Message: Reminder: Fifty years have lapsed since the last introduction of a new antipsychotic drug
In the realm of mental health research, it has been half a century since a new effective antipsychotic medication was introduced. This gap in treatment options is a pressing issue for half of the Americans with mental illness, who are not receiving any treatment at all. The shift in the US pharmaceutical industry's focus away from psychiatric drug research is concerning, especially given the urgent need for the development of effective, evidence-based psychiatric medications.
Florence Fee, the Executive Director of NHMH - No Health without Mental Health, based in Arlington, Virginia, US, is advocating for the development of such medications. The organization's mission is to address the unmet needs in serious mental illness treatment.
Recent advances include the submission of supplemental new drug applications to the FDA, based on robust clinical trial data. For instance, Johnson & Johnson submitted a supplemental application for CAPLYTA® (lumateperone) in July 2025. This new medication demonstrated a 63% reduction in schizophrenia relapse risk compared to placebo in long-term Phase 3 trials, enhancing treatment options available for adults with schizophrenia and bipolar depression.
While the search results did not provide specific recent figures on National Institute of Mental Health (NIMH) allocation, ongoing efforts and approvals suggest continued investment by public agencies like NIMH in clinical trials and drug development for psychiatric disorders. These agencies typically fund foundational research and early-phase clinical studies, working in partnership with pharmaceutical companies to translate findings into approved treatments.
The pharmaceutical industry plays a critical role in advancing antipsychotic medications. Companies like Johnson & Johnson maintain extensive portfolios of oral and injectable schizophrenia therapies and actively seek FDA approvals backed by rigorous clinical data. Industry involvement includes conducting large-scale trials, regulatory submissions, and expanding indications for existing drugs, highlighting both innovation and commercial engagement in this therapeutic area.
However, challenges remain in improving efficacy, tolerability, and relapse prevention. The post-Covid increase in the number of Americans with mental illness underscores the need for more resources and research in this area. The global need for effective, evidence-based psychiatric medications is also highlighted, as the number of individuals affected by serious mental illnesses continues to grow.
The US pharmaceutical industry has shifted its priority from psychiatric drug research to oncology medications in recent years, which is a cause for concern. The National Institute of Mental Health (NIMH) has had inadequate funding for its "services and intervention research" division, further exacerbating the situation.
In conclusion, the current U.S. landscape shows promising new treatments like CAPLYTA® reaching the FDA review stage supported by strong efficacy data. NIMH likely continues to support research and early development stages, although precise recent funding details were not found in the results. Pharmaceutical companies are driving late-stage development, approval processes, and expanding treatment options, exemplified by Johnson & Johnson’s recent FDA submissions. This combined effort aims to address ongoing unmet needs in serious mental illness treatment, though challenges remain in improving efficacy, tolerability, and relapse prevention.
For more detailed information on NIH/NIMH funding allocation or broader pharmaceutical industry trends, please specify for further targeted searches.
[1] Johnson & Johnson Press Release. (2025, July). Johnson & Johnson Announces Submission of Supplemental New Drug Application for CAPLYTA® (lumateperone) for the Maintenance Treatment of Schizophrenia. Retrieved from https://www.jnj.com/johnson-johnson-announces-submission-of-supplemental-new-drug-application-for-caplyta-lumateperone-for-the-maintenance-treatment-of-schizophrenia
[2] ClinicalTrials.gov. (n.d.). A Study of the Safety and Efficacy of Lumateperone (JNJ-37846633) in the Maintenance Treatment of Schizophrenia. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04694162
- The development of effective psychiatric medications continues to be a priority, as evidenced by Johnson & Johnson's submission of a supplemental application for CAPLYTA® (lumateperone) in the realm of health-and-wellness, specifically targeting mental health.
- Therapies-and-treatments, such as CAPLYTA®, are critical in the battle against serious mental illnesses, with their potential to improve efficacy, tolerability, and relapse prevention, making a significant impact on the lives of those affected.
