Apricus Biosciences, a biopharmaceutical company urology and rheumatology focused drug-maker, will have to fire another shot at getting its topical cream Vitaros for the treatment of erectile dysfunction to the market. The company’s common stocks price had a sharp fall to $1.04, after previous close at $3.19. Apricus said Friday the FDA saw flaws and it wasn’t convinced that the concentration of DDAIP.HCI in the current formulation meets the safety requirements.
In a complete response letter (CRL) that the the U.S. Food and Drug Administration has issued for the New Drug Application (NDA) of Vitaros, it said it had identified deficiencies related to Chemistry, Manufacturing and Control (CMC) and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl.
Apricus’s CEO Richard W. Pascoe, is – of course – not satisfied with the outcome of the review. However, he said that regulatory experts are getting a closer look at the response letter to find the way to resolve the missing links for getting the approval for its cream. He said the market will be updated on the company’s assessment in early March this year.
Vitaros is Apricus’s product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan.