Ensysce Biosciences is a clinical-stage pharmaceutical company developing abuse-resistant and overdose-resistant opioid pain medications. Ensysce has no approved products or revenue and funds operations through NIH/NIDA grants and equity raises. The company's core thesis is that molecularly redesigning opioids — rather than adding crush-resistant polymer coatings — can eliminate abuse potential at the chemical level. Ensysce's lead candidate, PF614, is an oxycodone prodrug that remains chemically inert until activated by the digestive enzyme trypsin in the gut. Because trypsin is absent from the bloodstream and nasal passages, PF614 is designed to resist intravenous and intranasal abuse at the molecular level. PF614 entered a Phase 3 pivotal trial in 2025 evaluating efficacy in post-operative acute pain. Ensysce's second candidate, PF614-MPAR, combines PF614 with nafamostat, a trypsin inhibitor. At prescribed doses, the nafamostat has no effect, but excess capsules trigger the inhibitor to block oxycodone release, limiting overdose risk. PF614-MPAR received FDA Breakthrough Therapy designation in early 2024 and is currently in Phase 1b trials. If approved, Ensysce would sell branded prescription opioids through standard pharmaceutical distribution, priced at a premium to generic oxycodone — a model similar to existing abuse-deterrent brands like OxyContin and XTampza ER. Ensysce uses the FDA's 505(b)(2) regulatory pathway, which allows the company to rely on existing oxycodone safety data to reduce the clinical burden required for approval.