3 | "Background: Meloxicam is a member of the non-steroidal anti-inflammatory drugs (NSAIDs) group of medications, shown to exhibit anti‑inflammatory and analgesic activity in clinical studies. This poster will present additional post-hoc analyses that further confirm the superior pain control provided by MR‑107A‑02 in both surgical models, including an analysis of the time to 2-point reduction in the NRS. In bunionectomy, MR-107A-02 demonstrated a statistically significant difference in the time to 2-point reduction in the NRS-R when compared to placebo, along with a shorter median time to 2-point reduction in the NRS-R, in comparison to Tramadol. Similar results were seen for herniorrhaphy, where the difference in the time to 2-point reduction in the NRS-A versus placebo was highly statistically significant."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Pain

Pharmacokinetics study comparing MR-107A-02 (novel fast-acting meloxicam formulation) 15mg tablet with meloxicam (Mobic®) 15mg in healthy adult male subjects (PAINWeek 2025) - "Of the 18 randomized (9 MR-107A-02, 9 Mobic®; all participants were Asian, males; mean [SD] age, 32 [6] years; mean [SD] weight, 57.8 [5.3] kg) subjects, 16 participants completed the study. Two participants withdrew from the study due to personal reasons. MR-107A-02 demonstrated a more rapid absorption with a C max value of 2734.342 (ng/mL) compared to Mobic® 1592.102 (ng/mL) and a significantly shorter T max (hour) (0.958 vs 4.656)."

Clinical • PK/PD data • CNS Disorders

Opioid sparing effect of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy and herniorrhaphy (PAINWeek 2025) - "In both studies, comparisons between MR-107A-02 and placebo included the number and proportion of subjects using acetaminophen and opioid (oxycodone and/or morphine) rescue medication, the mean number of doses, number of times of usage, time to first opioid use, and proportion of opioid free subjects. Of 410 randomized participants (137 MR-107A-02, 136 placebo,137 tramadol; 85.9% females; 60% whites; mean [SD] age, 48 [13.4] years; weight range, 45-126 kg), 397 participants completed the bunionectomy study. The baseline NRS-R (mean [SD]) were similar across all three groups (7.2 [1.67] MR-107A-02, 7.6 [1.73] placebo, 7.2 [1.64] tramadol). In the herniorrhaphy study, 579 participants were randomized (232 MR-107A-02, 231 placebo,116 tramadol; 96.3% males; 84 % whites; mean [SD] age, 49.1 [12.21] years; weight range, 44-152 kg), and 551 participants completed the study."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Pain • Psychiatry

Efficacy and safety of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy (PAINWeek 2025) - "Background: Effective treatment of acute moderate-to-severe pain is critically important. Of the 410 randomized participants (137 MR-107A-02, 136 placebo,137 tramadol; 85.9% females; 60% whites; mean [SD] age, 48 [13.4] years; weight range, 45-126 kg), 397 participants completed the study. Baseline NRS-R scores (mean [SD]) were similar across all the three groups (7.2 [1.67] MR-107A-02, 7.6 [1.73] placebo and 7.2 [1.64] tramadol). The primary endpoint SPID 0-48 (NRS-R), comparing MR-107A-02 to placebo, was met."

Clinical • CNS Disorders • Musculoskeletal Pain • Pain

Efficacy and safety of MR-107A-02 (novel meloxicam fast-acting formulation) for the treatment of acute moderate-to-severe pain following herniorrhaphy (PAINWeek 2025) - "Background: Managing acute pain is crucial. Of 579 randomized participants (232 MR-107A-02, 231 placebo,116 tramadol; 96.3% males;84 % whites; mean [SD] age, 49.1 [12.21] years; weight range, 44-152 kg), 551 participants completed the study. The baseline NRS-A scores (mean [SD]) were similar across all three groups (7.8 [1.66] MR-107A-02, 7.7 (1.68) placebo, 7.8 [1.57] tramadol). The primary endpoint SPID 0-48 (NRS-A), for MR-107A-02 versus placebo, was met."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Pain

(Scientific Abstract Presentation) Opioid sparing effect of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy and herniorrhaphy (PAINWeek 2025) - "Sponsored By VIATRIS This presentation is sponsored by Viatris and is not certified for credit."

CNS Disorders • Pain

(Scientific Abstract Presentation) Efficacy and safety of MR-107A-02 (novel meloxicam fast-acting formulation) for the treatment of acute moderate-to-severe pain following herniorrhaphy (PAINWeek 2025) - "Sponsored By VIATRIS This presentation is sponsored by Viatris and is not certified for credit."

Clinical • CNS Disorders • Pain

(Scientific Abstract Presentation) Efficacy and safety of MR-107A-02 (novel fast-acting meloxicam formulation) for the treatment of acute moderate-to-severe pain following bunionectomy (PAINWeek 2025) - "Sponsored By VIATRIS This presentation is sponsored by Viatris and is not certified for credit."

Clinical • CNS Disorders • Pain

(Scientific Abstract Presentation) Pharmacokinetics study comparing MR-107A-02 (novel fast-acting meloxicam formulation) 15mg tablet with meloxicam (Mobic®) 15mg in healthy adult male subjects (PAINWeek 2025) - "Sponsored By VIATRIS This presentation is sponsored by Viatris and is not certified for credit."

Clinical • PK/PD data • CNS Disorders

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 (PRNewswire) - P3 | N=579 | NCT06215859 | N=410 | NCT06215820 | Sponsor: Viatris Specialty LLC | "The Phase 3 program consisted of two randomized...active-controlled trials...Treatment with MR-107A-02 led to improvement in pain versus baseline compared to placebo (herniorrhaphy: LS mean difference in SPID0-48h between MR-107A-02 and placebo = 50.1 (95% CI: 35.4, 64.8; p<0.001); bunionectomy: LS mean difference in SPID0-48h between MR-107A-02 and placebo = 82.7 (95% CI: 62.0, 103.4; p<0.001)); MR-107A-02 demonstrated notable reduction in opioid usage over the entire treatment phase by reducing opioid use versus placebo and by showing a higher number opioid-free patients than placebo...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....Phase 2 dose range finding data in dental pain."

FDA filing • P3 data: top line • Pain

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy (clinicaltrials.gov) - P3 | N=579 | Completed | Sponsor: Mylan Specialty, LP | Active, not recruiting ➔ Completed

Trial completion • Pain

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy (clinicaltrials.gov) - P3 | N=579 | Active, not recruiting | Sponsor: Mylan Specialty, LP | Recruiting ➔ Active, not recruiting

Enrollment closed • Pain

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=410 | Completed | Sponsor: Mylan Specialty, LP | Active, not recruiting ➔ Completed

Trial completion • Pain

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=410 | Active, not recruiting | Sponsor: Mylan Specialty, LP | Recruiting ➔ Active, not recruiting

Enrollment closed • Pain