Morning Rounds: News from May 4-May 8
Key Takeaways
- HHS’s initiative prioritizes expanded informed consent, shared decision-making, and nonpharmacologic options, while formalizing deprescribing guidance that may intensify scrutiny of SSRIs and pediatric use.
- Nebraska’s Medicaid work requirements create a real-world stress test, with medically frail exemptions evolving and potential continuity-of-care gaps for serious mental illness and addiction populations.
Review news from the last week in psychiatry.
We saw impactful new developments in federal policy and pharmaceutical approvals last week. Read the top stories below.
Policy & Legislation
US HHS Announces Plan to Promote “Appropriate Psychiatric Prescribing”
The US Department of Health and Human Services (HHS) announced a new federal initiative aimed at reducing what agency leaders characterized as psychiatric “overprescribing,” with a particular emphasis on antidepressant use and deprescribing strategies when clinically indicated.1 The action plan, introduced by HHS Secretary Robert F. Kennedy Jr, promotes expanded informed consent, shared decision-making, and increased use of nonpharmacologic interventions such as psychotherapy, exercise, nutrition, and social support.
Nebraska Becomes First State to Enforce Medicaid Work Requirements—Psychiatric Patients Among Most Vulnerable
Nebraska is now the first US state to implement Medicaid work requirements under federal policy of the One Big Beautiful Bill Act.3 Beginning this month, many adults enrolled through the state’s Medicaid expansion program must demonstrate employment, volunteer participation, educational enrollment, or qualifying exemptions to maintain eligibility.4 Exceptions exist for individuals deemed medically frail and for some patients receiving addiction treatment services, although implementation details remain under development. Policy analysts have cautioned that disruptions in Medicaid coverage could disproportionately affect individuals with serious mental illness, substance use disorders, and limited access to continuity of psychiatric care. The Nebraska rollout is expected to serve as a national test case as additional states prepare for implementation of similar requirements in 2027.
Pharmaceutical Updates
FDA Extends Leqembi SC Autoinjector Review by 3 Months—PDUFA Pushed to August 24
Biogen and Eisai announced that the US Food and Drug Administration (FDA) extended review for the supplemental biologics license application (sLBA) for weekly subcutaneous autoinjector initiation dosing of Leqembi.5 The new Prescription Drug User Fee Act target action date is August 24, 2026. The FDA requested additional information constituting a major amendment to the sLBA, but did not raise any concerns to the approvability of Leqembi IQLIK as a starting dose. Existing intravenous lecanemab therapy has generated substantial clinical interest because of its modest slowing of cognitive decline alongside ongoing concerns regarding amyloid-related imaging abnormalities, infusion burden, and patient selection.6
Vistagen Completes Last Patient Visit in PALISADE-4 Trial for Social Anxiety Disorder
Vistagen Therapeutics announced completion of the last patient visit in PALISADE-4, its ongoing phase 3 trial evaluating intranasal fasedienol for the acute treatment of social anxiety disorder (SAD).7 The PALISADE-4 study is a registration-directed, randomized, double-blind trial using a public-speaking challenge paradigm to assess rapid anxiolytic effects in adults with SAD. Fasedienol is a neuroactive pherine administered intranasally and is intended to modulate neural circuitry through olfactory pathways without meaningful systemic absorption. The company indicated that topline efficacy and safety results are expected in the first half of 2026, positioning the program as a potentially pivotal regulatory milestone. Earlier PALISADE studies produced mixed findings, with PALISADE-2 reporting positive phase 3 results while PALISADE-3 failed to meet its primary endpoint despite a favorable tolerability profile.8
Upcoming FDA Decision Date for CTx-1301 in ADHD
The FDA is expected to issue a regulatory decision by May 31, 2026, regarding CTx-1301, an investigational dexmethylphenidate formulation developed for treatment of attention-deficit hyperactivity disorder.9 Developed by Cingulate Therapeutics, CTx-1301 uses a “precision timed release” delivery platform designed to provide rapid onset and symptom control across the full waking day with once-daily dosing. Phase 3 data reportedly demonstrated statistically significant improvements in ADHD symptom measures and extended-duration efficacy. Regulatory review will likely focus on efficacy durability, abuse liability considerations, and comparative tolerability relative to currently available stimulant products.
Clinical Research
Psilocybin Shows Early Signal in Cocaine Use Disorder Trial
A randomized clinical trial published last week in JAMA Network Open reported preliminary evidence supporting psilocybin-assisted therapy for treatment of cocaine use disorder. Investigators randomized 40 participants and found that patients receiving psilocybin with psychotherapy demonstrated statistically significant reductions in cocaine use and improvements in abstinence-related outcomes over 180 days of follow-up. Findings add to a growing body of literature examining psychedelic-assisted interventions across substance use and mood disorders. The study highlights increasing momentum toward novel neuropsychiatric therapeutics targeting refractory addiction syndromes, although larger confirmatory studies remain necessary before routine clinical implementation.
References
1. Kuntz L. HHS launches action plan to promote “appropriate psychiatric prescribing.”Psychiatric Times. May 5, 2026.
2. APA welcomes national focus on mental health, urges evidence-based approach and continued focus on access to care. American Psychiatric Association. May 4, 2026. Accessed May 8, 2026.
3. Galewitz P. It’s day 1 of Medicaid work requirements in Nebraska. People are worried. NPR. May 1, 2026. Accessed May 8, 2026.
4. Davis J, News M, Waldo K. Ready, set, go: implementation of Medicaid work requirements is on its way. JD Supra. May 7, 2026. Accessed May 8, 2026.
5. Update on FDA priority review of Leqembi IQLIK (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease. Press release. May 8, 2026. Accessed May 8, 2026.
6. Leqembi study results. Press release. August 2025. Accessed May 8, 2026.
7. Vistagen announces completion of last patient visit in PALISADE-4 phase 3 public speaking challenge study of fasedienol for acute treatment of social anxiety disorder. Press release. May 8, 2026. Accessed May 8, 2026.
8. Vistagen announces topline results from PALISADE-3 public speaking challenge study of fasedienol for the acute treatment of social anxiety disorder. Press release. December 17, 2025. Accessed May 8, 2026.
9. FDA accepts Cingulate’s New Drug Application for CTx-1301 in attention-deficit/hyperactivity disorder (ADHD) and sets a May 31, 2026 PDUFA date.
10. Hendricks PS, Lappan SN, Shelton RC, et al.
