Apricus Biosciences (APRI) Gets FDA Approval Of Anti-Fungal Drug Tolnaftate-D
SAN DIEGO, Aug 18, 2011 (GlobeNewswire via COMTEX) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") /quotes/zigman/121090/quotes/nls/apri APRI -1.68% ( http://www.apricusbio.com ) announced today that its wholly owned subsidiary, NexMed USA, has received clearance from the U.S. Food and Drug Administration ("FDA") to market its first anti-fungal, over-the-counter ("OTC") drug, Tolnaftate-D(TM), containing the Company's NexACT(R) technology.
"This is the first approval by the FDA of a drug containing Apricus Bio's NexACT(R) drug delivery technology, and as such, is a very important milestone for us," explained Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. "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, is an already approved anti-fungal 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, most notably Tinactin(R) (Merck) and Lamisil AF(R) (Novartis), among others.
Apricus Bio's Tolnaftate-D(TM) incorporates NexACT(R), the Company's proprietary drug delivery technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.
With the approval of this drug, DDAIP, the mainstay of the Company's NexACT(R) 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, which can be sold in the U.S.
"We have been working on obtaining such status for over eight months and we believe that the cleared anti-fungal drug containing DDAIP and tolnaftate may be the first of many such OTC drugs that we and our partners will market and sell," stated Dr. Damaj. "In addition, being added to the monograph permits us to work with other companies in developing combinations of our NexACT(R) technology with the potentially hundreds of active ingredients listed in the monograph and to develop their proprietary drugs using NexACT(R) at the concentration used in our approved Tolnaftate-D(TM) OTC drug."
According to the FDA, OTC products can be marketed under the authority of an approved product-specific new drug application ("NDA"), abbreviated NDA ("ANDA") or under and OTC drug monograph. Unlike NDAs, which are based on drug products, monographs specify the active ingredients that can be contained within OTC drug products. In addition to specifying the active ingredients, the OTC monographs contain information regarding the permitted concentrations of active ingredients, dosage limits, indications, and other requirements for legal marketing under monograph status. To view the current U.S. monographs for OTC products, please go to http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf (to view by Active Ingredient), or http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf (to view by Monograph Category).
To view the current approval listing, please go to http://dailymed.nlm.nih.gov and type Tolnaftate in the search index.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT(R) drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros(R), approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com . You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio .
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to receive issued patents on its NexACT(R) technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros(R) approved by relevant regulatory authorities, to successfully commercialize such products including over-the-counter products ("OTC") and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.