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

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

Efficacy and Safety of Meloxicam Co-Crystal and a Rapid-Absorption Formulation of Meloxicam in The Treatment of Post-Surgical Dental Pain. (PAINWeek 2024) - P2, P3 | "Subjects were permitted to use hydrocodone/acetaminophen 5/325 mg tablets as rescue treatment for pain.In both studies, the primary efficacy endpoint was the summed pain intensity difference over 0-24 hours (SPID0-24). 112 and 110 subjects were randomized and treated in studies 1 and 2, respectively; 110 subjects completed the in-patient portion of each study. In study 1, model-based mean SPID0-24 (95% CI) was 54.9 (38.2, 71.7), 89.6 (75.7, 103.5), 93.4 (84.8, 102.0), 95.6 (87.0, 104.3), 98.1 (85.0, 111.3) for placebo, MECC-SA 10 mg QD, 15 mg QD, 10 mg BID, and 15 mg BID respectively. In study 2, model-based mean SPID0-24 (95% CI) was 52.0 (36.4, 67.5), 70.7 (55.1, 86.3), 86.7 (77.0, 96.4), 94.8 (80.0, 109.6) for placebo, Meloxicam 1.25mg BID, 5mg BID, and 15mg BID respectively."

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

Efficacy and Safety of Meloxicam Co-Crystal and a Rapid-Absorption Formulation of Meloxicam in The Treatment of Post-Surgical Dental Pain (PAINWeek 2024) - P2, P3 | "This session is not certified for credit Studies described in this abstract:MECC-TBZ-2001 NCT04571515MELO-TFZ-2001 NCT05317312 Ongoing trials:MR-107A-02-TFZ-3001 NCT06215820MR-107A-02-TFZ-3002 NCT06215859 Background: Oral opioids continue to be a key component of post-surgical pain despite their well-described side effect profile and risk of abuse, misuse and diversion...Subjects were permitted to use hydrocodone/acetaminophen 5/325 mg tablets as rescue treatment for pain.In both studies, the primary efficacy endpoint was the summed pain intensity difference over 0-24 hours (SPID0-24)... 112 and 110 subjects were randomized and treated in studies 1 and 2, respectively; 110 subjects completed the in-patient portion of each study. In study 1, model-based mean SPID0-24 (95% CI) was 54.9 (38.2, 71.7), 89.6 (75.7, 103.5), 93.4 (84.8, 102.0), 95.6 (87.0, 104.3), 98.1 (85.0, 111.3) for placebo, MECC-SA 10 mg QD, 15 mg QD, 10 mg BID, and 15 mg BID respectively. In study..."

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

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy (clinicaltrials.gov) - P3 | N=405 | Recruiting | Sponsor: Mylan Specialty, LP

New P3 trial • Pain

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy (clinicaltrials.gov) - P3 | N=530 | Recruiting | Sponsor: Mylan Specialty, LP

New P3 trial • Pain

MELO-TFZ-2001: Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain. (clinicaltrials.gov) - P2 | N=111 | Completed | Sponsor: Mylan Specialty, LP | Recruiting ➔ Completed

Trial completion • Pain