PF614 for Postoperative Pain

Recruiting at 1 trial location

Overseen By William K Schmidt, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ensysce Biosciences

Must not be taking: Opioids, NSAIDs, Steroids, Antidepressants

Disqualifiers: Cardiac disorders, Respiratory depression, Seizure disorder, Substance use disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 5 days

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PF614, a new extended-release pain medication, to evaluate its effectiveness in managing pain after abdominoplasty (commonly known as a tummy tuck). Researchers aim to determine if PF614 better relieves moderate to severe post-surgery pain compared to a placebo. Participants will take the medication before and after surgery and will report on their pain levels, any side effects, and need for additional pain relief. Those scheduled for a full abdominoplasty without liposuction and with no other significant health issues may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new pain management option.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PF614, a new type of oxycodone, releases slowly in the body to help prevent misuse. It is currently being tested for pain relief after surgery. Participants generally tolerate PF614 well. Common side effects include nausea, dizziness, and constipation, typical for opioid medications. Serious side effects are rare. As the study progresses into its later stages, confidence in its safety has increased. Prospective participants should discuss possible risks and benefits with the study team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about PF614 for postoperative pain because it offers a novel approach by using a prodrug mechanism. Unlike standard opioids that are often used for pain relief, PF614 is designed to be converted into its active form only in the presence of specific enzymes in the body, potentially reducing the risk of abuse and side effects. This targeted activation could mean effective pain relief with a lower risk of addiction, a significant improvement over traditional opioid treatments.

What evidence suggests that PF614 might be an effective treatment for postoperative pain?

Research has shown that PF614, an oral medication related to oxycodone, effectively relieves post-surgical pain. In earlier studies, PF614 released oxycodone, a strong pain reliever, in a controlled manner to manage moderate to severe pain. Participants in this trial will receive various dosages of PF614 or a placebo. Patients who took PF614 reported significantly less pain compared to those who took a placebo. The study also suggested that PF614 might facilitate the transition to non-opioid pain treatments after surgery, which is a major benefit. Overall, PF614 appears promising for managing post-surgical pain effectively. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults scheduled for abdominoplasty without liposuction, with a BMI of 18.0-32.0 kg/m2 and in good health as per American Society of Anesthesiologists (I-II). Participants must understand English or Spanish, agree to use contraception if necessary, and be able to complete all study requirements.

Inclusion Criteria

I am in good health or have mild systemic disease according to a surgery readiness scale.

I have given my written consent for the trial procedures.

I agree to use or have my partner use birth control during and after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive oral blinded doses of study medication starting 1 hour before surgery and every 12 hours for up to 4 days

5 days

Inpatient stay for 5 days

Outpatient

Participants record pain and adverse effects in a diary for 2-4 days after discharge

2-4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

7-9 days

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• PF614

Trial Overview

The trial tests PF614's effectiveness in managing post-surgery pain compared to a placebo. Patients will take the medication before surgery and every 12 hours after for up to four days while their pain levels are monitored.

How Is the Trial Designed?

Group I: PF614 50 mg Experimental Treatment 1 Intervention

Oral administration every 12 hours

Group II: PF614 37.5 mg Experimental Treatment 1 Intervention

Oral administration every 12 hours

Group III: PF614 25 mg Experimental Treatment 1 Intervention

Oral administration every 12 hours

Group IV: Placebo Placebo Group 1 Intervention

Oral administration every 12 hours

Who Is Running the Clinical Trial?

Ensysce Biosciences

Lead Sponsor

Trials

9

Recruited

700+

Rho, Inc.

Industry Sponsor

Trials

25

Recruited

5,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06602271

PF614 Analgesic Activity in Acute Postoperative Pain ...

To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants ...

2.

ir.ensysce.com

ir.ensysce.com/news/press-releases/detail/195/ensysce-biosciences-initiates-pivotal-phase-3-study-of

Ensysce Biosciences Initiates Pivotal Phase 3 Study of ...

The study aims to confirm that PF614 delivers powerful pain relief and facilitates the transition to non-opioid out-patient care. To execute ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06602271/pf614-analgesic-activity-in-acute-postoperative-pain-pf614-301

PF614 Analgesic Activity in Acute Postoperative Pain ...

This will be a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled study to evaluate the efficacy and safety of PF614 ...

4.

trialstoday.org

trialstoday.org/trial/NCT06602271

PF614 Analgesic Activity in Acute Postoperative Pain ...

The main question to be answered is: • To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following ...

5.

firstwordpharma.com

firstwordpharma.com/story/5737680

Ensysce Biosciences Announces Successful Completion of ...

In our PF614-MPAR-101 study, the data showed that a 25 mg dose of PF614-MPAR, delivered oxycodone as designed for what may be a prescribed ...

6.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0144016

Postoperative Pain, Acute (DBCOND0144016)

Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy ... PF614 Analgesic Activity in Acute ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6790176/

Nonclinical Safety Assessment of PF614: a Novel TAAP ...

PF614, a novel trypsin activated abuse protection (TAAP) prodrug of oxycodone, is being studied as chronic pain analgesic with extended release and abuse ...

8.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT06602271/

Trial | NCT06602271

This will be a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled study to evaluate the efficacy and safety of PF614 in the ...