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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 developed by Viatris Inc. (ticker VTRS) for the treatment of pain. It has been studied in a Phase 2 clinical trial in post-surgical dental pain. It is not an approved product and remains in clinical development.
107A-01 is being developed for pain, including acute and post-surgical pain. Its completed Phase 2 trial enrolled adults with post-surgical dental pain. The program is investigational, so 107A-01 is not approved for any use and is not available as a treatment.
Viatris Inc., which trades under the ticker VTRS, is the developer of 107A-01. The company is listed as the sponsor of the drug's clinical program, including the completed Phase 2 study in post-surgical dental pain conducted in the United States.
107A-01 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. Because the program is still in clinical development, 107A-01 is investigational and has not been approved by the FDA for any indication.
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 study enrolled 114 participants aged 18 and older in the United States.
Yes. 107A-01 and MR-107A-01 refer to the same investigational drug from Viatris Inc. The Phase 2 trial in post-surgical dental pain is registered under the name MR-107A-01, while the shorter form 107A-01 is also used for the same asset.