Oct 19, 2019
Officials from the FDA have approved Noven Pharmaceuticals, Inc.’s asenapine (Secuado) transdermal system, which is the first-and-only transdermal patch for the treatment of adults with schizophrenia, according to the company.

Asenapine is a once-daily, transdermal drug delivery system that is indicated to help mitigate some of the challenges patients face with the management of their schizophrenia. The patch provides sustained concentrations during the suggested wear time of 24 hours.

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.” [emphasis added]

Psych Congress Presentation Coverage:

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. Asenapine, a second-generation antipsychotic that is marketed in a sublingual form, was studied in a transdermal system (HP-3070) in a double-blind study of hospitalized schizophrenia patients. 

Leslie Citrome, MD, MPH, of New York Medical College in Valhalla, and colleagues reported results from 485 patients who completed the trial. Two doses — the low dose was the equivalent of 5 mg bid sublingual and the high dose was the equivalent of 10 mg bid sublingual — were compared to placebo. The primary efficacy endpoint was change in PANSS score from baseline. 

Both doses demonstrated efficacy against placebo (<0.05) — the benefit observed for the low dose beginning at week 2 and at weeks 3, 5, and 6 for the high dose. Both doses were well tolerated. If approved, HP-3079 would be the first transdermal antipsychotic available in the U.S. It is being developed by Noven Pharmaceuticals.