Critical appraisal of selegiline transdermal system for major depressive disorder

ABSTRACT

Introduction: Although safer and easier to use antidepressants (ie.,SSRIs/SNRIs) have largely displaced MAOIs, these medications still have a role in difficult to treat conditions. Efforts to improve MAOIs benefit-risk profile resulted on the reversible MAOI and in the first antidepressant patch (selegiline transdermal delivery system-STS). The later had been available in the US since 2006. Thus a review on its safety profile and comparative efficacy is timely.

Areas covered: This review provides an overview of STS’s clinical pharmacology and summarizes what has been learned across nearly a decade of experience. Product labels and the search engine PubMed were used to obtain relevant information.

Expert opinion: STS remains a unique treatment option. It is the only FDA-approved antidepressant for patients with significant problems ingesting, tolerating, or absorbing oral medications. It remains the only MAOI that can be initiated without dietary restrictions at a therapeutic dose and has a low incidence of side effects when compared to other MAOIs. STS also provides an interesting option for depressed patients suffering from Parkinson’s disease. However these advantages are counterweighted by drawbacks including the need for wash-out periods and the lack of convincing data illustrating its utility for treatment of more severe, treatment refractory depression.

KEYWORDS:

• Selegiline
• Transdermal
• Depression
• Treatment

Article highlights

• Selegiline transdermal delivery system (STS) is the only US FDA-approved antidepressant available as a skin patch and the only pharmacological treatment option for patients unable to swallow, absorb, or tolerate oral formulations.

• STS provide 24 h of sustained therapy with selegiline at lower plasma concentrations, which translates into fewer side effects related to plasma-level fluctuations when compared to conventional divided dosing of oral monoamine oxidase inhibitors.

• Formal head-to-head studies versus other effective antidepressants are still needed to assess STS’s actual comparative antidepressant efficacy, especially for patients with more treatment-resistant-depressive episodes.

• Although the risk of hypertensive crisis during STS therapy is quite low even at higher doses, studies to corroborate or discredit the need for dietary precautions when using the 30 mg (9 mg/day) or 40 mg (12 mg/day) STS are unlikely to happen at this juncture. Until then, the standard preventive measures should be followed when prescribing this agent.

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Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.