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PT-141

Bremelanotide, Vyleesi

Quick Stats
Studies 74
Trials 10
2024 pubmed 4 citations

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

Giliberto. Shannon S; Shishodia. Rhea R; Nastruz. Meredith M; Brar. Chamandeep C; Bulathsinhala. Sadeepa S; Terry. Jonathan J; Pemminati. Sudhakar S; Shenoy. Sudhakar K SK

Key Findings

  • Only 12 novel psychiatric medications were approved from 2018‑2022, a tiny fraction of total FDA approvals.
  • Most new approvals focus on improved tolerability or extended‑release formulations rather than entirely new mechanisms.
  • The authors highlight a need for drugs with novel mechanisms to help patients who do not respond to existing treatments.

Practical Outcomes

  • For biohackers interested in PT‑141, this review provides no actionable information, dosage guidance, or safety data. The only indirect relevance is the broader call for novel mechanisms in drug development, which could inspire looking for similar innovative pathways in peptide research.

Summary

The paper reviews 12 new psychiatric drugs approved by the FDA between 2018 and 2022, focusing on their clinical need, safety, and how they might shape future psychopharmacology. It does not mention the peptide PT‑141 at all, so it offers no direct guidance for using that peptide.

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.

Study Information

Provider

pubmed

Year

2024

Date

2024-03-20T00:00:00.000Z

DOI

10.7759/cureus.56561

Citations

4

References

71