The CRL identified deficiencies related to the chemistry, manufacturing and control and flagged certain safety concerns about the concentration contained in the formula.
Apricus Biosciences received a complete response letter for the second time in a decade from the US Food and Drug Administration (FDA) for the new drug application of alprostadil, DDAIP.HCI (Vitaros), a topical cream for the treatment of erectile dysfunction.
The response letter indicates that the FDA cannot move forward with the approval of the cream in its present form. The letter identified deficiencies related to the chemistry, manufacturing and control and flagged certain safety concerns specific to the 2.5% concentration of DDAIP.HCI contained in the current formula.
“We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market and update on our assessment in early March this year,” Richard Pascoe, chief executive officer, Apricus Biosciences, said in a statement.
Apricus Biosciences resubmitted a new drug application for Vitaros in August 2017 after receiving a complete response letter in 2008 that addressed deficiencies and questioned the DDAIP safety and partner transference risk.
While conducting a Type B meeting with the FDA in 2016 to confirm Apricus’ strategy for addressing the deficiencies contained in the 2008 response letter, the committee suggested including additional analysis of existing clinical and non-clinical data in the re-submitted NDA and did not indicate that new clinical studies would be required for re-submission.
Additionally, the FDA determined that Vitaros should be considered a drug-device combination and was advised to meet with the office of product quality to confirm the necessary compliance requirements for the 2017 NDA submission.
Vitaros has been approved in Canada, Mexico and certain countries in Europe, Latin America and the Middle East.
The topically-applied cream formulation dilates blood vessels, combined with a proprietary permeation enhancer NexACT, which directly increases blood flow.
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