Asenapine patch efficacious, safe for adults with schizophrenia

An asenapine transdermal system appeared effective for treating schizophrenia, according to results of a phase 3, randomized, placebo-controlled study published in Journal of Clinical Psychiatry.

“Asenapine, a second-generation antipsychotic, was initially available only as a twice-daily sublingual tablet,” Leslie Citrome, MD, MPH, of the department of psychiatry and behavioral sciences at New York Medical College, and colleagues wrote. “Complex dosing instructions and reported undesirable adverse effects, including dysgeusia, oral hypoesthesia and oral ulcers or blisters can make adherence to sublingual asenapine challenging. Transdermal administration of asenapine may address several unmet needs in patients with schizophrenia, including improved adherence by reducing dosing frequency to once daily.”

The investigators sought to determine the safety and efficacy of HP-3070, an asenapine transdermal system, among adults with acutely exacerbated schizophrenia according to DSM-5 criteria. They randomly assigned 204 participants to HP-3070 7.6 mg per day, 204 participants to HP-3070 3.8 mg per day and 206 participants to placebo. Change from baseline in week 6 Positive and Negative Syndrome Scale (PANSS) total score vs. placebo served as the primary endpoint and change from baseline in week 6 Clinical Global Impression-Severity of Illness score vs. placebo served as the key secondary endpoint. Treatment-emergent adverse events and dermal assessments were safety endpoints.

Results showed significant improvement associated with each of the HP-3070 doses vs. placebo at week 6 for the primary and key secondary endpoints. Least-squares mean differences of change from baseline in PANSS total scores were 4.8 and 6.6 for the higher and lower doses, respectively. The researchers noted that HP-3070 was well tolerated and had a systemic safety profile consistent with sublingual asenapine. HP-3070 had higher incidence of application site treatment-emergent adverse events vs. placebo. Discontinuations associated with skin disorders or application site reactions were infrequent.

“Given the known unmet needs in the treatment of schizophrenia, patients, caregivers and health care providers are in search of new treatment options that can be individually optimized for patient use,” Citrome and colleagues wrote. “As the first and only transdermal antipsychotic available in the United States, HP-3070 provides a novel and potentially preferred treatment formulation for individuals with schizophrenia.”