This month in review covers key psychiatry updates, including the latest FDA decisions, antidepressant use in pregnancy, and the latest episode of Medical Ethics Unpacked.
Credit: HCPLive
February brought significant developments in psychiatry, spanning antidepressant use during pregnancy to headache-related suicide risk, and new data on treatment-resistant depression (TRD). A new investigation revealed a nearly 50% drop in antidepressant prescriptions during pregnancy without a compensatory rise in psychotherapy and a Danish cohort study identified a troubling link between headache diagnoses and increased suicide risk. On the drug development front, hopes for SPN-820 as a novel treatment for TRD were tempered after a Phase 2b trial failed to show significant symptom improvement.
Regulatory updates featured prominently, with the US Food and Drug Administration (FDA) granting key approvals and label expansions in psychiatric and addiction treatment, including buprenorphine extended-release injection (SUBLOCADE) for opioid use disorder (OUD) and risperidone extended-release injectable suspension (UZEDY) for the treatment of bipolar I disorder.
Beyond clinical developments, ethical and policy discussions also took center stage. A recent episode of Medical Ethics Unpacked explored the increasing demand and access challenges surrounding glucagon-like peptide-1 receptor agonists (GLP-1 RA). As the field continues to navigate complex issues in psychiatric treatment, regulation, and ethics, February’s developments underscore the ongoing need for research, policy evolution, and patient-centered care strategies.
Here’s what happened in February:
Antidepressant Use Drops During Pregnancy Without Psychotherapy Increase
A new investigation pointed to a large decrease in antidepressant use during pregnancy without a subsequent increase in psychotherapy. In the year before pregnancy, approximately 4% of women in a large claims database filled an antidepressant prescription, but this dropped to 2.2% during pregnancy, representing a reduction of nearly 50%.
Headache Diagnoses Linked to Increased Suicide Risk
A strong link was identified between headache diagnoses, including tension-type headaches, and attempted or completed suicide attempts. In the population-based cohort study of Danish citizens, the 15-year risk of attempted suicide for people with headache diagnosis was 0.78%, compared with 0.33% for individuals without diagnosis. The 15-year risk of completed suicide was 0.21% and 0.15%, respectively.
SPN-820 Fails Phase 2b Trial for Treatment-Resistant Depression
Topline results from a Phase 2b trial found SPN-820 did not significantly improve the total Montgomery-Åsberg Depression Rating Scale (MADRS) score for patients with TRD. Previous results reported by Supernus Pharmaceuticals in an open-label Phase 2a trial were positive, showing a significant rapid antidepressant effect on depressive symptoms and suicidal ideation within 2 hours of administration in patients with major depressive disorder (MDD).
FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment
The FDA approved the label change for buprenorphine extended-release injection (SUBLOCADE) to treat opioid use disorder (OUD), expanding the approved subcutaneous injection site of the abdomen to the thigh, buttock, and back of the upper arm. The updated label also allows for a rapid initiation protocol, with providers able to treat with buprenorphine extended-release injection after a single dose of transmucosal buprenorphine and a one-hour observation period to determine tolerability.
FDA Accepts sNDA for Risperidone Extended-Release Injectable Suspension for Bipolar I Disorder
The FDA accepted Teva Pharmaceuticals and Medincell’s supplemental New Drug Application (sNDA) for risperidone (UZEDY) extended-release injectable suspension for the treatment of adults with bipolar I disorder. The company’s sNDA was submitted based on existing risperidone clinical data, as well as previous findings on the safety and efficacy of previous risperidone formulations approved for bipolar I disorder treatment.
Medical Ethics Unpacked: GLP-1 Allocation and Challenges of Equitable Access
In the latest episode of Medical Ethics Unpacked, hosts Steve Levine, MD and Dominic Sisti, PhD are joined by Johan Dellgren, BA, a research fellow at the University of Pennsylvania’s Department of Medical Ethics and Health Policy, to explore the ethical and policy challenges surrounding the allocation of GLP-1 receptor agonists, a class of medications widely recognized for their effectiveness in treating diabetes and obesity and experiencing a notable growth in demand.
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