What's Next For Apricus Biosciences' Vitaros?

Apricus Biosciences Inc APRI receded 67.4 percent Friday and continued down Tuesday after the U.S. Food and Drug Administration issued a response letter for Vitaros.

The FDA declined to approve the New Drug Application after identifying safety concerns and deficiencies in the erectile dysfunction treatment related to chemistry, manufacturing and control.

What Does It All Mean?

Complete Response Letters indicate the FDA has completed review of a drug application and declined to approve marketing for the candidate in its existing form.

After receiving the letter, a company can either resubmit the application or an efficacy supplement and start a new review cycle; withdraw the application altogether; or request a hearing to question the grounds for denial.

The process undoubtedly delays the marketing and sale of a drug candidate.

What’s Next?

Apricus has not yet determined its next steps for Vitaros but intends to provide an update within the next month.

"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,” CEO Richard Pascoe said in a press release.

“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 an update on our assessment in early March of this year.”

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