San Diego-based Apricus Biosciences, Inc. said the U.S. Food and Drug Administration rejected its application for Vitaros to treat erectile dysfunction.
This is the second time the FDA turned down the application, identifying deficiencies related to chemistry, manufacturing and control and certain safety matters in a complete response letter.
The regulator's previous rejection noted that the pharmaceuticals company should provide additional analysis of existing clinical and nonclinical data but that it did not need new clinical studies in order to resubmit the application.
CEO of Apricus, Richard Pascoe, said in the press release: "We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission."
Vitaros, a topical cream, is already approved in Mexico, Canada, certain countries in Europe, Latin America and the Middle East.
Apricus secured the U.S. rights for Vitaros from Allergan plc. The agreement allows Allergan an option to jump back in and assume marketing and selling activities following U.S. FDA approval for $25 million in upfront payment and future milestone payments as well as royalty payments to Apricus.
The drug is managed outside the U.S. by Ferring International Center SA, Apricus' existing commercialization partner for Vitaros in Latin America and certain parts of Europe and Asia.
The company plans to update the market with its assessment of the prospects for the drug in early March.