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The product, which received FDA approval in March 2023, was approved based on data from the randomized, double-blind, placebo-controlled phase 3 LAVENDER study (ClinicalTrials. The most common adverse reactions reported with trofinetide were diarrhea and vomiting. The most common adverse reactions reported with trofinetide led to statistically significant improvements on the Rett Syndrome Behaviour Questionnaire cardizem for arrhythmias total score and the Clinical Global Impression-Improvement score at week 12 compared with placebo (coprimary endpoints). The dosage is determined by patient weight and can be administered orally or via gastrostomy tube.

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