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Prescription Medicines

REL-1017 (esmethadone; d-Methadone), a Rapid-Acting Antidepressant Has No Meaningful Opioid Abuse Liability in Nonclinical and Clinical Abuse Potential Studies

To be presented at the 84th CPDD Annual Scientific Meeting, June 11-15, 2022.

In a Phase 2 clinical trial REL-1017 showed rapid, robust, and sustained efficacy as adjunctive treatment for Major Depressive Disorder (MDD) without opioid-like side effects.

Prescription Medicines

CPDD 84th Annual Scientific Meeting

June 11-15, 2022 | MINNEAPOLIS, MN
Jack Henningfield, August Buchhalter, and Ryan Lanier will be attending CPDD.

Prescription Medicines

Comment to Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids (Docket No. CDC-2022-0024)

Schnoll S, Beck R, Henningfield J, Ashworth J. The 2022 revision is a positive step forward in addressing the challenges that worsened the disparities in access to pain medicines that resulted from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain – United States. READ OUR COMMENT

Dietary Ingredients & Supplements

Comment to FDA: World Health Organization ECDD Report Addressing the Review Status of Kratom and Its Alkaloids (Docket No. FDA-2022-N-0105)

Henningfield JE, Huestis MA, Grundmann O, Swogger MT, Prozialeck WC, Garcia-Romeu A, McCurdy CR. This is a collaborative comment of concerned scientists regarding the WHO ECDD report addressing the review status of kratom and its alkaloids. READ OUR COMMENT

CHPA Annual Self-Care Leadership Conference

Pinney Associates is a proud sponsor of the CHPA Annual Self-Care Leadership Conference, the industry’s leading event, once again convening the nation’s top consumer healthcare executives. View conference website

Prescription Medicines

The 2nd Annual Psychedelic Therapeutics & Drug Development Conference

MAY 23–24, 2022 | WASHINGTON, DC
Following a presentation of the results from a 2021 survey of key stakeholders which elicited expert opinions on best practices and metrics to assess the safety of psychedelic drugs within the context of a REMS, as well as the most effective structure for such programs (e.g., individual vs. shared REMS programs), panelists in this session will discuss the most relevant aspects for designing appropriate REMS programs for this new class of medicines.

Prescription Medicines

Psychedelic Drugs in the Post-Approval World: Important Components of Risk Evaluation and Mitigations Strategy (REMS) Programs to Protect Public Health while Ensuring Widespread Access

Coe M, Ashworth J, Schnoll S, Henningfield J. Under the Food and Drug Administration Amendments Act of 2007, the FDA can require the use of risk evaluation and mitigation strategies (REMS) over and above professional labeling, to ensure that a drug’s benefits outweigh its risks. As of August 2021, there were 314 listings on clinicaltrials.gov… Read More

Prescription Medicines

No Meaningful Opioid Abuse Liability of REL-1017 (esmethadone; d-methadone), a Rapid-Acting Antidepressant in Clinical Development: A Human Abuse Potential Study

Henningfield JE, Apseloff G, Gorodetzky C, Pappagallo M, Shram M, de Martin S, Fant RV, Vocci F, Sapienza F, Kosten T, Huston J, Buchhalter AR, Ashworth J, Lanier R, Folli F, Traversa S, Inturrisi CE, Manfredi PL. We aimed to assess the human abuse potential (HAP) of REL-1017 in a single-dose, randomized, double-blind, double dummy,… Read More