The U.S. Food and Drug Administration (FDA) has approved Caplyta (lumateperone), a drug developed by Intra-Celullar Therapies Inc.
This new drug, which Intra-Celullar expects to launch late first quarter of 2020, could be transformative for individuals with schizophrenia, for one because in trials Caplyta didn't cause the side effect "akathisia," which Intra-Celullar said makes patients "jump out of their skin." With the elimination of that negative side effect, Caplyta could provide a meaningful contribution to schizophrenia treatment.
Effecting around 2.4 million adults in the U.S., schizophrenia can cause delusions, paranoia, and hallucinations.
"Schizophrenia is a complex disease that severely impacts patients and their families," said Jeffrey A. Lieberman, M.D., Director of the New York State Psychiatric Institute and Professor and Chairman of Psychiatry at Columbia University. "Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of CAPLYTA, approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia."
Intra-Celullar isn't alone in the market when it comes to developing new treatments for mental illnesses, though the area hasn't been particularly popular lately due to the field's inherent difficulty and apparent failure rate in drug testing.
"Many pharmaceutical companies have exited psychiatry in recent years because of high failure rates in clinical trials, only rudimentary understanding of disease mechanisms, and the lack of treatment biomarkers." That's according to a 2014 op-ed in Science magazine written by Steven Hyman, director of the Stanley Center for Psychiatric Research at the Broad Institute.
But that trend may be slowly changing.
The first treatment for postpartum depression was approved by the FDA in March 2019: Zulresso, a drug manufactured by Sage Therapeutics Inc.
Intra-Celullar has also been testing Caplyta for efficacy as a treatment for bipolar disorder.
- https://www.globenewswire.com/news-release/2019/12/23/1963993/0/en/FDA-Approves-Intra-Cellular-Therapies-Novel-Antipsychotic-CAPLYTA-lumateperone-for-the-Treatment-of-Schizophrenia-in-Adults.html
- https://br.reuters.com/article/idUSKBN1YR16H
- https://www.marketwatch.com/story/investors-flock-to-psychiatric-treatments-after-fda-approves-new-schizophrenia-drug-2019-12-23
- https://www.nami.org/NAMI/media/NAMI-Media/Research/Time-for-New-Schizophrenia-Rx_Hyman_2014.pdf
