FDA Approves Daily Asenapine Patch

In October the Food and Drug Administration (FDA) approved Secuado—a once-daily skin patch containing the antipsychotic asenapine—for the treatment of adults with schizophrenia. This approval marks the first transdermal formulation of an antipsychotic medication in the United States. Secuado is manufactured by Noven Pharmaceuticals.

According to Noven, the efficacy and tolerability of Secuado was demonstrated in a six-week randomized, placebo-controlled study involving 616 adults with schizophrenia. The study found that both low-dose and high-dose patches (3.8 mg over 24 hours and 7.6 mg over 24 hours) were superior to placebo at improving schizophrenia symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS). After six weeks, patients in the groups that received low and high transdermal doses of asenapine experienced an average drop in PANSS scores of 22 and 20 points, respectively, compared with an average drop in PANSS score of 15 points in those who received the placebo patch. Patients who received transdermal asenapine also had greater reductions in the overall severity of their illness, as assessed with the Clinical Global Impression-Severity (CGI-S) scale compared with those who received placebo.

The patches were well tolerated, with the most common side effects being extrapyramidal symptoms, skin reactions around the application site, and weight gain.

“The optimal antipsychotic treatment is one that provides low-dose efficacy with minimal side effects and addresses the issues surrounding poor compliance among patients with schizophrenia,” Leslie Citrome, M.D., a clinical professor of psychiatry and behavioral sciences at New York Medical College, stated in a recent commentary published in the Journal of Clinical Psychiatry. Citrome was an investigator on the Secuado trial and has received consulting fees from Noven. “[T]he development of novel transdermal treatments has the potential to fill some of these unmet needs.”

Specifically, transdermal patches can provide a more consistent flow of medication at lower concentrations than can be achieved with pills, since potential metabolism in the gastrointestinal (GI) system is bypassed; this mode of delivery also leads to fewer GI-related side effects such as constipation, nausea, and vomiting. Though asenapine is available as an orally dissolving tablet (which is taken into the bloodstream, also bypassing the stomach), the sublingual formulation is known to produce unpleasant sensations in the mouth (numbness or tingling). If the sublingual formulation is swallowed early, the medication is broken down in the stomach and loses its effectiveness.

“Asenapine is a well-tolerated second-generation antipsychotic drug that also has a good efficacy profile,” said Stephen Marder, M.D., a professor of psychiatry at the University of California, Los Angeles, and director of the Section on Psychosis at UCLA’s Semel Institute for Neuroscience and Human Behavior. “I could see this transdermal application used in many settings.”

Hospitals are one place where highly visible skin patches could help staff monitor treatment adherence, noted Marder, who was not involved in the development of Secuado. Such patches would likely not be useful in emergency situations, he continued, as the sustained release over 24 hours would be too slow in cases where patients become acutely agitated.

Even with a once-daily application, medication adherence can still be a concern, as symptoms can worsen if more than 24 hours has elapsed between applications. “It would be even better if the patch lasted more than 24 hours,” said Marder, noting that a long-acting transdermal application would be a noninvasive alternative to long-acting antipsychotic injections.

Aequus Pharmaceuticals is now testing a seven-day aripiprazole patch. ■