Week in Review: February 10-14

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This week, Psychiatric Times discussed a variety of psychiatric issues and industry news, including updates from the 30th Annual Nevada Psychiatric Association National Psychopharmacology Update.

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A Love Letter to My Workplace: An Ethical Model of Private Practice for Clinician and Patient Well-Being

In October 2022, Layne A. Gritti, DO, completed her addiction psychiatry fellowship, seeking a position that offered flexible scheduling, remote work, reasonable vacation time, competitive pay, and a focus on addiction and reproductive mental health. After numerous interviews left her disillusioned, she joined a private practice that prioritized both clinician and patient well-being. This practice emphasized ethical care, work-life balance, and professional autonomy, allowing Gritti to thrive in her specialties while maintaining personal fulfillment. Her experience underscores the importance of workplace environments that support clinicians' needs, ultimately enhancing patient care. Read more.

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CYB003 for the Adjunctive Treatment of Major Depressive Disorder

CYB003, a deuterated psilocybin analog, is under investigation as an adjunctive treatment for major depressive disorder (MDD) in the PARADIGM phase 3 program. This program comprises 3 pivotal studies—APPROACH, EMBRACE, and EXTEND—targeting patients with moderate to severe MDD who have not adequately responded to current antidepressants. In phase 2 trials, CYB003 demonstrated significant symptom improvement and high remission rates, supporting the design and focus of the phase 3 studies. Read more.

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First Patient Dosed in Second Phase 3 Study of Psychedelic MM120 for Generalized Anxiety Disorder

MindMed has initiated its second phase 3 clinical trial, named Panorama, evaluating MM120 (lysergide D-tartrate) for generalized anxiety disorder (GAD). The first patient has been dosed in this trial, which aims to enroll approximately 250 participants. The study introduces a 50µg dose to minimize unblinding bias and enhance result reliability. The primary endpoint is the change in anxiety scores at week 12. MM120, delivered as an orally disintegrating tablet using Zydis technology, offers rapid absorption and has received FDA Breakthrough Therapy Designation. Current GAD treatments are limited, highlighting the potential impact of MM120 ODT as a transformative option. Read more.

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SPN-820 Shows Rapid and Significant Improvement in MDD Symptoms

A recent phase 2 open-label clinical trial has demonstrated that SPN-820, a novel antidepressant, provides rapid and substantial improvement in adults with MDD. Patients taking SPN-820 alongside their existing antidepressant medication showed significant symptom relief within hours of administration, with continued progress over the study period. SPN-820 is an oral formulation of NV-5138 with a novel mechanism of action. Read more.

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Xanomeline and Trospium Improves Social Functioning and Life Engagement in Schizophrenia: EMERGENT Trials Analysis

The EMERGENT trials, comprising 3 5-week, double-blind, placebo-controlled studies, evaluated the efficacy of xanomeline and trospium in 640 participants experiencing acute exacerbations of schizophrenia. Participants were randomized to receive either the combination treatment (314 individuals) or a placebo (326 individuals), with dosages titrated up to 125 mg of xanomeline and 30 mg of trospium twice daily. The results indicated that those treated with xanomeline and trospium experienced significant improvements in social functioning and life engagement compared with the placebo group. These findings suggest that the combination therapy may offer a promising approach to enhancing social interactions and overall engagement in life for individuals with schizophrenia. Read more.

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Patent Issued for Methods of Identifying Patients with Substance Use-Associated Genetic Markers, Treatment With AD04

Adial Pharmaceuticals has been granted US patent number 12,221,654, covering methods for identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04. AD04 is a selective serotonin-3 receptor antagonist targeting individuals with the TT genotype of rs1042173 in the serotonin transporter gene. This personalized approach aims to enhance treatment efficacy for opioid and alcohol use disorders. Pharmacokinetic studies support AD04's micro-dosing regimen, showing favorable safety and tolerability profiles. This development underscores the potential of genotype-guided therapies in addressing substance use disorders. Read more.