United States: The US FDA, on Thursday, green-lighted an important new medication for schizophrenia, which is the first special advancement in decades.
More about the New Drug
Cobenfy (xanomeline/trospium chloride) offers hope to patients seeking relief from hallucinations and intrusive voices that disrupt their lives, all without the weight gain and sluggishness associated with traditional dopamine-focused treatments.
While Cobenfy does impact dopamine, it does so indirectly by targeting cholinergic receptors, which in turn modifies the activity of acetylcholine, another neurotransmitter, US News reported.
What are the experts stating?
Dr. Tiffany Farchione, the director of psychiatry in the Office of Neuroscience, added. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed,”
The FDA said that schizophrenia is in about one percent of the population and involves marked by intrusive thoughts, hallucinations (including auditory experiences), and paranoia, all of which can severely disrupt daily functioning and social interactions.
The illness can be debilitating and significantly increases the risk of early mortality; nearly 5 percent of individuals with schizophrenia die by suicide, as noted by the FDA.
Most of the current medications perform by blocking dopamine receptors in the brain to help manage symptoms. However, they are also associated with certain side-effects such as weight gain, lethargy.
About the drug tests
Developed by Bristol Myers Squibb, Cobenfy was evaluated in two “double-blind” five-week trials, ensuring that neither patients nor those administering the drug knew whether they were receiving Cobenfy or a placebo.
Patient outcomes were assessed using a standard 30-item scale for schizophrenia symptoms.
According to the FDA, “In both studies, the participants who received Cobenfy experienced a meaningful reduction in symptoms from baseline to Week 5,” US News reported.
There are certain negative side of the drug, and gives issues related to gastrointestine such as nausea, indigestion, constipation, and vomiting, along with an increased heart rate and acid reflux.
Due to the risk of liver damage, Cobenfy is not recommended for individuals with pre-existing liver impairment.