Xanomeline/trospium combo outperforms standalone schizophrenia treatment, a possible psychosis-hypercortisolism connection, and maybe a better way to treat PTSD.

New Drug Combo for Schizophrenia-Related Agitation Outperforms

The U.S. Food and Drug Administration (FDA) has given the nod to xanomeline/trospium for the treatment of schizophrenia-related agitation. This combination of a muscarinic receptor agonist and a peripheral muscarinic antagonist appeared to boost tolerability compared to xanomeline alone.

The approval arrives in the wake of a trio of critical clinical trials (EMERGENT-1, EMERGENT-2, and EMERGENT-3), all of which revealed notable improvements in agitation and psychotic symptoms in schizophrenia patients.

Xanomeline/trospium outperformed the placebo in reducing agitation, based on the PANSS-EC scale, which tracks symptoms such as excitement and hostility.

The drug displayed a consistent benefit from the second week on. And it persisted through the five-week duration of each trial. In the pooled analysis of all three trials, participants treated with xanomeline/trospium boasted a 45.9% response rate – compared to 26.2% for those taking the placebo.

Safety analyses confirmed that participants tolerated xanomeline/trospium well, and endured fewer side effects than the ones that traditional antipsychotic drugs generate. Most of the documented adverse effects – such as nausea and constipation – appeared to be mild or moderate. This drug’s unique action on muscarinic receptors, rather than dopamine receptors, might offer an alternative for patients who struggle with the common side effects of traditional antipsychotics.

Although the xanomeline/trospium combination holds promise for managing agitation in schizophrenia patients, the researchers insist that additional studies would be necessary to affirm its long-term efficacy and safety, especially for higher-risk patients prone to violent behavior.

IN OTHER PSYCHIATRY AND NEUROLOGY NEWS

  • A case study in The Primary Care Companion for CNS Disorders highlights a 72-year-old man with no prior psychiatric history, who was diagnosed with new-onset psychosis due to hypercortisolism.
  • The Journal of Clinical Psychiatry reports that integrating psychotherapies and pharmacotherapies might address PTSD more effectively than monotherapies.
  • New data in PCC links late-pregnancy anxiety to perceived social support, while specific pregnancy-related anxiety themes correlated with distinct perceived social support domains.
  • Half a dozen psychiatric groups have issued a statement defending the use of psychotropics.
  • And the most recent installment in our “Emerging Approaches in Schizophrenia” series.