FDA CRL - Ferring Pharmaceuticals Inc

The FDA issued a Complete Response Letter (CRL) to Ferring Pharmaceuticals Inc. on January 30, 2015, for its New Drug Application (NDA 022517) for Nocdurna (desmopressin) Orally Disintegrating Tablets. This CRL followed a previous action letter from January 30, 2013, and Ferring's subsequent complete response on July 31, 2014. The FDA determined that the application, reviewed under section 505(b) of the Federal Food, Drug, and Cosmetic Act, could not be approved in its current form. The main issues centered on insufficient clinical evidence that Nocdurna provides a meaningful benefit in reducing nocturnal voids that outweighs the associated risks of hyponatremia. This was a key discussion point during an advisory committee meeting on January 12, 2015. To address these deficiencies, Ferring must conduct a new clinical trial demonstrating meaningful patient benefit, utilizing validated patient-reported outcomes. The company is also required to prospectively evaluate and propose strategies for monitoring and mitigating hyponatremia risks for postmarketing use. Further required actions include providing a comprehensive safety update, revising the prescribing information, and resubmitting the proprietary name Nocdurna. All identified deficiencies must be fully addressed for the application to be reconsidered.