Aliskiren Oral Pellets Now Approved for Treatment of Pediatric Hypertension

The FDA has approved aliskiren oral pellets for hypertension treatment.

The Food and Drug Administration (FDA) has approved Tekturna (aliskiren; Noden Pharma) Oral Pellets for the treatment of hypertension in adults and children at least 6 years of age. This expanded indication and new formulation provide an additional option for treating pediatric patients with hypertension.

The safety and efficacy of Tekturna for pediatric use was evaluated in an 8-week randomized, double-blind study in 267 hypertensive patients 6 to 17 years of age. During the initial dose-response phase, aliskiren reduced both systolic and diastolic blood pressure in a weight-based dose-dependent manner.  

Following the 8-week study, 208 patients were enrolled in a 52-week extension trial in which patients were randomly assigned to either aliskiren or enalapril. At the end of 52 weeks, reductions in blood pressure from baseline were similar in patients receiving aliskiren (7.6/3.9 mm Hg) and enalapril (7.9/4.9 mm Hg).

Tekturna Oral Pellets are provided in a dispensing capsule which should not be swallowed; the contents of the capsule should also not be emptied directly into the mouth. Instead, the capsules should be opened and the contents emptied into a spoon and then by mouth, followed with milk (dairy or soy-based) or water immediately without chewing or crushing. In addition, the contents of the dispensing capsule may be mixed with ≥1 teaspoon of vanilla pudding (milk or soy-based), vanilla ice cream (milk or soy-based), milk (dairy or soy-based), or water as a dosing vehicle. 

Tekturna 37.5mg Oral Pellets will be available as unit-dose blister packs (8 strips of 6 capsules) in 2018.

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Noden Pharma announces FDA approval of Tekturna® (aliskiren) oral pellets for the treatment of hypertension in adults and children 6 years of age or older [press release]. Dublin, Ireland: Noden Pharma DAC. Published November 14, 2017. Accessed November 29, 2017.

This article originally appeared on MPR