Supplier News Breaks Archives
Apricus antifungal drug cleared by FDA
August 19th, 2011
SAN DIEGO – NexMed USA, a subsidiary of Apricus Biosciences Inc., has been approved by the Food and Drug Administration to market Tolnaftate-D, the company's first over-the-counter antifungal medication with its NexACT technology.
Apricus said Thursday that the active ingredient in the OTC drug, tolnaftate, has already been approved as an 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. It is sold under several third-party brand names, notably Tinactin (Merck) and Lamisil AF (Novartis).
Tolnaftate-D incorporates NexACT, the Apricus' proprietary drug delivery technology, which the company said 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," according to Dr. Bassam Damaj, chairman, president and chief executive officer of Apricus. "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."