The FDA is poised to issue a decision soon on KarXT, a potential first-in-class antipsychotic for schizophrenia. What should you know about the drug's history…and promise?
The US Food and Drug Administration is due to issue a decision by September 26 on the approval of KarXT, a potential first-in-class antipsychotic. If approved, it would be the first drug with a novel mechanism to treat schizophrenia in decades.
First-generation antipsychotics, dating back to the 1950s, targeted the postsynaptic dopamine 2 receptor. Chlorpromazine, the first of that class, was approved by the FDA in 1954. That was followed by the development of numerous drugs with the same mechanism of action. However, the medications had significant side effects, especially neurologic ones such as parkinsonism.
"This activity occurs without any dopamine receptor blockade, which makes this approach distinct from the current standard of care, which rely on targeting dopamine and/or serotonin receptors," he added. Xanomeline and trospium were titrated from 50 mg/20 mg twice daily to 125 mg/30 mg twice daily, and patients were treated for a total of 5 weeks. Efficacy and safety analyses were conducted in those who had received at least one dose of the study drug., at the end of the treatment period, KarXT was associated with a significant 9.6-point reduction in Positive and Negative Syndrome Scale total scores relative to placebo. PANSS total scores fell by 21.2 points with KarXT vs 11.
"The long-term efficacy and side effects of KarXT in more clinically stable outpatients or in the real-world schizophrenia patient population are unclear," Fan said. "However, these trials do not include a control group. Studies with active control groups are needed to allow direct comparison of KarXT with other antipsychotics," Fan said.
Antipsychotics Neuroleptics Neuroleptic Drugs Atypical Antipsychotics Second Generation Antipsychotics Receptors Adverse Effects Side Effects Patient Safety Extrapyramidal Symptoms Extrapyramidal Side Effects Extrapyramidal Adverse Effects Dopamine
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
UTSA and UT Health merger is a game changer for San AntonioThe merger between UTSA and UT Health is all about academic excellence and opportunity.
Read more »
This 1 Unexpected Exercise Could Be A Game Changer If You Have Jaw PainKelsey Borresen is a senior reporter at HuffPost Life, covering love, sex and relationships. She is a graduate of the University of Southern California's Annenberg School for Communication and Journalism and lives in Los Angeles.
Read more »
Russia’s new fiber optic drone is immune to jamming, could be game-changer in warControlled by fiber optic cable, Russia's new drone is claimed to have high accuracy and resistance to electronic warfare.
Read more »
Russia’s new fiber-optic drone is immune to jamming, could be game-changer in warControlled by fiber optic cable, Russia's new drone is claimed to have high accuracy and resistance to electronic warfare.
Read more »
Eliminating These 3 Foods From Your Diet Can Be A Game-Changer For Heart HealthLeigh is a New York-based freelance journalist covering topics ranging from health and wellness to feminism and personal finance. Her work has been featured on Well+Good, mindbodygreen, HuffPost NBC News, Elite Daily, Bustle, and more.
Read more »
Deion Sanders unconventional approach will be a game changer for ColoradoPrime's Buffaloes are now less than a week away from the start of the 2024 season
Read more »