Apricus shares sink after failed erectile dysfunction application
pharmafile | February 19, 2018 | News story | Sales and Marketing | Apricus, biotech, drugs, pharma, pharmaceutical
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.
“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. 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,” stated Richard W. Pascoe, Chief Executive Officer.
As mentioned by Pascoe, this is the second time that Vitaros has gone before the FDA. 10 years ago the treatment was rejected on fears that the treatment could cause cancer in patients or their sexual partners.
An approval this time around was expected, with the product already being marketed across Europe, Canada, Mexico and other regions by Ferring International.
The expectation caused the share price of Apricus to rise to $3.19 before the announcement, before crashing to $1.04 – representing a loss of 67% of their value.
It leaves the company with an uncertain future regarding Vitaros and only RayVa, a potential treatment for Raynaud’s disease, as its other option. However, the latter is only at Phase 2a, with the company looking for a partner to continue clinical development.
Ben Hargreaves
Related Content
FDA approves IMIDEX’s AI-powered device VisiRad XR
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …
Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …
Zumutor’s cancer drug trial cleared by FDA
On 11 August 2023, the biopharmaceutical company Zumutor Biologics announced that the trial of its …
