OOR x μ opioid receptor

MONMOUTH JUNCTION, N.J.--( BUSINESS WIRE )--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced that the company will present data from its first-in-class, late-stage investigational pain therapy with a novel mechanism of action, cebranopadol, at the upcoming International Association for the Study of Pain (IASP) 2024 World Congress on Pain, taking place August 5-9, 2024, in Amsterdam. “I am inspired to see the rise in interest, funding and research into the development of novel treatment options for the millions of people who suffer daily from debilitating pain that impacts their quality of life,” said Ketan Mehta, founder and CEO at Tris Pharma. “Our team has been working with urgency to advance cebranopadol, a first-in-class investigational pain therapy with a novel mechanism of action, through clinical studies with the goal of offering physicians an effective treatment option that they can confidently prescribe and patients feel is safe. We look forward to collaborating with the pain community at IASP 2024 and sharing our latest findings.” Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist in development to treat moderate-to-severe pain. Dual-NMR agonist compounds have the potential to deliver gold-standard pain relief with a strong safety profile because they mimic the body’s natural pain-modulation processes by synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor. Tris Pharma plans to share important news regarding its Phase 3 clinical trials in the near future. Symposium Highlighting Novel Pain Mechanism Tris Pharma will host a symposium featuring a series of presentations focused on dual-NMR agonists, a promising new mechanism of action in treating pain, and its potential to overcome the shortfalls of opioids for moderate-to-severe pain. The symposium will be presented as part of the congress by leading scientists with extensive experience in the research and development of novel pain therapies. Details of the symposium are as follows: Symposium: Break the Mold in Pain Biology: The Promise of a New Mechanism that May Overcome the Shortfalls of Current Moderate to Severe Pain Medications Presenters: Charles E. Argoff, MD, Albany Medical College; Roberto Ciccocioppo, PhD, University of Camerino; Jeffrey Gudin, MD, University of Miami Miller School of Medicine Location: RAI Amsterdam Convention Centre, Elicium I Date and Time: August 6, 12:45 – 1:45 p.m. CEST At IASP 2024 Tris Pharma will be present at Booth #316 where company executives will be available to provide additional information and data presented at the congress. About Cebranopadol (TRN-228) Cebranopadol is the first and only investigational dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a first of its kind and novel mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of misuse while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. The FDA has granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management studies, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with significantly less risk for misuse or risk of physical dependence, addiction or overdose. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @ TrisPharma .

Studies Conducted at University of Oklahoma Health Sciences Center and Florida Atlantic University Under Grant from U.S. Department of Defense Showed Drug Reduced Stress and Alcohol Consumption in in Vivo Studies WOODS CROSS, Utah--(BUSINESS WIRE)--Phoenix PharmaLabs, Inc. ( ), a private company developing potent, non-addictive treatments for pain and substance abuse disorders, today announced that in vivo studies demonstrated that the company’s lead compound, PPL-138, reduced symptoms of PTSD and decreased alcohol consumption in a rat model of PTSD/AUD (alcohol abuse disorder). The work conducted at University of Oklahoma Health Sciences Center and Florida Atlantic University under a grant from the US Department of Defense (DoD), funded through the Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (PASA)*, demonstrates that PPL-138 may have potential to be an effective treatment for these common comorbid disorders. Dr. Andrea Cippitelli in the Department of Biomedical Science, Charles E. Schmidt College of Medicine, is the principal investigator of the grant. Dr. Cippitelli has been examining the ability of the drug to reduce alcohol consumption in anxiety-susceptible or anxiety-resistant PTSD subjects. “When modeling PTSD in animals, it is important to take into consideration that trauma induces PTSD in only a portion of individuals and anxiety can be a trigger for increased alcohol consumption,” noted Dr. Cippitelli. Dr. Kelly Standifer, Professor and Chair of the Department of Pharmaceutical Sciences, College of Pharmacy and Richard T. Anderson Chair in Neuroscience is the principal investigator for the OUHSC arm of the study that exams the ability of this novel compound to alleviate pain and anxiety-like symptoms associated with PTSD over time. “We chose this model of PTSD because it produces a wide range of comorbidities experienced by those diagnosed with PTSD. It’s exciting that something non-addictive appears to reduce pain, anxiety-like behaviors and alcohol consumption so effectively,” Dr. Standifer said. A patent application for the Use of PPL-138 for treatment of PTSD/AUD has just been This new indication for PPL-138 is in addition to patents already granted or currently filed for the compound’s use in treatment of acute/chronic pain and substance abuse disorders. Dr. Lawrence Toll, Professor, Biomedical Science at Schmidt College of Medicine at Florida Atlantic University and FAU Stiles-Nicholson Brain Institute Investigator, who also serves as Phoenix’s Chief Neuropharmacologist, coordinated the studies and serves as a co-investigator for the project. “We continue to be impressed with the ability of PPL-138 to provide potential therapeutic benefits in the areas of pain, substance abuse, as well as this new indication for PTSD,” Dr. Toll said. “We are moving forward in our development of PPL-138 for safe, potent, non-addictive treatment for moderate to severe acute and chronic pain,” said William Crossman, president and CEO of Phoenix PharmaLabs. “The additional research and development of PPL-138 for other indications provides the company with new avenues for potential licensing and revenue streams. More immediately, it enables us to utilize grants that can further develop the compound for these additional indications.” Crossman added that the company is in the midst of its final pre-clinical studies to enable it to seek IND approval from the FDA to initiate human clinical trials. Phoenix has been the recipient of more than $12 million in grants from governmental entities such as NIDA and the US Army to develop treatments to address critical unmet needs: Safe, potent, non-addictive relief of moderate to severe pain Treatment for various types of addiction Treatment for PTSD/AUD Phoenix PharmaLabs is a preclinical drug discovery company. In addition to the company’s lead compound, PPL-138, Phoenix has a portfolio of 25 other compounds that have the potential to treat pain, substance abuse and addiction. The company has funded its efforts through grants as well as more than $6 million of private funding. The company currently has a $3 million convertible note offering of which $1 million has already been raised. *The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Alcohol and Substance Abuse Research Program under Award No. W81XWH-18-2-0044. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigator(s) adhered to the laws of the United States and regulations of the Department of Agriculture.

– Positive results confirm findings from prior studies evaluating the abuse potential of cebranopadol, further highlighting its potential as a safe and potent alternative to traditional opioids – – Registrational phase 3 clinical trials of cebranopadol in moderate to severe acute pain are on track to initiate in Q4 2023 – MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced new data from a human abuse potential (HAP) study of cebranopadol (TRN-228) which suggest the investigational compound has significantly lower abuse potential compared to both schedule II and schedule IV opioids. The findings will be shared on Thursday, September 7, in a poster presentation at the 2023 PAINWeek conference in Las Vegas. Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist (dual-NMR) analgesic in clinical development for the treatment of moderate to severe pain​, as well as opioid use disorder (OUD). Clinical studies to date suggest that the first-in-class dual-NMR analgesic has the potential to become the first pain-relief therapy to provide efficacy equivalent to traditional opioids with significantly less potential for abuse or risk of physical dependence, addiction or overdose. “Given that the opioid epidemic continues to have a devastating impact on a global scale and millions of people live each day with pain that is not well managed, the importance of developing novel safe and effective pain management therapies cannot be overstated,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “The data shared today validate our clinical efforts to advance cebranopadol and reinforce the potential of this investigational therapy to contribute to a future where pain can be managed without further exacerbating the impact of drug addiction.” HAP studies are required prior to U.S. Food and Drug Administration (FDA) approval in therapeutic classes with abuse potential. The cebranopadol oral HAP study was a randomized, double-blind, five-way crossover study of 45 participants, designed to evaluate the abuse potential of cebranopadol in adult nondependent recreational opioid users versus placebo; oxycodone, a schedule II narcotic; and tramadol, a schedule IV narcotic. Eligible participants underwent a naloxone challenge to confirm non-dependence to opioids and a qualification phase to assess that they could tolerate oxycodone and tramadol and discriminate their effects from placebo. Study participants randomly received a single dose of placebo, cebranopadol 600 μg, cebranopadol 1000 μg, tramadol IR 600 mg or oxycodone IR 40 mg. The primary endpoint was maximum drug liking “at this moment,” measured using a bipolar 100-point visual analog scale (VAS). Key secondary endpoints included “overall drug liking” and “take drug again” scores measured by the VAS. Overall, study findings suggest that cebranopadol has significantly lower abuse potential compared to schedule II and schedule IV opioids, with less likability, longer time to peak effect, fewer perceived good effects and more perceived bad effects than both oxycodone and tramadol. Specifically, maximum drug liking “at this moment” for both cebranopadol 600 μg and 1000 μg was significantly less than tramadol 600 mg (17.34 and 7.77 on the VAS, respectively; 95% confidence interval [CI]) and oxycodone 40 mg (24.43 and 14.86 on the VAS, respectively; 95% CI). Additionally, all key secondary endpoints were consistent with cebranopadol being less preferred, including that perceived “good drug effects” associated with both the 600 μg (24.7) and 1000 μg (43.8) doses of cebranopadol were lower than both oxycodone (69.6) and tramadol (54.3), while the perceived “bad drug effects” associated with cebranopadol 600 μg (12.8) and 1000 μg (23.7) were higher than both oxycodone (7.8) and tramadol (21.2). The difference between the good effects and bad effects of drugs have been linked to their abuse potential. Also, these data were consistent with the holistic measures “overall drug liking,” where subjects rated both doses of cebranopadol lower than either of the active comparators, and “take drug again,” where subjects indicated a reduced interest in taking cebranopadol again when compared to both oxycodone and tramadol. Based on previous studies suggesting cebranopadol provides relief for acute, chronic nociceptive and neuropathic pain that is on par with or superior to traditional opioids, these findings suggest the compound may serve as a much-needed alternative treatment option. “These data provide further evidence that, as the first dual-NMR analgesic, cebranopadol has the potential to deliver effective pain management without the level of addictive potential seen with schedule II and schedule IV drugs,” said Marc Lesnick, Ph.D., chief development officer at Tris Pharma. “We hope that these findings are encouraging for patients and clinicians who are awaiting new options and we look forward to initiating our phase 3 clinical trials.” About Cebranopadol (TRN-228) Cebranopadol is the first and only full, dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist (dual-NMR) analgesic in clinical development for the treatment of moderate to severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a compelling and truly unique mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of abuse while still providing effective pain relief, and to block drugs of abuse from producing drug-seeking behaviors. In 2017, the FDA granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s pro been well-characterized in pain management, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to traditional opioids with significantly less potential for abuse or risk of physical dependence, addiction or overdose. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at and on LinkedIn @TrisPharma.