FDA approves first and only transdermal patch for schizophrenia
pharmafile | October 16, 2019 | News story | Research and Development, Sales and Marketing | FDA, Noven Pharma, Secuado, US, pharma, schizophrenia
Hisamitsu Pharmaceutical subsidiary Noven Pharmaceuticals has revealed the FDA approval of Secuado (asenapine) in adult schizophrenia patients, making it the first and only transdermal patch formulation available in the US for the treatment of the condition.
Applied daily, the patch delivers the atypical antipsychotic asenapine. Phase 3 trial results indicated that Secuado generated a “statistically significant improvement” in change from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks of treatment compared to placebo, meeting the trial’s primary endpoint.
The therapy also showed a similar improvement according to the Clinical Global Impression-Severity (CGI-S) scale, achieving its key secondary endpoint.
“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Dr Leslie Citrome, Clinical Professor of Psychiatry and Behavioral Sciences at the New York Medical College. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilised.”
Dr Naruhito Higo, Chairman and Chief Executive Officer at Noven Pharma, also remarked: “There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms. We commend the FDA on the approval of Secuado and look forward to bringing it to market in the US as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”
Matt Fellows
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