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Also known as MR-107A-02
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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
107A-02 is being developed for the treatment of acute pain, including acute postoperative pain. Its clinical trials have studied pain following herniorrhaphy, bunionectomy, and dental surgery. It is an investigational small molecule and has not been approved for any use.
107A-02 is being developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical program evaluating the drug in acute pain, including the completed Phase 3 studies in postoperative pain following herniorrhaphy and bunionectomy.
107A-02 is in Phase 3 development. Two Phase 3 trials have been completed: one in acute postoperative pain following herniorrhaphy and one following bunionectomy. An earlier Phase 2 trial in post surgical dental pain was also completed. No trials are currently active.
Three completed trials have evaluated 107A-02. NCT06215859 was a Phase 3 study in acute postoperative pain following herniorrhaphy with 579 participants. NCT06215820 was a Phase 3 study in pain following bunionectomy with 410 participants. NCT05317312 was a Phase 2 study in post surgical dental pain with 111 participants.
Yes, 107A-02 and MR-107A-02 refer to the same investigational drug. MR-107A-02 is the alternative name used for this small molecule, which Viatris Inc. is developing for acute pain. Searches for either name point to the same clinical development program.
No, 107A-02 is not approved. It is an investigational small molecule still in clinical development, with Phase 3 trials completed in acute postoperative pain. The program includes three completed randomized, double-blind, placebo-controlled studies enrolling about 1,100 participants in total.