Apricus Biosciences, Inc (APRI) said Tuesday it has filed a re-submission of its new drug application for the erectile dysfunction drug Vitaros with the US Food and Drug Administration after having received a complete response letter that pointed out deficiencies in the original submission.
The company said it expects the FDA to take six months to review the application and for a prescription drug user fee act goal date in Q1 of 2018, which the regulator is expected to acknowledge within 30 days of the NDA filing date.
“We believe we have completely addressed the deficiencies noted in the complete response letter and strengthened the overall Vitaros risk-reward profile with the goal of bringing an innovative erectile dysfunction treatment to patients whose needs are not met by currently approved therapies,” CEO Richard Pascoe said.
Apricus in-licensed Vitaros from Allergan (AGN) under a license deal struck in 2015. Upon FDA approval for Vitaros, Allergan may elect to exercise a one-time opt-in right to assume all future marketing and selling activities in the United States.
If Allergan exercises its opt-in right, Apricus may receive up to a total of $25 million in upfront and potential launch milestone payments, plus a double-digit royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may commercialize Vitaros and in return will pay Allergan a double-digit royalty on net sales of Vitaros.