Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PMI-150 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter. |
| 2 | PLACEBO_COMPARATOR | Placebo at time 0 and specified time points thereafter. |
| Name | Type | Description |
|---|---|---|
| PMI-150 (intranasal ketamine) | DRUG | PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter. |
| Placebo | DRUG | Placebo (intranasal) at time 0 and scheduled times thereafter. |
Inclusion Criteria: * patient is scheduled for elective orthopedic surgery or procedure Exclusion Criteria: * patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
PMI-150 is an investigational small molecule being developed for the treatment of postoperative pain. It is a Phase 3 intranasal ketamine formulation studied in patients following orthopedic surgery. The drug is not yet approved and remains in clinical development.
PMI-150 is a formulation of ketamine, which acts as an NMDA receptor antagonist. By blocking the NMDA receptor, it modulates pain signaling in the central nervous system. This mechanism underlies its potential use in managing acute postoperative pain.
PMI-150 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy for postoperative pain.
PMI-150 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not received FDA approval.
PMI-150 has one completed Phase 3 trial, NCT00709436, which evaluated the safety and efficacy of repeated doses of intranasal ketamine in acute postoperative pain following orthopedic surgery. The trial enrolled 250 participants in the United States.
PMI-150 is an intranasal formulation of ketamine, a well-known anesthetic and analgesic agent. While ketamine itself is approved for other uses, PMI-150 is a specific investigational product being developed by Pfizer for postoperative pain and is not yet approved.