Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF614 solution, PF614 capsule, Oxycodone prodrug
PF614 · 4 trials · 3 indications
Pain at rest
The time to first pain was recorded by trained site staff using a stop watch. Each subject was instructed to remove their hand at 3 minutes if they had not yet reached pain tolerance. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.
The latency time to hand removal from the water bath was recorded by trained site staff using a separate stopwatch. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
| Arm | Type | Description |
|---|---|---|
| PF614 25 mg | EXPERIMENTAL | Oral administration every 12 hours |
| PF614 37.5 mg | EXPERIMENTAL | Oral administration every 12 hours |
| PF614 50 mg | EXPERIMENTAL | Oral administration every 12 hours |
| Placebo | PLACEBO_COMPARATOR | Oral administration every 12 hours |
| PF614 100 mg | EXPERIMENTAL | Oral 100 mg |
| PF614 200 mg | EXPERIMENTAL | PF614 200 mg capsule (2 x 100 mg capsules) |
| Oxycodone IR 40 mg | ACTIVE_COMPARATOR | Oxycodone HCl 40 mg (2 x 20 mg capsules over-encapsulated to match PF614 capsules). |
| PF614 100 mg capsule | EXPERIMENTAL | Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive PF614 100mg capsules in a randomized, double-blind, crossover manner. |
| Oxycodone HCl tablets | ACTIVE_COMPARATOR | Eligible subjects will be admitted to the clinical site on Day -1. Subjects will receive crushed oxycodone HCl IR 40mg in a randomized, double-blind, crossover manner. |
| Placebo powder in capsules | PLACEBO_COMPARATOR | Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive Placebo powder in a randomized, double-blind, crossover manner. |
| Name | Type | Description |
|---|---|---|
| PF614 capsule | DRUG | Experimental oxycodone prodrug |
| Placebo | DRUG | Inactive medication |
| PF614 | DRUG | Experimental oxycodone prodrug |
| Oxycodone Hydrochloride 40 mg | DRUG | Oral 20 mg tablets (two each) |
| Oxycodone | DRUG | Oxycodone HCl IR 40mg |
Inclusion Criteria: 1. Participant must provide written informed consent prior to the initiation of any protocol specific procedures. 2. Male or female participant, between 18 and 75 years of age, inclusive, at the time of Screening. 3. Participant must be scheduled to undergo a full abdominoplasty...
PF614 is being developed to treat acute pain, including acute postoperative pain. It is also being studied for its abuse potential in non-dependent recreational opioid users. EnSysce Biosciences is developing the drug as a small molecule therapeutic in the pain area.
PF614 is being developed by EnSysce Biosciences, Inc., which trades under the ticker ENSC. The company is the sponsor of the clinical program evaluating PF614 in acute pain and abuse potential studies.
PF614 is in Phase 2 development, with a Phase 3 trial also recruiting. The Phase 2 study NCT06629402 has been completed, and the Phase 3 study NCT06602271 is currently recruiting participants with acute postoperative pain. PF614 has received Breakthrough Therapy and Fast Track designations from the FDA.
PF614 has been evaluated in several trials. Completed studies include NCT06629402, a Phase 2 cold pressure test in acute pain, and two Phase 1 abuse potential studies, NCT05571345 and NCT05567354. A Phase 3 trial, NCT06602271, is currently recruiting patients with acute postoperative pain.
Yes, PF614 solution and PF614 capsule are alternative names for PF614. These refer to different formulations of the same investigational drug being developed by EnSysce Biosciences for acute pain and studied for abuse potential.
PF614 is investigational and has not been approved by the FDA. It is still in clinical development, with Phase 2 and Phase 3 trials ongoing or completed. The FDA has granted PF614 Breakthrough Therapy and Fast Track designations to support its development.