Psychiatry in the News: December 2023

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Here’s some news you may have missed in the world of psychiatry from throughout the month of December, as featured in Psychiatric Times®.

NDA Submitted for MDMA-Assisted Therapy for Posttraumatic Stress Disorder

MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for midomafetamine capsules (MDMA) used in combination with psychotherapy for individuals with posttraumatic stress disorder (PTSD). If approved, this would be the first official psychedelic-assisted therapy.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” said Amy Emerson, chief executive officer of MAPS. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.” Continue Reading

Positive Topline Results Announced for Phase 2b Clinical Trial of GAD Treatment

The topline results from a phase 2b clinical trial of lysergide d-tartrate (MM-120) for generalized anxiety disorder (GAD) announced today demonstrated that the trial met its primary endpoint.

MindMed, the developer of MM-120, announced that the trial—Study MMED008—successfully met its primary endpoint by demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety Rating Scale (HAM-A) compared when placebo at week 4. Administered as a single dose in a monitored clinical setting with no additional therapeutic intervention, MM-120 exhibited promising outcomes. Continue Reading

New Data on Esketamine Nasal Spray as Treatment for Adolescents Contemplating Suicide

Suicide is a leading cause of death among adolescents worldwide. According to the Centers for Disease Control and Prevention, as of 2020, 18.8% of high-school students reported seriously considering suicide and 8.9% have made an attempt. Up to 80% of adolescents who attempt suicide meet criteria for major depressive disorder (MDD) at the time of the suicide attempt and up to 60% of adolescents who die by suicide have a depressive disorder. There is no approved pharmacological treatment for adolescents who urgently need rapid depressive symptom relief.

Studies in adults with MDD experiencing acute suicidal ideation and behavior showed that esketamine nasal spray, added to a SSRI or SNRI oral antidepressant, resulted in significant reduction of depressive symptoms within 24 hours of receiving treatment. These results inspired us to study esketamine in suicidal adolescents with MDD, a vulnerable and understudied population with great unmet medical need. Continue Reading

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