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Apricus Biosciences Announces FDA Clearance for Its Second OTC Anti-Itch Drug (Hydrocortisone-D(TM)) Containing NexACT(R) Technology

Date : 08/23/2011 @ 10:18AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)

http://ih.advfn.com/p.php?pid=nmona&article=48924600

Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (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 second, over-the-counter ("OTC") anti-itch drug, Hydrocortisone-D™, containing the Company's NexACT® technology.

"This is the second clearance by the FDA of a drug containing Apricus Bio's NexACT® drug delivery technology, and as such, enhances our strategy of building out our OTC products division and creating a new revenue-generating portfolio for the Company," explained Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio."

The active ingredient in the cleared OTC drug, hydrocortisone, is an already approved anti-itch agent, which can be sold as a cream. It is currently used to treat itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, and psoriasis (among others). It is sold under several third party brand names, most notably Cortizone® (Chattem/Sanofi Aventis) and Cortaid® (Johnson & Johnson).

Apricus Bio's new Hydrocortisone-D™ product combines hydrocortisone with DDAIP, the main ingredient in NexACT®, the Company's proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells to allow more permeation.

"Since January we have been working on building out our OTC portfolio. With Tolnaftate-D™ having been cleared last week and Hydrocortisone-D™ coming in this week, we are creating a new division that can contribute to both near-term revenues and long-term growth," stated Dr. Damaj.

According to the FDA, OTC products can be marketed under the authority of an approved product-specific new drug application ("NDA") or an abbreviated NDA ("ANDA"), or under an OTC drug monograph. Unlike NDAs, which are based on drug products, monographs specify the active ingredients that can be contained in 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 Hydrocortisone 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® 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®, 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® technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros® 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.

CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
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Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
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