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Also known as MR-107A-01
107A-01 · 1 trial · 3 indications
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 17 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-01 15 mg once in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 10 mg once in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 15 mg twice in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 10 mg twice in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| Placebo twice in a 24-hour period | PLACEBO_COMPARATOR | Placebo tablet one day of dosing |
| Name | Type | Description |
|---|---|---|
| MR-107A-01 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
Inclusion Criteria: 1. Males and females ≥18 years of age. 2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction. 3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours followi...
107A-01 is an investigational small molecule being studied for the treatment of pain. Its clinical development has focused on acute post-surgical dental pain, a common model for evaluating analgesic candidates. It is not approved for any indication and remains in clinical development.
107A-01 is being developed by Viatris Inc., which trades on Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program evaluating the compound in pain.
107A-01 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The compound has not been approved by the FDA or any other regulatory agency and remains investigational.
107A-01 has been evaluated in one completed Phase 2 trial, NCT04571515, titled a dose-response study of MR-107A-01 in the treatment of post-surgical dental pain. The randomized, double-blind, placebo-controlled trial enrolled 114 participants in the United States.
Yes. 107A-01 and MR-107A-01 refer to the same investigational compound. MR-107A-01 is the alternative name used in the clinical trial registry entry for the Phase 2 post-surgical dental pain study sponsored by Viatris.