Introduction and listing status of dextroamphetamine transdermal patch

Dextroamphetamine Transdermal System is a drug used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. As a stimulant, dextroamphetamine belongs to the phenylethylamine class of drugs. It mainly improves patients' attention, impulse control and self-regulation by increasing the release of dopamine and norepinephrine in the central nervous system. Its transdermal patch form makes the drug release more stable and sustained, avoiding the common blood concentration fluctuations of oral drugs, thereby providing a smoother therapeutic effect.

The mechanism of action of the dextroamphetamine transdermal patch is similar to that of traditional oral amphetamine, which relieves ADHD symptoms by activating the neurotransmitter system in the brain. Transdermal patches have fewer gastrointestinal side effects. At the same time, the drug can be absorbed directly through the skin and continuously releases the drug into the body. It is usually replaced every 24 hours to maintain the continued effectiveness of the drug.

This drug was first approved by the U.S. FDA for the treatment of ADHD and has been marketed in the United States and many other countries. Although oral dosage forms were initially used, the emergence of transdermal patches has provided a new treatment option for patients who cannot tolerate the side effects of oral medications. With the increasing global demand for ADHD treatment, dextroamphetamine transdermal patches have gradually been approved for marketing in more countries and are widely used.

However, despite the drug's good efficacy and low gastrointestinal upset profile, it is still a controlled substance, meaning its sale and prescription are strictly regulated. In some countries and regions, patients require a doctor's prescription to purchase and may require periodic medical evaluation. Because transdermal patch forms of the drug are used differently, approval times and scope of use may differ in some regions.

References: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf