The Food and Drug Administration (FDA) has approved a new strength of Tracleer (bosentan; Actelion) tablet for oral suspension for use in children aged ≥3 years with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.

The new 32mg tablet for oral suspension marks the first FDA-approved drug for pediatric PAH. Prior to this, Tracleer was approved for the treatment of PAH (WHO Group I) in adult patients to improve exercise ability and decrease clinical worsening. 

The 32mg scored tablet can be dispersed in one teaspoon of water prior to oral administration. The lower dosage and scored design enables physicians to vary the prescribed dose according to patient weight. 

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Tracleer is an orally active endothelin receptor antagonist (ERA) at endothelin receptor types ETA and ETB. Endothelin-1 (ET1) is a neurohormone that is elevated in plasma and lung tissue of patients with PAH, suggesting a pathogenic role for ET-1 in this disease.

Tracleer is also available as 62.5mg and 125mg tablets for adult use. The 32mg tablets for oral suspension will be available in 56-count cartons or 14-count blister strips. The product is anticipated to launch by the 4th quarter of 2017.

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