In the clinical trial section of the PI, all the trials are labeled with esomeprazole magnesium, which is Nexium®. Did your company perform trials with esomeprazole strontium?
The brand version of esomeprazole strontium was approved by the U.S. FDA as an NDA (New Drug Application) under section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act. A 505(b)(2) application allows for a certain degree of variation from an approved product (reference drug) while still relying on some of the data from the approved product. In addition to esomeprazole strontium pharmacokinetic/safety trials, the application relied upon the FDA's previous findings of safety and efficacy for Nexium®. Because of this reliance, data from the Nexium® clinical trials supporting the safety and efficacy of esomeprazole magnesium are contained within the full Prescribing Information (PI) for esomeprazole strontium.
Studies
Answers to Frequently Asked Questions
Please see the Full Prescribing Information and Important Safety Information for esomeprazole strontium.
Did Amneal ever do any clinical trials comparing the two to see which was better in terms of side effects or efficacy?
Amneal did not do any clinical trials comparing Esomeprazole Strontium and Nexium®. Clinical trials were conducted to demonstrate that Esomeprazole Strontium was pharmacokinetically (Cmax and AUC) comparable to esomeprazole magnesium delayed-release capsules. Esomeprazole Strontium was approved by the FDA based on the same adult efficacy and safety data as Nexium®, per the FDA-approved Full Prescribing Information for Esomeprazole Strontium.