What will the approval of a transdermal patch mean to patients with schizophrenia as well as psychiatrists looking for innovations in mental health care?
The US Food and Drug Administration has approved Secaudo (asenapine), a once-daily transdermal drug delivery system (TDDS), the first and only patch of its kind to treat adult schizophrenia.1 The drug is manufactured by Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co.
When asked what the approval will mean for psychiatrists looking for innovations in care to patients with schizophrenia, Leslie Citrome, MD, MPH, a consultant for Noven, noted that the asenapine transdermal patch “offers physicians and patients the option of choosing a proven and familiar transdermal delivery system to help control schizophrenia symptoms.” With the flexibility of choice, especially when patients prefer not to take pills, “it should be noted that other transdermal patch therapies, such as the nicotine patch, have been successful and are well-known.”
Because there is “an enormous need” for novel treatments, says Dr Citrome, Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College, patients whose symptoms are managed effectively are less likely to relapse, so adherence is critical for a meaningful life. “Adults with schizophrenia, people with schizophrenia who have a preference for a patch instead of an oral medication or injectables, and patients prescribed sublingual asenapine but find twice-daily dosing and bad taste bothersome are uniquely suited” for transdermal asenapine.
The new delivery method provides a noninvasive means to take medication and provides sustained concentrations during wear time. Early termination of the drug is achievable, if needed. However, it is not long acting, requiring daily dosing (change of patch).
According to Dr Citrome, the patch “may fulfill unmet needs in people with psychiatric illnesses through reduced dosing frequency, effective control of medication plasma concentrations, avoidance of first-pass hepatic metabolism and the potential to reduce tolerability issues such as oral hypoesthesia associated with a sublingual tablet.” Further, “a transdermal system avoids the restrictions on eating/drinking post sublingual administration.” Caregivers will be more able to ensure patients are adhering to treatment since administration is visually verifiable.
Oral versus transdermal
The most common drug delivery system is oral administration, but it has its challenges. “Even with this route of administration, significant rules may apply to obtain consistent and adequate serum levels. One common example is that of levothyroxine, which needs to be taken on an empty stomach. Other drugs may require the presence of a specific number of calories to maximize absorption, or a specific pH of the stomach,” said John J. Miller, MD,2 Editor in Chief of Psychiatric Times.
Although sublingual asenapine, an atypical antipsychotic, was approved to treat bipolar disorder and schizophrenia, it cannot be swallowed.3 Because of the lifelong and chronic nature of schizophrenia and difficulty to treat consistently over the long term, a transdermal drug delivery with asenapine, absorbed into the skin over a 24-hour period, has “has several innate advantages that have the potential to benefit various patient populations, including those with central nervous system disorders.”
In a Phase 3, double-blind, placebo-controlled study of 616 adults with schizophrenia, Citrome and colleagues4 found that transdermal asenapine “achieved 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. Efficacy and safety were assessed during the six-week treatment period" in study participants.
A press release announced that “Secuado demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase 3 study.”1 As far as safety, Secuado was consistent with what is known for sublingual asenapine, but adverse reactions were weight gain, extrapyramidal disorder, and reaction to the application site.5
Although asenapine has been found to be effective and safe in adult schizophrenia, the jury is out regarding its application in children younger than aged 18 years.
1. U.S. FDA Approves SECUADO® (asenapine) Transdermal System, the First-and-Only Transdermal Patch for the Treatment of Adults with Schizophrenia. Press release, October 15, 2019. https://www.businesswire.com/news/home/20191015005668/en/U.S.-FDA-Approves-SECUADO%C2%AE-asenapine-Transdermal-System. Accessed October 15, 2019.
2. Miller JJ. A Drug’s Journey: From the Pill Bottle to the Toilet. Psychiatric Times. 2019;36(9):11,18.
3. Citrome L, Zeni CM, Correll CU. Patches: Established and Emerging Transdermal Treatments in Psychiatry. J Clin Psychiatry. 2019;80(4).
4. Citrome L, Walling D, Zeni C, et al. Efficacy and safety of an asenapine transdermal patch (asenapine transdermal system, HP-3070) in the treatment of adults with schizophrenia: a phase 3 randomized, double- blind, placebo-controlled, 6-week, inpatient study [abstract]. Neuropsychopharmacology. 2018;43(suppl 1):S116–S117.
5. Secuado [prescribing information]. Miami, FL: Noven Therapeutics LLC; 2019. Prescribing information: http://www.noven.com/SECUADO_USPI.pdf.