Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FX301 · 1 trial · 2 indications
Incidence of treatment emergent adverse events after a single analgesic nerve block of FX301
| Arm | Type | Description |
|---|---|---|
| FX301 Low Dose Low Volume | EXPERIMENTAL | 65 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 Low Dose High Volume | EXPERIMENTAL | 130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 High Dose Low Volume | EXPERIMENTAL | 130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 High Dose High Volume | EXPERIMENTAL | 260 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| Normal Saline | PLACEBO_COMPARATOR | Low or high matching volume of preservative-free normal saline given as a single injection adjacent to the sciatic nerve of the popliteal fossa |
| Name | Type | Description |
|---|---|---|
| FX301 | DRUG | FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain |
| Normal Saline | DRUG | Single peripheral nerve injection |
Inclusion Criteria: 1. Written consent to participate in the study 2. Be willing and able to complete study procedures and pain scales, follow instructions and communicate meaningfully in English with study personnel, and return for outpatient follow-up visits as required. 3. Male or female ≥18 to ...
FX301 is an investigational small molecule being developed for postoperative pain, specifically studied in patients undergoing bunionectomy. It is intended to manage pain following surgical procedures. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
FX301 is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PCRX. The company is conducting clinical trials to evaluate the safety and tolerability of FX301 in patients experiencing postoperative pain.
FX301 is in Phase 1 clinical development. A Phase 1 trial has been completed, evaluating the safety and tolerability of the drug in patients undergoing bunionectomy. As an investigational drug, FX301 has not yet received FDA approval and remains in early-stage clinical testing.
FX301 has one completed clinical trial registered as NCT04826328, titled 'Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy.' This Phase 1, randomized, double-blind, placebo-controlled trial enrolled 85 participants in the United States and has been completed.
FX301 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed safety and tolerability, but the drug has not yet progressed through the later stages of clinical testing required for regulatory approval.