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SAN DIEGO — NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company's first over-the-counter antifungal drug, Tolnaftate-D.
NexMed USA's Tolnaftate-D incorporates NexACT, a proprietary drug delivery technology that transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.
"This is the first approval by the FDA of a drug containing Apricus Bio's NexAct drug delivery technology, and as such, is a very important milestone for us," said Bassam Damaj, chairman, president and CEO of Apricus Bio, NexMed USA's parent company. "In particular, we believe this is a crucial validation of our technology. Our expectation is that this may represent just the first of many such OTC drugs containing our proprietary technology."
The active ingredient in the cleared OTC drug, tolnaftate, already is an approved antifungal agent, which can be sold as a cream, powder, spray or liquid aerosol, and is currently used to treat jock itch, athlete's foot and ringworm. With the approval of this drug, DDAIP, the mainstay of the company's NexAct technology, now is listed as an excipient in an approved drug and is part of the U.S. monograph. As such, DDAIP can be combined with active ingredients listed in the monograph to develop a greater number of OTC products.
"We have been working on obtaining such status for over eight 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," Damaj said. "In addition, being added to the monograph permits us to work with other companies in developing combinations of our NexAct technology with the potentially hundreds of active ingredients listed in the monograph and to develop their proprietary drugs using NexAct at the concentration used in our approved Tolnaftate-D OTC drug."