Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single dose of SUF NT · 1 trial · 1 indication
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p \>0.05)
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
| Arm | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg | EXPERIMENTAL | Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
| Name | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg | DRUG | - |
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | DRUG | - |
Inclusion Criteria: * Non smoking * Ages 18 to 45 year, inclusive * BMI between 18 and 30 Exclusion Criteria: * Subjects taking any prescription or OTC medications or vitamins or supplements * Pregnant females * Subjects with pulmonary disease or sleep apnea
Single dose of SUF NT is an investigational small molecule therapeutic candidate developed by Talphera, Inc. It is being studied in a Phase 1 clinical program, and its intended clinical indications have not been disclosed. The asset has been evaluated in one completed Phase 1 trial involving 40 healthy adult volunteers.
Single dose of SUF NT is being developed by Talphera, Inc., which trades under the ticker TLPH. The company is the sponsor of the clinical program for this investigational asset, including the completed Phase 1 pharmacokinetic study conducted in the United States.
Single dose of SUF NT is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. It is an investigational candidate and has not been approved by the FDA for any indication.
Single dose of SUF NT has been studied in one completed Phase 1 trial, NCT01761565, titled Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab. The trial enrolled 40 healthy adult volunteers aged 18 years and older in the United States and measured plasma concentrations.
The Phase 1 trial NCT01761565 was an uncontrolled study of Single dose of SUF NT in 40 healthy adult volunteers aged 18 years and older. It was not randomized and not double blinded, and it evaluated plasma concentrations in participants in the United States. The trial is completed.