Apricus Biosciences (APRI) Receives FDA Clearance for Its Third OTC Drug Containing NexACT(R) Technology

SAN DIEGO, Aug. 31, 2011 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (“Apricus Bio” or the “Company”) (Nasdaq:APRI) (http://www.apricusbio.com) announced today that its wholly-owned subsidiary, NexMed USA, Inc., has received clearance from the U.S. Food and Drug Administration (“FDA”) for its third, over-the-counter (“OTC”) drug, Diphenhydramine-D™, containing the Company’s NexACT® technology.

“This latest clearance from the FDA of our third OTC drug containing our proprietary NexACT® drug delivery technology, illustrates the progress we have achieved in a relatively short period of time toward building out our OTC Consumer Healthcare Division, and puts us one step closer to being able to provide a full-line of OTC products in the topical area,” said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. “As such, we will continue to seek clearance for a number of additional OTC drugs in order to further expand this division and maximize the flexibility of our proprietary technology platform. In addition, we will be seeking partners with established distribution channels to partner with and commercialize these products,” he added.

The active ingredients in this OTC drug are diphenhydramine hydrochloride (2%) and zinc acetate (0.1%). Diphenhydramine hydrochloride is a topical analgesic and zinc acetate is a skin protectorant, both of which are in the OTC monograph and can be sold as creams. They are currently used in combination to treat itching associated with insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes due to poison ivy, poison oak and poison sumac. They are also used to dry the oozing and weeping caused by poison ivy, poison oak and poison sumac and are sold under several third party brand names, most notably Demarest (Fougera & Co.), Benadryl Extra Strength Itch Stopping Gel (McNeill PPC, Inc.) and Derma-Pax (Recsei Laboratories, Inc.).

Apricus Bio’s new Diphenhydramine-D™ product combines diphenhydramine hydrochloride and zinc acetate with DDAIP, the main ingredient in NexACT®, the Company’s proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells allowing for improved permeation of a drug through the cells to the target area.

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, 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 diphenhydramine hydrochloride and zinc acetate 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. The Company is also developing its over-the counter (“OTC”) Consumer Healthcare Division by seeking clearance for a number of drugs that contain active ingredients listed in the OTC drug monograph combined with Apricus Bio’s NexACT® technology.

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 Diphenhydramine-D™ and other 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.
         (858) 848-4249
         ecox@apricusbio.com

         Apricus Bio Investor Relations
         Paula Schwartz
         Rx Communications Group, LLC
         (917) 322-2216
         pschwartz@rxir.com