EMA Endorses Two ADHD Treatments for Children

Two treatments for children with attention-deficit hyperactivity disorder (ADHD) have been recommended by the European Medicines Agency (EMA) to receive marketing authorizations.

Paxneury for ADHD Symptoms

The agency’s Committee for Medicinal Products for Human Use (CHMP) said it was satisfied that Paxneury (guanfacine) reduces behavioral symptoms of ADHD such as hyperactivity, impulsivity, short attention span, and distractibility.

The drug contains guanfacine, a selective alpha-2A adrenergic receptor agonist. It modulates brain signaling pathways believed to contribute to ADHD symptoms.

Paxneury will be available as prolonged-release tablets at strengths ranging from 1 mg to 7 mg. It contains the same active substance as Intuniv but is available at higher strengths. The EMA confirmed the drug’s satisfactory quality and bioequivalence to Intuniv.

The most serious side effects associated with Paxneury are hypotension, weight gain, bradycardia, and syncope. Common side effects are somnolence, headache, fatigue, abdominal pain, and sedation.

Tuzulby Modified-Release Tablets

The CHMP also recommended a pediatric marketing authorization for Tuzulby, a modified-release chewable tablet for ADHD symptoms. Tuzulby’s active ingredient, methylphenidate hydrochloride, inhibits dopamine reuptake without stimulating dopamine release.

The EMA said that Tuzulby’s benefits are comparable to that of the reference medicine Ritalin, which contains the same active substance. However, Tuzulby is available in a different formulation and strength, designed for once-daily dosing to improve attention and behavior throughout the day.

Tuzulby will be available as 20 mg, 30 mg, and 40 mg tablets. Treatment must be started under the supervision of a specialist in childhood or adolescent behavioral disorders, the committee advised

Marketing authorizations recommended by the EMA are subject to approval by the European Commission.

Peter Russell has been a journalist for 40 years covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the UK.