Adlon’s ADHD treatment approved but with black box warning

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Professor25)
(Image: Getty/Professor25)

Related tags: CNS, Fda, ADHD, Drug delivery, Drug delivery systems

Adlon announces FDA approval of its extended-release ADHD medication.

The US Food and Drug Administration (FDA) approval for Aldon Therapeutic’s’ Adhansia XR (methylphenidate hydrochloride) extended-release capsules comes with a black box warning against possible risks associated with the drug. 

Methylphenidate, the active ingredient in Adhansia XR, is a prescription stimulant and a federally controlled substance with a high potential for abuse and dependence.

A spokesperson for Purdue Pharma subsidiary, Adlon, told us that Methylphenidate is a commonly used central nervous system (CNS) stimulant for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The stimulant increases levels of norepinephrine and dopamine in the brain, however, the spokesperson continued by stating that the exact mode of therapeutic action of the ingredient in ADHD is not known.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Adhansia XR capsules contain multi-layered beads, which are composed of an immediate-release layer which contains approximately 20% of the stimulant dose, as well as a controlled-release layer which contains around 80% of the methylphenidate dose.

This drug delivery technology, known as multi-layer release (MLR) technology is a patented system by Purdue Pharma.

Related topics: Regulatory & Safety

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