PresseKat - DGAP-News: Apricus Biosciences Receives FDA Clearance for Its Third OTC Drug Containing NexACT(R) Te

DGAP-News: Apricus Biosciences Receives FDA Clearance for Its Third OTC Drug Containing NexACT(R) Technology

ID: 471403

(firmenpresse) - Apricus Biosciences, Inc.

31.08.2011 15:47
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SAN DIEGO, 2011-08-31 15:47 CEST (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(tm), containing the Company's NexACT(r) technology.

'This latest clearance from the FDA of our third OTC drug containing our
proprietary NexACT(r) 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(tm) product combines diphenhydramine
hydrochloride and zinc acetate with DDAIP, the main ingredient in NexACT(r), the
Company's proprietary drug delivery technology. NexACT(r) 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 hydrochlorideand 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(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. 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(r) 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(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 Diphenhydramine-D(tm) 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(at)apricusbio.com

Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz(at)rxir.com
News Source: NASDAQ OMX



31.08.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

DGAP's Distribution Services include Regulatory Announcements,
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Language: English
Company: Apricus Biosciences, Inc.


United States
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ISIN: US9901429525
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End of Announcement DGAP News-Service

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Datum: 31.08.2011 - 15:47 Uhr
Sprache: Deutsch
News-ID 471403
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