By Scott Baltic
NEW YORK—Use of a transdermal patch to administer the second-generation anti-psychotic blonanserin improves both positive and negative symptoms of acute schizophrenia with manageable adverse effects, a new industry study shows.
"These findings suggest that the once-daily transdermal patch formulation of blonanserin provides an effective and well-tolerated treatment option for patients with acute schizophrenia, and expands the options for patients to consider during schizophrenia management," researchers write in Schizophrenia Research, online August 27.
Their randomized, double-blind, placebo-controlled phase-3 trial was the first study to evaluate the efficacy and safety of the once-daily blonanserin transdermal patch in patients with acute schizophrenia, Dr. Yoshifumi Inoue of Sumitomo Dainippon Pharma Co. Ltd., in Tokyo, and colleagues write.
Blonanserin has not been approved by the U.S. Food and Drug Administration.
Poor adherence to antipsychotic medication is a consistent issue in managing schizophrenia, according to the authors. A patch, they suggest, could increase adherence, both because it can be hidden beneath clothing (removing the stigma of oral or injectable medications) and because it provides evidence to medical staff or caregivers of adherence.
The new multicenter study enrolled individuals ages 18 and older diagnosed with schizophrenia per DSM-5 criteria and an exacerbation of psychiatric symptoms less than two months before screening for study entry. Patients were hospitalized from the time of the screening until at least two weeks into the study.
The researchers randomly assigned 580 participants (59% male; mean age, 40; 85.5% Asian) to receive daily blonanserin 40 mg, 80 mg, or placebo for six weeks.
With specific exceptions, the use of other antipsychotic medication(s), or of antimanic, anticonvulsant, monoamine oxidase inhibitor, antiparkinsonian, psychotropic, or hypnotic drugs was prohibited during the study. By the end of the study, however, nearly three-quarters of participants had received such medications.
At the end of six weeks, 448 patients (77.2%) had completed the study. The drug improved total score on the Positive and Negative Symptom Scale significantly compared with placebo (least-squares mean difference, -5.6 with blonanserin 40 mg and -10.4 with blonanserin 80 mg).
The effect size with the blonanserin 80 mg patch, the authors write, "suggests that blonanserin may not be inferior to other drugs available for the treatment of schizophrenia."
Severe treatment-emergent adverse events (TEAEs) included akathisia (0.5% of patients on 80 mg blonanserin). But "incidence of serious TEAEs reported during the study was similar among the three groups and TEAEs requiring treatment discontinuation were reported in 17 (8.9%), 16 (8.2%), and 11 (5.7%) patients receiving placebo, blonanserin 40 mg, and 80 mg, respectively," the researchers say.
Extrapyramidal adverse events were reported in 7.9%, 10.7% and 20.6% of the participants in the placebo, blonanserin 40 mg, and 80 mg groups, respectively, but most of these were considered mild or moderate.
Skin-related adverse events at the sites of patch application were reported in 4.2%, 13.3%, and 18.6% of patients in the placebo, blonanserin 40 mg, and 80 mg groups, respectively, but none of these were considered severe.
Dr. Philip D. Harvey, director of the division of psychology at the University of Miami Miller School of Medicine, told Reuters Health by email, "Transdermal patches have been shown to be better for adherence in other conditions."
"They also bypass some gastrointestinal side effects," added Dr. Harvey, who was not involved in the study. "Patches are often also better for keeping medication levels stable over time."
Dr. Stephen R. Marder of the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles, said that daily application of the patch, as opposed to less often, makes this product "a little less desirable."
And the relatively high rate of skin reactions at the higher dose is a potentially important issue if the drug becomes widely used, he told Reuters Health by email.
Nonetheless, if the blonanserin patch were to be approved in the United States, concluded Dr. Marder, who was not involved in the research either, "I think it would have a niche."
Dr. Inoue did not respond to a request for comments.
Schizophr Res 2019.
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