Apricus Biosciences had a lot riding on its application to the FDA for its erectile dysfunction cream, Vitaros, with the product only one of two candidates in its pipeline and not a huge amount of cash reserves to fall back on.
After receiving a complete response letter (CRL), it looks like the small company has only a limited set of options left.
The press release on the FDA’s decision found that were safety concerns associated with the 2.5% concentration of Vitaros.