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The Week in Review: January 27-31

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Key Takeaways

  • The FDA updated Qelbree's label to include new pharmacodynamic and lactation data, indicating minimal infant exposure during breastfeeding.
  • Neurocrine Biosciences' phase 3 trial for osavampator aims to address unmet needs in major depressive disorder treatment.
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Here are highlights from this week in Psychiatric Times, including FDA news and a look back at Psychiatric Times through the years.

Ronstik/Adobe Stock

Ronstik/Adobe Stock

This week, Psychiatric Times discussed a variety of psychiatric issues and industry news, including updates from the US Food and Drug Administration (FDA) and insights from a Montana county looking to better resident access to mental health care.

New Africa/Adobe Stock

New Africa/Adobe Stock

Label Update for ADHD Treatment Qelbree: New Pharmacodynamic Data and Breastfeeding Information

The FDA updated the label for viloxazine extended-release capsules (Qelbree), a nonstimulant treatment for attention deficit/hyperactivity disorder (ADHD), to include new pharmacodynamic and lactation data. The updated label indicates that viloxazine acts as a partial agonist at the serotonin 5-HT2C receptor and inhibits the norepinephrine transporter. A study involving 15 lactating women demonstrated low transfer of violoxazine into breast milk, resulting in minimal infant exposure. Read more.

Dzmitry/AdobeStock

Dzmitry/AdobeStock

Phase 3 Study Initiated: Osavampator as Adjunctive Therapy for Major Depressive Disorder

Neurocrine Biosciences has initiated a phase 3 clinical trial to assess the efficacy, safety, and tolerability of osavampator as an adjunctive treatment for adults with major depressive disorder (MDD), enrolling adults who have not adequately responded to current oral antidepressants. Osavampator showed significant improvements from baseline in Montgomery Åsberg Depression Rating Scale scores during phase 2 trials and was generally well tolerated, with headache being the most common adverse event. The phase 3 study aims to further evaluate its potential to address unmet needs in MDD treatment. Read more.

MargJohnsonVA/AdobeStock

MargJohnsonVA/AdobeStock

Mental Illness is an Equal Opportunity Employer

In this installment of Tales from the Clinic: The Art of Psychiatry, Danielle Egbe, CO, and Christina B. Smith, MD, discuss how affluence can contribute to mental health challenges. Despite financial stability, wealthy individuals may experience increased stress, anxiety, and a diminished sense of purpose. Pressures to achieve and social isolation can lead to depression and substance misuse. There is a tendency among affluent patients to overutilize expensive treatments, potentially overshadowing standard therapies like medication and psychotherapy. Read more.

Cagkan/AdobeStock

Cagkan/AdobeStock

BPL-003 for Alcohol Use Disorder: Positive Topline Results of Phases 2A Study

Beckley Psytech announced positive topline results from their open-label phase 2A study of BPL-003 in participants with moderate-to-severe alcohol use disorder, showing that treatment with BPL-003 can induce meaningful and sustained reductions in alcohol use and heavy drinking days for up to 3 months following a single dose. BPL-003 is a novel synthetic intranasal formulation of 5-MeO-DMT benzoate, designed to deliver rapid and durable efficacy with a short clinic time. The study reported BPL-003 as well-tolerated, with only mild to moderate adverse events and rapid patient discharge readiness. The study evaluated 12 enrolled patients who received a single dose given in combination with relapse prevention cognitive behavioral therapy. Read more.

Speedfighter/AdobeStock

Speedfighter/AdobeStock


Montana’s Mental Health Crisis: How One County’s Mobile Crisis Response Team is Filling Gaps and Saving Lives

Montana faces significant challenges in mental health care, ranking 50th out of 51 in adult mental health services. To address this, Gallatin County's Mobile Crisis Response Team collaborates with local law enforcement and health services to provide immediate assistance to individuals in crisis. This partnership has reduced law enforcement involvement in mental health calls and improved connections to appropriate resources. Innovative approaches include offering mental health evaluations in correctional facilities and proactive outreach in shelters, enhancing access to care and filling critical gaps in the county's crisis response system. Read more.

Celebrating 40 years with Psychiatric Times

Celebrating 40 years with Psychiatric Times

Psychiatric Times Through the Years: The last 5 Years in January Covers

From the beginning of the COVID-19 pandemic to emerging treatments for schizophrenia and PTSD, Psychiatric Times is celebrating 40 years with a look back at the last 5 yeas of January covers. Read more.

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