Psychiatry Month in Review: July 2024

This Month in Review for July encompasses the top US Food and Drug Administration (FDA) news, pipeline updates, and discovered associations in the psychiatry field. The recap also captures insights from psychiatry experts on topics ranging from schizophrenia to PTSD. On the latter subject, the Month in Review includes commentary from a psychiatry expert on the potential game-changer MDMA-assisted therapy, with an FDA decision now less than a month away in August.

Pipeline Updates

FDA Approves Paliperidone Palmitate for Schizophrenia, Schizoaffective Disorder

Luye Pharma Group announced on July 29, 2024, that the FDA approved paliperidone palmitate (ERZOFRI), an extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults, both as monotherapy and adjunctive to mood stabilizers or antidepressants. Developed and patented in China, it received a US patent in 2023, expiring in 2039.

Now, paliperidone palmitate is approved as a new drug in the US. The approval is based on a study of 281 patients comparing its pharmacokinetics and bioavailability to INVEGA SUSTENA.

J&J Submits sNDA for Esketamine Monotherapy in Treatment-Resistant Depression

Johnson & Johnson announced on July 22, 2024, the submission of a supplemental New Drug Application (sNDA) to the FDA for the approval of esketamine (SPREVATO), a CIII nasal spray, as a monotherapy for adults with treatment-resistant depression. The submission is backed by over a decade of research, 31 clinical trials, and 5 years of real-world data demonstrating SPREVATO’s safety and efficacy. Previously, SPREVATO was approved as an adjunct to oral antidepressants for treatment-resistant depression and as a monotherapy for major depressive disorder.

Clinical Trials and Discovered Associations

Taking Both CYP2D6 Opioids and Antidepressants Leads to Risk for Older Adults

The concomitant use of CYP2D6-metabolized opioids and CYP2D6-inhibiting antidepressants among nursing home residents is linked to worse pain and increased risk for opioid-related adverse events, a retrospective cohort study found. The study included 28,123 residents on Medicare aged ≥ 65 years.

Investigators compared the use of CYP2D6-inhibiting antidepressants with CYP2D6-neutral antidepressants when taken alongside opioids. Compared to the neutral group, those on CYP2D6-inhibiting antidepressants experienced worse pain, higher rates of pain-related hospitalization, pain-related emergency department visits, and opioid use disorder (all P < .001).

Healthy Prenatal Dietary Pattern Linked to Lower Odds of Child Having Autism

A study found an association between an expecting mother following a healthy prenatal dietary pattern and their child having lower odds of an autism diagnosis (odds ratio [OR], 0.78; 95% confidence interval [CI], 0.66 – 0.92) and social communication difficulties at 3 years (OR, 0.76; 95% CI, 0.70 – 0.82) and 8 years old (OR, 0.74; 95% CI, 0.33 – 0.98. A healthy prenatal dietary pattern was determined to be high in fruits, vegetables, fish, nuts, and whole-green foods, and low in red and processed meats, soft drinks, and foods high in fats or refined carbohydrates.

Insights from Psychiatry Experts

Improving Schizophrenia Management: A Patient's Call to Care Providers

A patient shares his journey with schizophrenia, starting from his diagnosis to the stigma and challenges he has experienced along the way. Schizophrenia experts Sam Clark, MD, PhD, the founder and CEO of Terran Biosciences, and Christoph Correll, MD, a professor of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, weigh in about the stigma and misconceptions surrounding schizophrenia, medications on the market, and treatments on the horizon such as KarXT.

The Trigger of Fourth of July Fireworks for Veterans with Christopher Scuderi, DO

Ahead of the Fourth of July, HCPLive spoke with Christopher Scuderi, DO, a Jacksonville primary-care family physician and a fellow veteran, about how people with PTSD triggered by fireworks can best prepare before the festive fireworks. Scuderi suggested getting noise-canceling ear plugs, having full mirror plugs darkening the room, and placing items around the house to remind you are in a safe place, among other things.

Boadie Dunlop, MD: Take on Future of MDMA-Assisted Therapy Ahead of FDA Verdict

Expert Boadie Dunlop, MD, professor of psychiatry and behavioral sciences at Emory University School of Medicine, discussed with HCPLive the future of MDMA-assisted therapy ahead of the FDA’s final decision in August.

“It's setting a precedent for a lot of new compounds that are going to come through the pipeline that really do have the opportunity or potential to enhance care in ways we haven't been able to do,” Dunlop said. “I'm sure the FDA wants to try to help facilitate it, but they also [are] going to be mindful about harms, and it's going to be a precedent-setting decision either way that they decide.”