Apricus will seek Canadian MycoVa approval in 2013
SAN DIEGO -- Apricus Biosciences Inc. said Monday it will ask Canadian regulators to approve its antifungal drug MycoVa in late 2013, and the company's shares rose in morning trading.
MycoVa is designed to treat onychomycosis, a persistent foot fungus infection that can cause pain as well as thickened and discolored toenails. Apricus said Health Canada feels that a new analysis of the company's clinical trials of MycoVa is sufficient to support its request for marketing approval. The company says MycoVa killed the nail fungus and approved the appearance of patients' nails in clinical trials, but it did not meet its main goal of completely curing the fungal infection.
Apricus said it expects to file for approval of MycoVa in the fourth quarter of 2013. The company's shares rose 7 cents, or 2.2 percent, to $3.33 in morning trading.
MycoVa is designed to be applied directly to the infected nail, and Apricus said its drug technology enhances absorption of the drug through the skin, nail plate and nail bed. The company said studies showed that MycoVa works at least as well as Loceryl, the standard treatment for the fungus in Europe, and it said MycoVa is safer than oral treatments.
The company said it is meeting with European Union regulators to discuss an eventual filing for marketing approval in the EU.