Ensysce Biosciences Advances Abuse-Resistant Opioids PF614 and PF614-MPAR Towards Market
• Ensysce Biosciences reports significant progress in its clinical programs for PF614 and PF614-MPAR, designed for safer pain relief with reduced abuse potential.
• PF614, an extended-release oxycodone, is set to begin Phase 3 trials in Q2 2025, evaluating its efficacy in post-abdominoplasty pain management.
• PF614-MPAR received FDA Breakthrough Therapy designation and is undergoing Phase 1b trials to verify overdose protection and effective oxycodone delivery.
• Ensysce's Opioid Use Disorder (OUD) program advances with PF9001 as the lead candidate, showing promise for safer treatment with fewer cardiovascular side effects.
Ensysce Biosciences' PF614-MPAR Demonstrates Overdose Protection in Clinical Trial
• Ensysce Biosciences' PF614-MPAR shows overdose protection in a Phase 1b clinical trial, reducing oxycodone blood concentration.
• The study, PF614-MPAR-102, evaluated the pharmacokinetics of PF614-MPAR across a range of doses in healthy subjects.
• PF614-MPAR has received Breakthrough Therapy designation from the FDA, supported by a $14 million NIDA grant.
• The company is advancing towards commercialization, with plans to discuss registration with the FDA.
Psychedelic Therapy Faces Regulatory Hurdles Despite Promising Research
• The FDA's rejection of Lykos Therapeutics' MDMA therapy for PTSD highlights challenges in psychedelic research, emphasizing the need for consistent and predictable clinical trial outcomes.
• Regulatory focus on drug components over therapy combinations necessitates innovative approaches for integrating psychotherapy with psychedelic treatments, potentially involving collaborations between the FDA and professional organizations.
• NIDA's funding of ketamine studies signals growing acceptance of psychedelics' therapeutic potential, driving further research into their efficacy for conditions like depression and PTSD.
• Key research areas include determining the durability of treatment effects and understanding how psychedelics impact diverse populations, requiring meticulous trial designs and robust data collection.
GLP-1 Agonists Show Promise in Addiction Treatment: Beyond Weight Loss
• GLP-1 agonists, initially for diabetes and obesity, are being explored for their potential in treating substance use disorders by targeting brain mechanisms.
• Studies suggest GLP-1 agonists may reduce cravings for addictive substances by impacting the brain's reward system, showing potential in reducing binge drinking and opioid overdoses.
• Clinical trials are underway to investigate the efficacy of GLP-1 agonists like semaglutide in treating various substance use disorders, with results expected in the coming years.
• Experts emphasize that while promising, GLP-1 medications should be part of a comprehensive treatment plan, including community support and therapy, for individuals with addiction.
Ananda Scientific Initiates Clinical Trial of Nantheiaâ„¢ ATL5 for Opioid Use Disorder and Chronic Pain
• Ananda Scientific has begun a clinical trial at Yale School of Medicine to assess Nantheia™ ATL5, a CBD-based investigational drug, for treating co-occurring opioid use disorder (OUD) and chronic pain.
• The randomized, double-blind, placebo-controlled study will evaluate Nantheia™ ATL5, co-administered with THC, to relieve pain and cue-induced craving in OUD patients maintained on methadone.
• The trial's primary goal is to determine the therapeutic potential of Nantheia™ ATL5 with THC, while a secondary objective is to assess if THC independently alters the effect of Nantheia™ ATL5 (CBD) alone.
• Nantheia™ ATL5 utilizes Ananda's Liquid Structure™ delivery technology to enhance the effectiveness, absorption, and stability of cannabidiol.
Cebranopadol Shows Promise in Phase 3 Trial for Acute Pain Management
• Tris Pharma's cebranopadol significantly reduced pain intensity in patients following abdominoplasty in the ALLEVIATE-1 Phase 3 trial.
• The investigational dual-NMR agonist demonstrated a favorable safety profile, comparable to placebo, with nausea being the most common adverse event.
• Cebranopadol targets both nociceptin/orphanin FQ peptide (NOP) and μ-opioid peptide (MOP) receptors, offering a novel approach to pain relief.
• Tris Pharma plans to submit a New Drug Application (NDA) for cebranopadol later this year, with further studies in chronic pain indications planned.
Lofexidine Trial Launched for Neonatal Opioid Withdrawal Syndrome
• Marshall University is conducting a clinical trial to assess oral lofexidine, a non-opioid medication, for treating Neonatal Opioid Withdrawal Syndrome (NOWS).
• The Phase 2 trial aims to evaluate the safety and pharmacokinetics of lofexidine in newborns exposed to opioids prenatally.
• Unlike opioid-based treatments, lofexidine does not produce euphoria or addiction potential, offering a potentially safer alternative.
• The study will monitor NOWS symptoms using the Modified Finnegan Neonatal Abstinence Scoring Tool (mFNAST) and assess treatment duration.
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