FDA grants regulatory guidance for nail fungus treatment
SAN DIEGO — Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.
Apricus said Tuesday that the FDA granted its request for guidance concerning MycoVa (terbinafine hydrochloride) that will help determine the suitability of the drug's clinical trial data to support regulatory approval. The drug uses a common treatment for nail fungus, also known as onychomycosis, delivered using the company's special drug delivery technology.
"This FDA guidance is an integral step in the process of bringing the safe and effective treatment benefits of MycoVa to patients suffering from mild to moderate onychomycosis," Apricus president and CEO Bassam Damaj said. "Extensive clinical trial data and a robust international patent estate firmly support the marketing potential of MycoVa, and we look forward to receiving necessary guidance from the FDA to move the process forward in the U.S."