Events & Ideas

Marion Coe, Director, Clinical Development and Postmarketing Surveillance at Pinney Associates I support approval of midomafetamine (MDMA) capsules for the treatment of posttraumatic stress disorder (PTSD). This medication assisted therapy holds significant potential for public health benefit by providing an effective treatment for PTSD, a condition affecting millions of people. It is likely to contribute… Read More

Jack Henningfield, Vice President, Research Health Policy and Abuse Liability, Pinney Associates. I support the approval of MDMA for the treatment of post-traumatic stress disorder (PTSD). Phase 2 and 3 studies have demonstrated efficacy and, equally importantly, the studies have shown that it can be used safely under various conditions and approaches to therapeutic use… Read More

Authors:  Moline M, Cheng JY, Henningfield J, Sembower M, Pype S, Buchhalter AR Background: Drugs acting on the central nervous system are subject to a determination of abuse potential prior to regulatory approval in the United States (US). Since the dual orexin antagonists (DORAs) are hypnotics, each approved drug (lemborexant, suvorexant, daridorexant) underwent a comprehensive… Read More

Pappagallo M, Shram M, Henningfield J, Gorodetsky C, De Martin S, Vocci F, Sapienza F, Kosten T, Guidetti C, O’Gorman C, Folli F, Traversa S, Inturrisi C, Manfredi P Background: Esmethadone (REL-1017) is a promising adjunctive antidepressant candidate currently in Phase 3 development as an N-methyl-D-aspartate receptor uncompetitive antagonist. It is the dextro-isomer of racemic… Read More

December 3-6, 2023 | Tampa, FL Jack Henningfield will be attending. VIEW CONFERENCE Posters:No Indication of Abuse or Withdrawal Potential with Esmethadone (REL-1017): Results From Two Phase 3 Randomized Placebo-Controlled Trials in Patients With Major Depressive Disorder Nonclinical Studies of Abuse Potential With Dual Orexin Receptor Antagonists: Concordance With Real-World Use

October 19-20, 2023 | San Diego, CA Judy Ashworth and Ryan Lanier will be attending and participating in a panel session. VIEW CONFERENCE Panel Session:Overview of the Current Regulatory Landscape and Challenges in the Development of New Safer and Effective Analgesic Drugs

Panel Session CHAIR: Judy Ashworth, MD, Senior Vice President, Pinney Associates Panelists: Ryan Lanier, Director, Clinical Development & Abuse Liability, Pinney Associates Marc Lesnick, Ph.D., Chief Development Officer, Tris Pharma Jeff Reich, MD, Co-founder & CEO, Sparian Biosciences There is a high unmet medical need to develop new effective analgesics that offer safety advantages over… Read More

September 10-12, 2023 | Bellevue, WA Jack Henningfield will be attending and participating in a panel discussion. VIEW CONFERENCE Discussion: Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an Example 2 – The Current Regulatory 8-Factor… Read More