Drugs / MR-107A-02
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute pain | 2026-05-18 | “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.” viatris.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05317312 | Mar → Jun 2022 | — | Mylan Specialty, LP | Completed | Met primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT06215859 | Dec 2023 → Jan 2025 | — | Viatris Specialty LLC | Completed | Met primary |
| Phase 3 | NCT06215820 | Dec 2023 → Aug 2024 | — | Viatris Specialty LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (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. |
| 2025-05-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results 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 viatris.com ↗
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. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain viatris.com ↗ |
| 2025-08-01 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces Five Data Presentations on Novel Fast-Acting Meloxicam (MR-107A-02) at PAINWeek 2025 Conference viatris.com ↗ |
| 2025-05-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 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 viatris.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MR-107A-02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06215820 ↗ |
| Route | Oral | “MR-107A-02 oral tablet” NCT05317312 ↗ |