This section highlights FDA-related milestones and regulatory updates for drugs developed by Ensysce Biosciences (ENSC).
Over the past two years, Ensysce Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PF614-301, PF614-MPAR, and PF614-MPAR-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PF614-301 - FDA Regulatory Timeline and Events
PF614-301 is a drug developed by Ensysce Biosciences for the following indication: For the Treatment of Moderate to Severe Pain after Abdominoplasty".
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614-301
- Announced Date:
- September 19, 2024
- Indication:
- For the Treatment of Moderate to Severe Pain after Abdominoplasty"
Announcement
Ensysce Biosciences, Inc. announced it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA.
AI Summary
Ensysce Biosciences has submitted its PF614-301 protocol to the FDA as part of a Phase 3 study. The study is designed as a multicenter, randomized, double-blind, placebo- and active-controlled trial to test the efficacy and safety of PF614 for treating moderate to severe pain after abdominoplasty. Included in this submission is the company’s statistical analysis plan, which the FDA will review and provide input on. The trial will be conducted at four to six clinical sites across the United States. It aims to assess PF614’s effectiveness against both a placebo and an active comparator, while also evaluating the need for rescue medication and monitoring safety. This FDA submission is a significant step forward in the clinical development of PF614, as the company works towards finalizing the study and gathering the necessary data to advance the treatment into the final phase of evaluation.
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PF614-MPAR - FDA Regulatory Timeline and Events
PF614-MPAR is a drug developed by Ensysce Biosciences for the following indication: Opioid overdose.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614-MPAR
- Announced Date:
- April 15, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences announced the completion of Part 1 of its second clinical trial for PF614-MPAR, a formulation designed to treat severe pain while reducing the risk of overdose. In this study, subjects received multiple 100 mg doses of PF614-MPAR, which combines the Company’s TAAP™ and MPAR® technologies. The results showed that when more than the prescribed dosage was taken, the maximum release of oxycodone (Cmax) was lower than with the unprotected version, indicating successful overdose protection. Importantly, the trial reported no unexpected adverse events, supporting both the safety and the overdose protection profile of PF614-MPAR. These promising findings will be shared with the FDA in upcoming meetings as Ensysce moves forward with further parts of the trial. The company is optimistic that these results will help advance PF614-MPAR toward eventual commercialization as a safer opioid treatment option.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- February 5, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, announced continued subject enrollment and successful dosing augmenting the progress of its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences has reported significant progress with its second clinical trial evaluating PF614-MPAR for overdose protection. The company announced continued enrollment of subjects and successful dosing, which marks an important step in the trial’s progress. The study, known as PF614-MPAR-102, is evaluating a 100 mg dosage form of the drug to confirm its ability to protect against overdose even when larger doses are taken. Researchers have now enrolled subjects in the highest dosing cohort, equivalent to five times the 100 mg dose unit, and have observed only limited adverse events. This positive progress supports PF614-MPAR’s safety profile and highlights the drug’s potential as a novel opioid treatment. The recent results contribute to the overall momentum in developing safer pain management treatments with built-in overdose protection.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- January 22, 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, announced interim data from its second clinical trial to evaluate PF614-MPAR for overdose protection.
AI Summary
Ensysce Biosciences has shared promising interim results from its second clinical trial evaluating PF614-MPAR for overdose protection. The study, PF614-MPAR-102, explored the full dosage range of the formulation, including a 100 mg dose that was designed to reduce the blood concentration of oxycodone when an excessive dose is taken. In the trial, subjects served as their own controls and showed significantly lower maximum blood levels of oxycodone (Cmax) with PF614-MPAR compared to the standard PF614 formulation, highlighting its protective benefits. The study also compared single dosing, where no significant differences were observed, with multiple dosing that demonstrated clear overdose protection. Future phases of the trial will look at potential food effects and the impact of repeat dosing. These encouraging findings support ongoing efforts to develop safer opioid treatments with built-in overdose protection.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- November 26, 2024
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced that it has treated its first group of subjects in the PF614-MPAR-102 study.
AI Summary
Ensysce Biosciences, Inc. announced that it has begun treating the first group of subjects in its PF614-MPAR-102 study. The trial is aimed at evaluating the safety and effectiveness of PF614-MPAR, a next-generation opioid designed to help reduce the risk of both accidental and intentional overdoses. The study will test PF614-MPAR in various dose ranges and under different conditions, including food effects and multi-ascending doses, to gather a broad set of data. Early interim results are expected in the first quarter of 2025, which could provide key insights into the drug's overdose protection features. Ensysce is partnering with Quotient Sciences and using their Translational Pharmaceutics® platform to support this work, as part of their continued effort to develop safer pain relief alternatives.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- November 26, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences Expects Early Interim Data in 1Q 2025
AI Summary
Ensysce Biosciences, a company working on safer pain relief options, has started its PF614-MPAR-102 study. The study is designed to assess the pharmacokinetics and safety of PF614-MPAR, an opioid developed to lower the risk of abuse and overdose. The company aims to complete this three-part trial with the goal of collecting early interim data in the first quarter of 2025. This data will be important for advancing discussions with the FDA about registering the product as an overdose-protected opioid. The drug has received Breakthrough Therapy designation from the FDA, highlighting its potential in addressing the risks tied to prescription opioids. Ensysce is using advanced technology platforms and collaborations to achieve a safer treatment option for severe pain, supporting its focus on reducing accidental and deliberate overdoses.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- August 27, 2024
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.'
AI Summary
Ensysce Biosciences has received Investigational Review Board (IRB) approval for its PF614-MPAR-102 study protocol. The study is designed as a single and multiple dose trial to evaluate the pharmacokinetics of oxycodone and PF614 when administered together with nafamostat. The trial will explore how the two drugs work when delivered as an immediate release solution alongside an extended-release capsule formulation in healthy subjects.
This IRB approval marks a significant step forward in Ensysce’s development program, which aims to create safer opioids that reduce the risk of abuse and overdose. The study is part of a broader initiative using Ensysce’s innovative platforms and involves collaboration with Quotient Sciences, utilizing their Translational Pharmaceutics® platform to streamline clinical research. The results of this research are expected to further guide the development of effective and safer treatments for severe pain management.
Read Announcement- Drug:
- PF614-MPAR
- Announced Date:
- May 20, 2024
- Indication:
- Opioid overdose
Announcement
Ensysce Biosciences, Inc. announced the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product.
AI Summary
Ensysce Biosciences, Inc. has renewed its collaboration with Quotient Sciences to carry out study PF614-MPAR-102, which will examine the full commercial dose range of its breakthrough opioid drug, PF614-MPAR. The study will test three different doses—25 mg, 50 mg, and 100 mg—administered twice daily for five days to assess both the protection against overdose and the effective delivery of oxycodone. PF614-MPAR is a unique abuse-resistant opioid product that stops drug release when too many pills are taken, providing a safeguard against both accidental and deliberate overdose. Quotient Sciences will use its Translational Pharmaceutics® platform in the study to manufacture and test the drug product, helping to optimize the formulation and speed up the clinical evaluation process.
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PF614-MPAR-102 - FDA Regulatory Timeline and Events
PF614-MPAR-102 is a drug developed by Ensysce Biosciences for the following indication: To study the effect of food on the MPAR technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PF614-MPAR-102
- Announced Date:
- June 24, 2025
- Indication:
- To study the effect of food on the MPAR technology.
Announcement
Ensysce Biosciences, Inc. announced it has fully enrolled Part 2 of the critical three-part PF614-MPAR-102 clinical study to study the effect of food on the MPAR technology.
AI Summary
Ensysce Biosciences announced that it has fully enrolled Part 2 of its three-part PF614-MPAR-102 clinical study, which is designed to evaluate the effect of food on its MPAR technology. This study is a key step in determining how food impacts the performance and safety of its novel opioid formulation. PF614-MPAR leverages proprietary TAAP and MPAR technologies to maintain effective pain relief while including built-in overdose protection if doses exceed the prescribed amount. The clinical study is an important milestone in the company’s efforts to develop safer opioid medications, especially in the context of reducing opioid abuse and overdose risks. This phase of research contributes to Ensysce’s overall mission to introduce innovative, tamper-proof treatments for severe pain, potentially redefining treatment protocols and improving patient safety.
Read Announcement
