FDA approves OTC antifungal Tolnaftate-D

August 19, 2011

Apricus Biosciences and its wholly owned subsidiary, NexMed USA, have received FDA approval for over-the-counter sales of antifungal drug Tolnaftate-D, containing the company's NexACT technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.

Apricus Biosciences and its wholly owned subsidiary, NexMed USA, have received FDA approval for over-the-counter sales of antifungal drug Tolnaftate-D, containing the company's NexACT technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.

The active ingredient in the cleared OTC drug, tolnaftate, is an already approved antifungal agent that can be sold as a cream, powder, spray, or liquid aerosol, and is currently used to treat jock itch, athlete's foot, and ringworm. It is sold under several third-party brand names, including Tinactin (Merck) and Lamisil AF (Novartis), among others.

With the approval of this drug, DDAIP, described by the company as the mainstay of the NexACT technology, is now listed as an excipient in an approved drug and is part of the U.S. monograph (the underlying FDA regulatory document). As such, DDAIP can be combined with active ingredients listed in the monograph to develop a greater number of OTC products that can be sold in the United States.

"We have been working on obtaining such status for over 8 months, and we believe that the cleared antifungal drug containing DDAIP and tolnaftate may be the first of many such OTC drugs that we and our partners will market and sell," said Bassam Damaj, MD, chairman, president and CEO of Apricus Bio, in a company press release.