Hisamitsu Pharmaceutical wholly-owned subsidiary Noven Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Secuado (asenapine) transdermal system to treat adults with schizophrenia.

Secuado is claimed to be the first-and-only transdermal patch formulation to treat adults with schizophrenia, which is a severe, chronic psychiatric disease with a heterogeneous course and symptom profile.

Secuado transdermal drug delivery system for adults with schizophrenia

The once-daily transdermal drug delivery system (TDDS) has been designed to offer sustained concentrations during wear time of the atypical antipsychotic drug asenapine, a treatment for schizophrenia.

Secuado is a prescription medicine developed for the treatment of schizophrenia, a severe and chronic psychiatric disease with a heterogeneous course and symptom profile.

Secuado met the primary endpoint of statistically significant improvement from baseline in the change of the total positive and negative syndrome scale (PANSS) compared to placebo at week six in the global phase 3 double-blind and placebo-controlled study.

The company evaluated the efficacy and safety of Secuado during the six-week treatment period in 616 adults living with schizophrenia.

Secuado also showed statistically significant improvement in clinical global impression-severity (CGI-S) scores, the key secondary endpoint of the phase 3 study.

Noven Pharmaceuticals chairman and CEO Dr Naruhito Higo said: “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 U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”

In July this year, AptarGroup secured FDA approval for its Unidose Powder System, which is the company’s first combination of a drug delivery device with a protective active packaging container.