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SAN DIEGO, Sept. 17, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (
http://www.apricusbio.com ) announced today publication in the current issue of the
Journal of Pharmaceutics and Drug Delivery Research of an article featuring Tolnaftate-D
™, the Company's over-the-counter ("OTC") antifungal product for the treatment of Athlete's Foot. The paper, entitled "Enhancing the Skin Flux of Tolnaftate Utilizing the Novel Excipient, Dodecyl-2-N,N-Dimethylaminopropionate (DDAIP)," was written by Susan R. Meier-Davis, DVM, PhD, DABT, RAC, the Company's Vice President of Safety. The published data demonstrates that Tolnaftate-D
™, Apricus Bio's novel tolnaftate formulation (tolnaftate 1% delivered using 0.5% DDAIP), resulted in a significant (57%) increase in penetration over a 24-hour period as compared to OTC tolnaftate 1%. The full article is available online at
Tolnaftate 1% is a widely used antifungal agent that is regarded by the FDA as generally recognized as safe and effective ("GRASE") as an OTC treatment for superficial fungal infections including Athlete's Foot, ringworm and jock itch. The customary treatment regimen is topical application of tolnaftate 1% cream on the affected area, twice daily. Penetration of an antifungal drug through the stratum corneum to reach the underlying epidermal and dermal layers is needed for effective topical treatment of fungal infections. To enhance the permeation of tolnaftate, Apricus Bio's Tolnaftate-D
™ contains NexACT
®, its novel penetration enhancer, and tolnaftate 1%. Utilizing human cadaver skin mounted on Franz cells, tolnaftate skin flux was evaluated with and without the presence of NexACT
®. The mean cumulative flux of tolnaftate 1% in 0.5% DDAIP over the 24-hour evaluation period was increased more than 3 times compared to 1% tolnaftate alone.
"Increased penetration of tolnaftate has the potential to reduce the number of applications and overall treatment duration necessary to clear a fungal infection," said Bassam Damaj, PhD, President and Chief Executive Officer of Apricus Bio. "In addition, resistance to antifungal therapy increases with duration of treatment, so development of a tolnaftate formulation with increased epidermal penetration could also decrease the potential for organism resistance. This publication is yet another example of the broadly applicable nature of our NexACT
® drug delivery technology."
About OTC Tolnaftate-D™ and NexACT ®
™ is Apricus Bio's first OTC antifungal product. The product incorporates tolnaftate 1% and NexACT
®, the Company's proprietary drug delivery technology that transiently loosens the tight junctions between skin cells to enhance permeation. DDAIP is a drug excipient and may be used with other GRASE active ingredients listed in final FDA OTC monographs to create and develop other potential proprietary OTC products. The Company filed for approval of its Tolnaftate-D
™ OTC product in Canada and is currently awaiting potential approval from the authorities in that country.
About Apricus Biosciences, Inc.
Apricus Bio (Nasdaq:APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The Company has four approved products and has developed a strong pipeline of multiple late-stage product opportunities. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenues and growth from sales of its commercial products and by out-licensing, in certain territories, its pipeline products and NexACT
Apricus Bio's growth strategy is to acquire, develop, and commercialize new products through strategic partnerships. The Company currently has commercial partnerships with multiple large pharmaceutical companies including Novartis, Abbott Laboratories, Takeda, Sandoz, Warner Chilcott and Bracco, and co-promotes multiple products in France.