Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06215820 | Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy | PHASE3 | COMPLETED | 410 | — | — | Dec 29, 2023 | Sep 30, 2024 | Oct 14, 2025 | 15 | United States |
| NCT06215859 | Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy | PHASE3 | COMPLETED | 579 | — | — | Dec 29, 2023 | Mar 12, 2025 | Feb 10, 2026 | 18 | United States |
| NCT05317312 | Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain. | PHASE2 | COMPLETED | 111 | — | — | Mar 31, 2022 | Jun 20, 2022 | Aug 7, 2023 | 1 | United States |
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
| Arm | Type | Description |
|---|---|---|
| MR-107A-02 | EXPERIMENTAL | 15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) . |
| Tramadol | ACTIVE_COMPARATOR | 50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization). Placebo will be administered during out patient phase. |
| Placebo | PLACEBO_COMPARATOR | Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase. |
| MR-107A-02 1.25 mg twice in a 24 hour period | EXPERIMENTAL | Oral tablet, one day of dosing |
| MR-107A-02 5 mg twice in a 24 hour period | EXPERIMENTAL | Oral tablet, one day of dosing |
| MR-107A-02 15 mg twice in a 24 hour period | EXPERIMENTAL | Oral tablet, one day of dosing |
| Placebo twice in a 24 hour period | PLACEBO_COMPARATOR | Oral tablet, one day of dosing |
| Name | Type | Description |
|---|---|---|
| MR-107A-02 | DRUG | tablet |
| Tramadol | DRUG | over-encapsulated tablet |
| Placebo | DRUG | over-encapsulated tablet and/or tablet |
| Bunionectomy | PROCEDURE | Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia |
| Herniorrhaphy | PROCEDURE | Unilateral open inguinal herniorrhaphy with mesh under general anesthesia |
Key Inclusion Criteria: 1. Requirement for a primary unilateral bunionectomy 2. Has an American Society of Anesthesiologists Physical Status of I, II, or III. 3. Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal scia...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |