FDA News

FDA approves asenapine transdermal patch for schizophrenia

The FDA has approved the first asenapine transdermal system for the treatment of adults with schizophrenia, according to a press release from the agent’s manufacturer.

The once-daily patch formulation delivers asenapine (Secuado, Noven Pharmaceuticals) over a sustained 24-hour wear time.

“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,” Naruhito Higo, PhD, chairman and CEO of Noven Pharmaceuticals, said in the release.

In a commentary published in Journal of Clinical Psychiatry, Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences at New York Medical College, and colleagues noted the potential benefits of transdermal treatment for patients with psychiatric illnesses, including reduced dosing frequency, effective control of plasma medication concentrations, improved tolerability, ability to check compliance visually and avoidance of first-pass hepatic metabolism.

“As people living with schizophrenia cycle through treatments, their therapeutic options narrow,” Citrome said in the release. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and health care providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

Results from a phase 3 trial presented at Psych Congress showed that among 616 adults with schizophrenia, asenapine reached the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale compared with placebo at 6 weeks. It also demonstrated statistically significant improvement in the Clinical Global Impression-Severity scores.

According to the release, adverse reactions included extrapyramidal disorder, application site reaction and weight gain. Overall, the systemic safety profile of asenapine was consistent with that of sublingual asenapine.

“We commend the FDA on the approval of Secuado and look forward to bringing it to market in the United States as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment,” Higo said.

References:

BioSpace. U.S. FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia. https://www.biospace.com/article/releases/u-s-fda-approves-secuado-asenapine-transdermal-system-the-first-and-only-transdermal-patch-for-the-treatment-of-adults-with-schizophrenia/. Accessed Oct. 16, 2019.

Citrome L, et al. J Clin Psychiatry. 2019;doi:10.4088/JCP.18nr12554.

Disclosures: Citrome reports several ties to industry, including consulting fees from Noven Pharmaceuticals. Please see the commentary for all of Citrome’s and the other authors’ relevant financial disclosures.

The FDA has approved the first asenapine transdermal system for the treatment of adults with schizophrenia, according to a press release from the agent’s manufacturer.

The once-daily patch formulation delivers asenapine (Secuado, Noven Pharmaceuticals) over a sustained 24-hour wear time.

“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,” Naruhito Higo, PhD, chairman and CEO of Noven Pharmaceuticals, said in the release.

In a commentary published in Journal of Clinical Psychiatry, Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences at New York Medical College, and colleagues noted the potential benefits of transdermal treatment for patients with psychiatric illnesses, including reduced dosing frequency, effective control of plasma medication concentrations, improved tolerability, ability to check compliance visually and avoidance of first-pass hepatic metabolism.

“As people living with schizophrenia cycle through treatments, their therapeutic options narrow,” Citrome said in the release. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and health care providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

Results from a phase 3 trial presented at Psych Congress showed that among 616 adults with schizophrenia, asenapine reached the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale compared with placebo at 6 weeks. It also demonstrated statistically significant improvement in the Clinical Global Impression-Severity scores.

According to the release, adverse reactions included extrapyramidal disorder, application site reaction and weight gain. Overall, the systemic safety profile of asenapine was consistent with that of sublingual asenapine.

“We commend the FDA on the approval of Secuado and look forward to bringing it to market in the United States as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment,” Higo said.

References:

BioSpace. U.S. FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia. https://www.biospace.com/article/releases/u-s-fda-approves-secuado-asenapine-transdermal-system-the-first-and-only-transdermal-patch-for-the-treatment-of-adults-with-schizophrenia/. Accessed Oct. 16, 2019.

Citrome L, et al. J Clin Psychiatry. 2019;doi:10.4088/JCP.18nr12554.

Disclosures: Citrome reports several ties to industry, including consulting fees from Noven Pharmaceuticals. Please see the commentary for all of Citrome’s and the other authors’ relevant financial disclosures.