Psychiatry Month in Review: March 2024

With March came a plethora of successful trials in psychiatry, from the US Food and Drug Administration (FDA) granting a breakthrough designation to MM120 for anxiety to drugs for PTSD and treatment-resistant depression showing promise in the early stages of research.

This month in review highlights phase 2 data and a piece for International Women’s day on how women experience more burnout than men.

FDA Grants MM120 for Anxiety Breakthrough Designation

Daniel Karlin, MD: FDA Grants Breakthrough Designation to MM120 for Anxiety

The FDA granted MindMed a breakthrough therapy designation for MM120 (lysergide d-tartrate or LSD) for generalized anxiety disorder (GAD) after a phase 2B trial met its secondary endpoint. The trial demonstrated a single oral dose of MM120, 100 µg had clinically and statistically significant durability with a 7.7-point improvement over placebo at week 12 (P <.003), following a 7.6-point improvement at week 4. MindMend plans on holding an end-of-phase 2 meeting with the FDA to discuss the next steps.

“Now, [the FDA Breakthrough is] not the same as a drug approval—it doesn't give us marketing authorization; it doesn't make mm120 an available drug—but what it is an acknowledgment of is that FDA agrees it has the potential to meet an unmet medical need,” investigator Daniel Karlin, MD, said in an interview with HCPLive.

Related content: Daniel Karlin, MD: Topline MM-120 Data for Generalized Anxiety Disorder

Other Clinically Meaningful Phase 2 Data

BPL-003 Shows Rapid Antidepressant Effect for Treatment-Resistant Depression

A new study found a single 10 mg dose of BPL-003, a synthetic, benzoate salt formulation of 5-MeO-DMT (mebufotenin) demonstrated a rapid and durable antidepressant effect in treatment-resistant depression patients. More than half (55%) of participants achieved a clinical response the day after their first dose. The positive results came from Beckley’s Psytech’s phase 2a open-label study of BL-003 which followed participants up to 12 weeks with several assessments throughout. The team observed 55% of participants achieved remission at week 4 with 45% in remission at week 12.

The trial also found BPL-003 has a good safety profile and was well-tolerated with no serious adverse events. Any acute effects were resolved in less than 2 hours, on average. Atai Life Sciences is currently enrolling participants for a part 2 extension of the trial and is actively working on a randomized, quadruple-masked, controlled phase 2b study.

BNC210 Brings Significant Improvement in PTSD Symptom Severity

The drug BNC210 demonstrated a statistically significant improvement in PTSD symptom severity with a rapid onset of clinical efficacy by week 4 (P < .05) and improvements continuing through week 8 (P < .05) and 12 (P < .05). The clinically meaningful effect size suggests the drug could have a potential advantage over current on-the-market medications. BNC210 also has a good safety and tolerability profile, indicating it could be more effective than other PTSD medications.

The data came from a phase 2b double-blind, placebo-controlled trial where participants aged 18 – 75 years were randomized 1:1 to receive either 90 mg twice daily of BNC210 or placebo.

Women Are More Burnout Than Men

Women Experience Worse Mental Health, Burnout Than Men

Female healthcare workers face significantly more stress and burnout than male coworkers. Factors attributing to women’s burnout include poor work-life balance, having less professional autonomy than their male colleagues, and structural gender discrimination. Women may feel pressured to meet societal caregiver expectations. Interventions such as flexible work schedules, expanded parental leave policies, professional development opportunities during the regular workday, and opportunities for professional recognition can help reduce harmful stress, increase job satisfaction, and improve work-life balance.

In an interview with HCPLive, Viktoriya Karakcheyeva, MD, MS, NCC, LCP-SP, LCADAS, from the GW Resiliency & Well-Being Center at George Washington University, talked about the burnout women healthcare workers experience. In another interview, Emily Bernstein, MD, from Rittenhouse Psychiatric Associates, talked about how a survey saw a greater number of women reported needing mental health services in the past 2 years than men.

Related Content: Women Working in Healthcare Have Significantly More Burnout Than Men Colleagues