FDA eyes 1st schizophrenia drug in decades: 5 things to know

 The FDA is set to make a pivotal decision Sept. 26 about KarXT, a novel antipsychotic developed by Karuna Therapeutics. If approved, it would be the first drug with a unique mechanism for treating schizophrenia in decades, Medscape reported Sept. 20. 

Here are five things to know: 

1. KarXT is a coformulation of xanomeline and trospium chloride, designed to selectively activate muscarinic receptors in the brain, unlike traditional antipsychotics that primarily target dopamine receptors. 
   
   
2. The safety and effectiveness of the drug was assessed in phase 3 trials, which showed KarXT had a 9.6 point reduction in positive and negative syndrome scale scores compared to the placebo, according to Medscape. 
   
   
3. The drug demonstrated a favorable side-effect profile, with no weight gain or extrapyramidal symptoms reported, common issues with existing treatments. However, other symptoms that were reported by patients included constipation and gastrointestinal discomfort. 
   
   
4. KarXT's mechanism could provide new hope for diverse patient populations, including those who have not responded well to traditional antipsychotic medications in the past and could help improve overall quality of life. 
   
   
5. While the initial trial data for the drug is promising, experts caution that long-term efficacy and effects in broader patient populations remain uncertain. If approved, KarXT could become available by late October. 

https://www.beckershospitalreview.com/pharmacy/fda-eyes-1st-schizophrenia-drug-in-decades-5-things-to-know.html