Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PMI-150 (intranasal ketamine)
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 being developed for the treatment of acute postoperative pain, specifically pain following orthopedic surgery. It is an intranasal formulation studied in adults aged 18 years and older. The program is in Phase 3 development and is not yet approved.
PMI-150 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the intranasal formulation in acute postoperative pain.
PMI-150 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program has not been approved by the FDA and remains investigational.
PMI-150 has been studied in one Phase 3 trial, NCT00709436, titled Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery. The trial enrolled 250 participants in the United States and is completed.
Yes. PMI-150 is also known as PMI-150 (intranasal ketamine). It is a small molecule formulation of ketamine delivered intranasally, developed for acute postoperative pain.
The Phase 3 trial NCT00709436 was a randomized, double-blind, placebo-controlled study of repeated doses of PMI-150 in acute postoperative pain following orthopedic surgery. It enrolled 250 adults aged 18 years and older, including both sexes, and did not use healthy volunteers.