The new approval by the FDA increases the patient population which can be treated with the drug which is already approved for the treatment of adults with gastroesophageal reflux disease (GERD).
The safety of Nexium in adolescents ages 12 to 17 was evaluated in a multicenter, randomized, double-blind parallel group study in which a total of 149 patients, ages 12 to 17, with clinically diagnosed GERD were treated with either Nexium 20mg or Nexium 40mg once daily for up to eight weeks.
The most frequently reported treatment related adverse events were headache, abdominal pain, diarrhea and nausea, but no safety concerns were identified.
“GERD isn’t just a disease that affects adults, it also is common in childhood and can be problematic for adolescents as well,” said Dr Marta Illueca, director of medical science, GI respiratory, AstraZeneca. “We believe today’s approval is an important step in providing a valuable treatment option for thousands of patients across the country.”