(Reuters) – Drugmaker Apricus Biosciences Inc said on Monday it was considering strategic options after the U.S. Food and Drug Administration told it to develop a new formula for its erectile dysfunction cream Vitaros.
The company said it did not have the money to develop a new version of the drug after the FDA requested two new late-stage studies to test a reformulated product. The FDA has rejected Vitaros twice in a decade.
“We have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset,” Chief Executive Officer Richard Pascoe said.
The company said its board determined it should evaluate strategic alternatives or other business combinations.
Vitaros is approved in several countries, but has been rejected by the FDA for safety concerns.
Reporting by Tamara Mathias in Bengaluru; Editing by Anil D’Silva