Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as INFS (Intranasal Fentanyl Spray)
INFS · 1 trial · 1 indication
AUC= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from simulated single dose concentration time profiles derived from the final parameters of the PopPK model \[clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)\].
| Arm | Type | Description |
|---|---|---|
| Sequence 1 (A-B-C) | EXPERIMENTAL | * A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1 * B: single dose of 400 μg INFS (100 μL), administered 4 hours after the first treatment * C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 24 hours after the first treatment (Day 2) |
| Sequence 2 (A-C-B) | EXPERIMENTAL | * A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1 * C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 4 hours after the first treatment * B: single dose of 400 μg INFS (100 μL), administered 24 hours after the first treatment (Day 2) |
| Name | Type | Description |
|---|---|---|
| INFS (Intranasal Fentanyl Spray) | DRUG | Intranasal Fentanyl Spray |
Eligibility Criteria: Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.
INFS is an intranasal fentanyl spray, a small molecule formulation of fentanyl delivered through the nose. It is being developed by Takeda Pharmaceutical Company Limited under the ticker TAK. The program has been studied in a Phase 1 pharmacokinetic trial in healthy volunteers, and the specific therapeutic indications have not been disclosed.
INFS is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the intranasal fentanyl spray program, including the Phase 1 pharmacokinetic study conducted in Germany.
INFS is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a pharmacokinetic trial of single doses of the intranasal fentanyl spray in healthy subjects, so INFS remains an investigational product rather than an approved medicine.
INFS has been evaluated in one completed Phase 1 trial, NCT01497288, titled a trial to investigate the pharmacokinetics of single doses of 200 µg, 400 µg and 2 x 400 µg of intranasal fentanyl spray in healthy subjects. The randomized, controlled study enrolled 20 participants in Germany.
Yes. INFS stands for intranasal fentanyl spray, so the abbreviation and the full name refer to the same Takeda product candidate. Searches for either term point to the same Phase 1 program studied in trial NCT01497288.
INFS is a small molecule formulation of fentanyl, an opioid, delivered as an intranasal spray. It is designed for absorption through the nasal mucosa. The completed Phase 1 trial assessed the pharmacokinetics of single 200 µg, 400 µg and 2 x 400 µg doses in healthy volunteers.