Ensysce Biosciences - $ENSC - PF614-MPAR - Novel Opioid Designed to Prevent Abuse and Overdose

Starting thread for news posts and discussion around ENSC

Ensysce Biosciences has no FDAA approved drugs, but is developing:

PF614-MPAR - novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose.

Considering the opioid epidemic in US it should have big support and market potential in case of FDAA approval.

That being said, with current market cap of 15m and one drug lotto in play, it is hit or miss.

Phase 1 is completed, data release should be Q1 2023

Their ER is on 30.3.2023, that could be catalyst or just potential date if you want to capture the runup in expectations of catalyst.

They recently finished diluting by 3m in need of funds for further development at 0.84$, so stock is pretty beat down.

Their CEO bought 500k worth of shares at 1.5$ shortly before that, so he should be motivated to get to stock above that price.

They are currently sub-dollar stock, but received grace period for nasdaq listing until 12th June 2023

Trial status:


Company website:

Link to Company Presentation: https://d1io3yog0oux5.cloudfront.net/_6aabf59d5b56833973d24ae8fefea2a2/ensysce/db/1988/18613/pdf/ENSC-Presentation.pdf

Link to Shareholder Letter: https://www.bloomberg.com/press-releases/2023-01-11/ensysce-biosciences-issues-2023-shareholder-letter (edited)


Thank you @SADA, after a lot of reading couple of thoughts from me:

Basically, the vision of the company is to develop the next generation of opioids to treat severe pain while limiting the potential for abuse or overdose. Why is this a problem? Substance Abuse is the Nation’s #1 Health Problem and leads to 107,000 Overdose Deaths in 2021. At the same time severe pain is concomitant of a lot of diseases, such as Cancer.

Their leading research program is PF614 with the following goals:

  • Longer Pain Relief
  • True 12-hour Half-Life Ease of Swallowing
  • Can Dissolve in Water2 Can Be Taken with or without Food
  • Difficult to Manipulate Blocks Opioid Release if Inhaled/ Injected
  • Overdose Protection can be Added – Unique to Industry

To add the protection the company developed two core technology platforms

  • TAAP (trypsin activated abuse protection): designed to protect against prescription drug abuse

  • MPAR ( multi-pill abuse resistance): designed to protect against abuse and accidental overdose

What do we know so far:
PF614 for severe pain combined with the ‘TAAP’ protection platform delivers potent pain relief equivalent to Oxycontin (Standard of Care) with reduced abuse potential

  • PF614 chemically releases oxycodone with the same extended release (ER) profile as OxyContin
  • The same release profile demonstrates that PF614 will achieve similar pain relief as OxyContin.
  • PF614, even when crushed, releases oxycodone slowly in the blood, thereby reducing the large Cmax which leads to reduced ‘drug liking’.
  • The study demonstrated the significant difference between the manipulated PF614 versus manipulated (crushed) OxyContin

As a result the FDA granted fast track for for severe pain + ‘TAAP’ oxycodone.

Regarding PF614 -MPAR TAAP (so protection by both platforms) pre-clinical data demonstrates that MPAR blocks Activation of PF614 and Oxycodone Release if Overdosed. I believe this is highly impressive. The only caveat is that its pre-clinical data.

The upcoming data catalyst is the read out of the Phase 1 PF614-104 Study. This study is designed to test and confirm that PF614 will have less potential for drug liking versus immediate release oxycodone at equivalent drug dosages. It does not include any protection platform (TAAP, MPAR).

The Goal of the Study is to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone
If the data confirms what the company already promises we could see small jump, but for me the binary catalyst comes later in the year: PF614-MPAR-101 - (MPAR): Overdose Protection. This Trial is focused to proof the pre-clinical data under a clinical setting.

Position: Recommend a small position that you are willing to risk and hold throughout 2023 as the upcoming catalyst is not the binary catalyst and given the risk of delisting



The update is addressing the key questions in terms of pipline and outlook.

Most Important:

We have reported positive results on three of these studies, and we are currently awaiting data from our oral abuse potential study, PF614-104, at the end of March.


We see some green pre-market on this news but given the recent reverse split and the uncertainty regarding their financials i wouldn’t be surprised if we end up having a red day. I will exit the play during this week.

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