Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
107A-02 · 3 trials · 3 indications
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 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
107A-02 is an investigational small molecule being developed for the treatment of acute pain, including post-operative pain following surgical procedures such as dental surgery, bunionectomy, and herniorrhaphy. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
107A-02 is being developed by Viatris Inc. (NASDAQ: VTRS), a global healthcare company. The drug is currently in Phase 3 clinical trials for acute pain indications.
107A-02 is in Phase 3 clinical development for the treatment of acute pain. It has completed three clinical trials, including two Phase 3 studies, and remains an investigational drug that has not yet received regulatory approval.
107A-02 has completed three clinical trials: NCT05317312, a Phase 2 study in post-surgical dental pain with 111 participants; NCT06215820, a Phase 3 study in post-operative pain following bunionectomy with 410 participants; and NCT06215859, a Phase 3 study in post-operative pain following herniorrhaphy with 579 participants. All trials were conducted in the United States.
Yes, 107A-02 is also known as MR-107A-02. Clinical trial records refer to the drug as MR-107A-02, and it is being studied for the treatment of acute post-operative pain.