The FDA’s approval of Cobenfy (xanomeline and trospium chloride) at the end of September was an important moment in psychopharmacology, ushering in the first truly “new” schizophrenia medication in decades. But Cobenfy was not the only new psychiatric treatment to join the armamentarium. In case you missed it, here are some other FDA approvals, clearances, new formulations, and expanded indications from this past year:
March
FDA approves Risvan, a once-monthly risperidone injectable, for the treatment of schizophrenia that does not require a loading dose, enabling seamless switching from oral to injectable treatment.
April
FDA clears Rejoyn—a smartphone-based therapeutic app—as an adjunct treatment of major depressive disorder among adults ages 22 years and older who are using antidepressant medication.
FDA also clears Mama Lift Plus, a prescription digital therapeutic that offers behavioral therapy as an adjunct to clinician-managed outpatient care for patients 22 years of age and older with mild to moderate postpartum depression.
FDA approves Rezenopy, a high-dose naloxone hydrochloride nasal spray, for the treatment of known or suspected opioid overdose in adults and children.
FDA expands the approval of Fanapt (iloperidone) to include the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
FDA approves a new “sprinkle” formulation of Ingrezza (valbenazine) for patients with tardive dyskinesia or Huntington’s chorea who may have difficulty swallowing.
FDA clears Modius Stress, an at-home transdermal neurostimulation device, for the treatment of generalized anxiety disorder among adults ages 22 years and older.
May
FDA approves Onyda XR, an extended-release oral suspension of clonidine, for the treatment of ADHD among pediatric patients 6 years of age and older; Onyda is the first liquid non-stimulant medication available for ADHD.
FDA approves new once-daily tablets of Austedo XR (deutetrabenazine) in doses ranging from 30 to 48 mg. Austedo was approved in 2023 (up to 24 mg) for the treatment of tardive dyskinesia and chorea in adults.
June
FDA clears Endeavor—previously a prescription-only video game–based therapeutic for the treatment of ADHD—as an over-the-counter treatment.
July
FDA approves Kisunla (donanemab), the third antibody-based treatment for early Alzheimer’s disease. Donanemab is the first Alzheimer’s treatment that is delivered in monthly rather than biweekly infusions.
FDA approves Erzofri, a monthly extended-release injectable suspension of paliperidone palmitate, for the treatment of schizophrenia and schizoaffective disorder in adults.
FDA approves Zunveyl (benzagalantamine) for the treatment of mild to moderate Alzheimer’s disease; Zunveyl is a modified form of galantamine that has reduced gastrointestinal side effects.
August
FDA approves Zurnai, a pre-filled nalmefene hydrochloride auto-injector, for the treatment of known or suspected opioid overdose in people at least 12 years old.
FDA approves Crexont for the treatment of Parkinson’s disease; Crexont is a novel formulation of carbidopa and levodopa that combines both immediate-release granules and extended-release pellets.
September
FDA clears DaylightRx, a prescription digital therapeutic that delivers cognitive behavioral therapy as an adjunct to usual care in the treatment of generalized anxiety disorder in patients 22 years old or older.
October
FDA approves Vyalev (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
FDA expands the approval of Lumryz, an oral suspension of sodium oxybate, for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients ages 7 years or older.
(Image: Getty Images/iStock/JHVEPhoto)
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