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Review
. 2024 Mar 20;16(3):e56561.
doi: 10.7759/cureus.56561. eCollection 2024 Mar.

A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022)

Affiliations
Review

A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022)

Shannon Giliberto et al. Cureus. .

Erratum in

Abstract

Mental health disorders are among the top leading causes of disease burden worldwide and many patients have high levels of treatment resistance. Even though medications offer improvement to some patients, antidepressants are only effective in about half of those treated, and schizophrenia is treatment-refractory in about one-third of patients. One way to combat this disparity is to improve medication development and discovery for psychiatric disorders through evidence-based research. Recently, most psychiatric medications approved by the United States Food and Drug Administration (FDA) are for increased tolerability or extended release. Because of the slow, incremental progress, there is a pressing need to explore novel medications with new indications or mechanisms of action to treat the expanding population with mental disorders, especially in those who are fully or partially recalcitrant to first-line medication options. This review aims to present the newest FDA medications with new indications, establish the clinical need for each, and discuss future directions in drug development. We searched and reviewed novel psychiatric medications approved by the FDA from 2018 to 2022. We then analyzed each medication in the United States Clinical Trials Registry and gathered updated results for efficacy and safety information. We also searched PubMed/MEDLINE (Medical Literature Analysis and Retrieval System Online), Scopus, Web of Science, Elsevier, and Google Scholar to understand how these new indications met current clinical needs. Finally, we inquired about related technological implications that will lead the field of psychopharmacology now and in the years to come. We found 12 novel psychiatric medications approved by the FDA from 2018 to 2022, representing a very small percentage of the total FDA approvals during that period. These psychiatric medications with novel mechanisms or improved efficacy and safety are expected to provide further options for treating mental health disorders; promising results will lead to new patterns of research.

Keywords: bremelanotide; brexanolone; lofexidine; pitolisant; solriamfetol.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Pharmaceutical agents approved by FDA in 2018-2022, segregated by specialty
OBGYN: obstetrics and gynecology Image credit: Shannon Giliberto

References

    1. The diminished pipeline for medications to treat mental health and substance use disorders. O'Brien PL, Thomas CP, Hodgkin D, Levit KR, Mark TL. Psychiatr Serv. 2014;65:1433–1438. - PMC - PubMed
    1. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022;9:137–150. - PMC - PubMed
    1. Ethical challenges in developing drugs for psychiatric disorders. Carrier F, Banayan D, Boley R, Karnik N. Prog Neurobiol. 2017;152:58–69. - PubMed
    1. Treatment resistance in psychiatry: state of the art and new directions. Howes OD, Thase ME, Pillinger T. Mol Psychiatry. 2022;27:58–72. - PMC - PubMed
    1. The BioPharmaceutical Pipeline: Evolving Science, Hope for Patients. Washington, D.C: PhRMA; 2013. PhRMA. The BioPharmaceutical Pipeline: Evolving Science, Hope for Patients.

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