FDA Roundup: Implications of Potential MDMA Approval, Nalmefene for Opioid Overdose

As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?

The FDA’s decision on a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) is quickly approaching, with a Prescription Drug User Fee Act (PDUFA) date set for August 11. The agency’s verdict has been highly anticipated and could mark a historic shift in psychedelic medicine, as it would be the first psychedelic-assisted therapy approved in the United States.

In an interview with Drug Topics, Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discussed how MDMA's approval would impact the current landscape of mental health treatment, how it could affect public perception and stigma surrounding psychedelic drugs, if an approval could set a precedent for other psychedelic therapies, and how the psychedelic therapy community would be impacted if the FDA declined approval.

FDA Approves Nalmefene Injection for Opioid Overdose

The FDA approved nalmefene injection (Zurnai) for the emergency treatment of known or suspected opioid overdose caused by natural or synthetic opioids in adult and pediatric patients aged 12 years and older. Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector. It delivers 1.5 mg of the medication per actuation and is intended for subcutaneous or intramuscular delivery.

FDA Approves Extended-Release Parkinson Medication From Amneal Pharmaceuticals

Amneal Pharmaceuticals announced that the FDA has approved its extended-release carbidopa and levodopa (CD/LD, [IPX203]) capsules, marketed as Crexont, for the treatment of Parkinson’s disease. The approval was supported by data from the 20-week, randomized, double-blind, double-dummy, active-controlled phase 3 RISE-PD (NCT03670953) clinical trial, with results published in JAMA Neurology.

FDA Approves Immunotherapy to Treat R/R Cutaneous T-Cell Lymphoma

The FDA approved denileukin diftitox-cxdl (Lymphir) for the treatment of relapsed or refractory cutaneous T-cell lymphoma in adult patients after at least 1 prior systemic therapy, Citius Pharma announced in a release.1 Lymphir is a novel immunotherapy that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The approval was based on data from the phase 3 302 study (NCT01871727), in which the therapy demonstrated a median time to response of 1.41 months, a duration of response of at least 6 months for 52% of patients, and an 84.4% decrease in skin tumor burden and a 12.5% complete clearing of skin disease in skin evaluable subjects.

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References

1. Citius Pharmaceuticals Receives FDA Approval for LYMPHIR™ (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma. News Release. Citius. August 8, 2024. Accessed August 9, 2024. https://www.prnewswire.com/news-releases/citius-pharmaceuticals-receives-fda-approval-for-lymphir-denileukin-diftitox-cxdl-immunotherapy-for-the-treatment-of-adults-with-relapsed-or-refractory-cutaneous-t-cell-lymphoma-302217630.html