The first and only transdermal patch for the treatment of adults with schizophrenia shows positive phase 3 trial results.
Noven Pharmaceuticals announced results1 from a pivotal, phase 3 trial, which showed that their asenapine transdermal system, SECUADO®, demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia. The first and only one of its kind, SECUADO is a transdermal patch intended for the treatment of adults with schizophrenia. The data are published in the January/February 2021 volume of The Journal of Clinical Psychiatry.
“Asenapine is a well-established treatment option and delivering it transdermally with SECUADO provides a non-intrusive approach and visual confirmation of adherence,” Leslie Citrome, MD, MPH, clinical professor of Psychiatry and Behavioral Sciences at New York Medical College, said to the press.2
The trial included participants aged 18 years or older who had acute cases of schizophrenia. Participants were randomized to either placebo, SECUDADO 7.6 mg per 24 hours, or SECUDADO 3.8 mg per 24 hours. SECUDADO achieved significant improvement in the PANSS total score by Week 6. Both the 7.6 and 3.8 SECUDADO groups showed differences in the least squares mean from baseline to Week 6, compared to placebo.
“Noven is pleased to offer a transdermal treatment option and is committed to assisting patients and caregivers with resources, including access to support specialists, through our Noven Care Access Network,” Joel Lippman, MD, Chief Operating Officer and Chief Medical Officer at Noven Pharmaceuticals, said to the press.2
The most common adverse reactions were extrapyramidal disorder, application site reaction, and weight gain. Incidence of application site related treatment-emergent adverse events was higher for SECUADO (14.2% for the 7.6 mg/24h group; 15.2% for the 3.8 mg/24h group) versus placebo (4.4%).
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1. Citrome L, Walling DP, Zeni CM, Starling BR, et al. Efficacy and safety of HP-3070, an asenapine transdermal system, in patients with schizophrenia: a phase 3, randomized, placebo-controlled study. J Clin Psychiatry. 2021;82(1).
2. Noven Pharmaceuticals, Inc. Results from Pivotal, Phase 3 Trial for SECUADO® (asenapine) Published in Journal of Clinical Psychiatry. News release. Businesswire. https://www.businesswire.com/news/home/20201215006070/en/Results-from-Pivotal-Phase-3-Trial-for-SECUADO®-asenapine-Published-in-Journal-of-Clinical-Psychiatry