Morning Rounds: News From August 3-9

Pharmaceutical Updates

FDA Approves Orzeyful (Oveporexton) for Narcolepsy Type 1

The US Food and Drug Administration approved Takeda's Orzeyful (oveporexton) on August 5, an oral orexin receptor 2 agonist for narcolepsy type 1 in adults.¹ Unlike existing stimulant and wake-promoting therapies that address individual symptoms, Orzeyful is the first medication designed to target the orexin deficiency that drives the disorder. Approval rests on 2 12-week, placebo-controlled trials of 273 adults showing improvement across daytime sleepiness, cataplexy, and quality of life, with insomnia and urinary urgency as the most common side effects. A scheduling decision is still pending with the Drug Enforcement Administration before commercial launch. For clinicians managing patients with comorbid mood disorders and unexplained hypersomnia, this is a novel-mechanism option worth tracking once it reaches pharmacies.

VA Launches Psychedelics Trial for Veterans With Treatment-Resistant Depression and PTSD

The Department of Veterans Affairs announced partnership with Compass Pathways on PIVOT, a multisite, double-blind, randomized controlled trial of COMP360 psilocybin in at least 240 veterans with treatment-resistant depression, including many with co-occurring posttraumatic stress disorder (PTSD).² The trial will run through 2031 across 5 VA medical centers, comparing 2 psilocybin doses with an option for a second open-label administration, using the Montgomery-Asberg Depression Rating Scale as its primary outcome measure. Compass is donating the study drug and supporting clinician training; the collaboration follows a recent executive order directing federal agencies to accelerate psychedelic research. VA officials emphasized that this remains investigational and cautioned patients against self-medicating with unprescribed psychedelics.

FDA Decision Due This Week on First Tau-Targeted PET Imaging Agent

The FDA is set to decide on MK-6240 (florquinitau F-18), Lantheus's investigational tau-targeted PET imaging agent, on August 13.³ The tracer is designed to selectively bind aggregated tau neurofibrillary tangles with minimal off-target signal, distinguishing it from earlier-generation tau tracers. Its NDA is backed by 2 phase 3 trials that met coprimary endpoints for sensitivity and specificity. If approved, MK-6240 would give clinicians a tool to visualize tau pathology in patients with cognitive impairment being evaluated for Alzheimer disease, complementing amyloid PET and emerging blood-based biomarkers. Psychiatrists working in geriatric or memory-focused settings should watch for this decision, as it could affect diagnostic pathways and eligibility screening for emerging anti-tau therapies. MK-6240 already holds Fast Track designation and is in use across nearly 100 active clinical trials.

Clinical Research

Large RCT Shows Dronabinol Reduces PTSD-Related Nightmares

A randomized, placebo-controlled trial published last week found that dronabinol, an already FDA-approved synthetic THC medication, significantly reduced nightmare frequency and intensity in adults with PTSD.⁴ Researchers at Charité–Universitätsmedizin Berlin and collaborating German university hospitals enrolled 171 adults with PTSD and recurrent nightmares, randomizing them to nightly dronabinol (2.5–15 mg) or placebo for 10 weeks. Nightmare scores fell by 3.7 points in the dronabinol group versus 2.2 points with placebo, a statistically significant difference, and more than a third of dronabinol patients reported their nightmares stopped entirely. Overall PTSD severity and depression did not significantly improve, suggesting the benefit is specific to nightmares rather than broader symptom relief.

Policy & Legislation

Trial of Lindsay Clancy Renews Focus on Postpartum Psychosis Recognition and Treatment

As the trial of Lindsay Clancy—a former labor and delivery nurse charged in the deaths of her 3 children amid an alleged severe postpartum psychosis episode—continues, forensic and reproductive psychiatrist Susan Hatters-Friedman, MD, spoke with Psychiatric Times about what the case means for clinical practice.⁵ She emphasized that postpartum psychosis is a psychiatric emergency requiring inpatient treatment, that its waxing-and-waning course makes collateral information from family critical, and that a personal history of bipolar disorder raises risk by as much as 100-fold. She also renewed calls for postpartum psychosis to be added as its own diagnosis in the forthcoming DSM revision, arguing its absence undermines trainee education, research funding, and courtroom clarity when tragedies occur. For prescribers, the case is a reminder to proactively screen and educate patients and families about warning signs during pregnancy, not only after delivery.

Latest Federal and State Psychedelic Policy Moves

Two separate developments this week expand the regulatory runway for psychedelic-assisted therapy.⁶ On Capitol Hill, bipartisan House Armed Services Committee amendments would use the 2027 National Defense Authorization Act to extend military clinical trials of psilocybin and MDMA for active-duty service members, echoing the VA's parallel push into psilocybin research. Separately, a new Louisiana law funded by opioid-settlement dollars took effect this week, launching a tightly regulated clinical pilot program using psilocybin and related compounds for treatment-resistant mental health and substance use conditions.

References

1. FDA approves oveporexton for narcolepsy type 1, first drug to treat full range of NT1 symptoms. Psychiatric Times. August 5, 2026. https://www.psychiatrictimes.com/view/fda-approves-oveporexton-for-narcolepsy-type-1-first-drug-to-treat-full-range-of-nt1-symptoms

2. VA launches psilocybin trial for veterans with treatment-resistant depression. US Department of Veterans Affairs. August 5, 2026. Accessed August 10, 2026. https://news.va.gov/press-room/va-launches-psilocybin-trial-for-veterans-with-treatment-resistant-depression/

3. Lantheus announces FDA acceptance of New Drug Application for MK-6240, a PET imaging agent targeting tau in Alzheimer’s disease. October 28, 2025. Accessed August 10, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-new-drug-application-mk-6240

4. Roepke S, Schoofs N, Priebe K, et al. Dronabinol for nightmares in posttraumatic stress disorder: a randomized controlled trial. Nat Med. 2026.

5. Kuntz L, Hatters-Friedman S. Postpartum psychosis on trial: what the Lindsay Clancy case can teach us. Psychiatric Times. August 3, 2026. https://www.psychiatrictimes.com/view/postpartum-psychosis-on-trial-what-the-lindsay-clancy-case-can-teach-us

6. Gorsline J. Weekly psychedelic policy briefing - August 2, 2026. Psychedelics Today. August 2, 2026. Accessed August 10, 2026. https://psychedelicstoday.com/2026/08/03/psychedelic-policy-briefing-august-3-2026/