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# Apricus Bio Plans Vitaros NDA Resubmission in 2017
- URL: https://www.fdaweb.com/apricus-bio-plans-vitaros-nda-resubmission-in-2017/
- Published: 2016-11-18T12:00:00.000Z
- Updated: 2026-09-14T21:49:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137382

Apricus Biosciences says it has received FDA feedback that supported the company’s strategy for addressing deficiencies contained in the 2008 Complete Response Letter on its Vitaros (alprostadil topical cream) NDA for treating erectile dysfunction. “Based upon our expert panel’s review of the FDA’s feedback, and the available Vitaros clinical and non-clinical data used to obtain regulatory approvals outside of the U.S., the company believes that there is a viable regulatory pathway for resubmission of the Vitaros NDA in the U.S. and, as such, we intend to re-submit the NDA as soon as possible in 2017,” it says.

Specifically, Apricus says FDA provided “clarity on the requirements” needed to address the deficiencies in the 2008 letter that included suggested additional analysis of existing clinical and non-clinical data. The feedback did not indicate that new clinical studies would be required for re-submission. Importantly, it says, the agency determined that Vitaros, under current regulations, is now considered a drug-device combination and, as such, Apricus was advised to meet with the Office of Product Quality to confirm the necessary device engineering and compliance requirements for the NDA resubmission. 

  
Vitaros contains alprostadil plus a novel excipient. The product delivers rapid onset (generally five to 30 minutes) and treatment duration of about one to two hours, according to the company. Vitaros is intended to provide a first line alternative to oral treatment.