Apricus Biosciences (APRI) Updates on Type B Meeting with FDA for Vitaros CRL; No Additional Studies Needed

November 18, 2016 7:05 AM EST

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Apricus Biosciences, Inc. (Nasdaq: APRI) announced that it has received feedback in response to its previously announced Type B Meeting request to the U.S. Food and Drug Administration (FDA). The purpose of the FDA meeting request was to confirm Apricus’ strategy for addressing the deficiencies contained in the 2008 Complete Response letter. 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.

Specifically, the FDA provided clarity on the requirements needed to address the deficiencies in the 2008 Complete Response letter to include suggested additional analysis of existing clinical and non-clinical data. The FDA feedback did not indicate that new clinical studies would be required for re-submission. Importantly, the FDA 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 re-submission.

“We are encouraged by the FDA’s constructive feedback regarding the Vitaros NDA re-submission strategy and we appreciate their valuable input, which we believe will help to further strengthen our re-submission,” said Richard Pascoe, Chief Executive Officer of Apricus. “Importantly, we believe that we can adequately address the DDAIP safety and partner transference risk noted in the 2008 Complete Response letter and we can further strengthen our clinical benefit section in the planned re-submission, using a methodology provided to us by the FDA. However, given the determination by the FDA that Vitaros is now a drug-device combination, we will need to meet with the Office of Product Quality to clarify any additional conditions that may be required for approvability, which will likely delay our re-submission until the second half of 2017.”



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