Karuna Therapeutics Announces The Lancet Publication of Data from Phase 3 EMERGENT-2 Trial Evaluating KarXT in Schizophrenia
KarXT demonstrated statistically significant and clinically meaningful improvements in positive and negative symptoms of schizophrenia compared to placebo, as measured by primary and secondary endpoints
KarXT was generally well tolerated and not associated with many adverse events typically associated with current antipsychotics, including somnolence, weight gain and extrapyramidal symptoms
New Drug Application for KarXT for the treatment of schizophrenia in adults was recently accepted with a Prescription Drug User Fee Act (PDUFA) action date of
If approved, KarXT, a dual M1/M4 muscarinic agonist, would represent the first new pharmacological approach to treating schizophrenia in several decades
“Having such robust data showcased in one of the world’s most prestigious medical journals attests to the potential of KarXT’s novel mechanism of action to redefine the treatment landscape for the millions grappling with schizophrenia’s disabling symptoms,” said
The Phase 3 EMERGENT-2 trial was a double-blind, placebo-controlled, five-week inpatient trial that enrolled 252 adults with schizophrenia in
KarXT was generally well tolerated, with overall discontinuation rates similar to placebo (KarXT 25% vs. placebo 21%). Discontinuation rates due to treatment-emergent adverse events (TEAEs) were also similar between KarXT and placebo (7% vs. 6%, respectively). The most common KarXT TEAEs (≥5% and at least twice the rate of placebo) were constipation, dyspepsia, nausea, vomiting, hypertension, dizziness, and gastroesophageal reflux disease (acid reflux). The majority of common TEAEs occurred in the first two to three weeks of treatment, were transient, and resolved before the end of the trial (week 5). The data from EMERGENT-2 suggests that KarXT may have a distinctive safety and tolerability profile, as it was not associated with many of the adverse events typically associated with current antipsychotic treatments, including somnolence, weight gain and extrapyramidal motor symptoms.
“Coming off the heels of our NDA acceptance of KarXT for the treatment of schizophrenia, this publication in
“New treatments and novel mechanisms are urgently needed for people with schizophrenia because many don’t respond to their therapy and others only have a partial improvement in symptoms or intolerable side effects,” said
The published manuscript, titled “Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2): results from a randomized, double-blind, placebo-controlled, flexible-dose phase 3 trial in the United States,” is available online and will appear in the print issue of
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the
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