Apricus Biosciences Receives FDA Clearance to Begin Clinical Trial of
RayVa(TM) for Secondary Raynaud's Phenomenon
Phase 2a Trial Expected to Commence Patient Enrollment in the Second Half of
SAN DIEGO, May 12, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a pharmaceutical company focusing on the development and
commercialization of novel therapeutics for men's and women's health, today
announced that the U.S. Food and Drug Administration (FDA) has cleared the
Company's Investigational New Drug (IND) application allowing the Company to
initiate clinical testing of RayVa^™, Apricus' product candidate for the
treatment of Raynaud's phenomenon. The Company expects to commence a Phase 2a
clinical trial and begin enrollment in the second half of 2014. RayVa combines
alprostadil, a vasodilator, with Apricus' proprietary permeation enhancer
DDAIP.HCl, and is applied as an on-demand topical cream to affected
extremities. In a nonclinical model, the Company demonstrated topical
administration of alprostadil cream to cold-challenge statistically improved
blood flow by 30 minutes relative to placebo, as measured by Laser Doppler.
The improvement in blood flow was maintained out to 90 minutes post-challenge.
"We are excited to bring our third product candidate into the clinic,
expanding our development pipeline beyond sexual health, and leveraging our
proprietary permeation enhancer technology, to address Raynaud's phenomenon
secondary to scleroderma, a disease that affects an estimated 100,000 people
in the United States^1," said Richard W. Pascoe, Chief Executive Officer.
"Secondary Raynaud's phenomenon disproportionately affects women and currently
has no approved therapy in the United States, representing an unmet medical
need. Patients suffering from secondary Raynaud's phenomenon are typically
treated by just over 4,500 rheumatologists in the United States^2, thus
providing Apricus with a potential path to building a focused commercial
organization in the future."
The randomized, double-blind, placebo-controlled, Phase 2a trial is expected
to enroll approximately fifty patients with Raynaud's phenomenon secondary to
scleroderma. Each patient will receive applications of placebo and doses of
RayVa, in a crossover design. This dose-ranging study will evaluate
hemodynamics and temperature at the site of application in response to a cold
challenge, as measured by Laser Doppler and thermography. Other endpoints
include safety and pharmacokinetic assessments. The FDA has indicated that
RayVa may qualify for priority review, given the unmet medical need and lack
of approved products to treat secondary Raynaud's phenomenon. The FDA will
determine if the RayVa New Drug Application qualifies for priority review
following its submission, which could occur as early as 2017.
About Raynaud's Phenomenon
Raynaud's phenomenon is characterized by vasoconstriction in the hands, feet
or other extremities, resulting in reduced blood flow and the sensation of
pain, which can become severe. It is classified as either primary or
secondary.Primary Raynaud's phenomenon, which is not associated with an
underlying medical condition, refers to vasoconstriction associated with
exposure to cold or stress.Primary Raynaud's phenomenon affects an estimated
3-5% of the US population, mostly women.^3Secondary Raynaud's phenomenon,
with symptoms similar to primary Raynaud's phenomenon, is driven by an
underlying medical condition, such as scleroderma, lupus or rheumatoid
arthritis.^4There are an estimated 100,000 adult patients with scleroderma in
the US^1, of which approximately 90% have secondary Raynaud's
phenomenon^4.Overall, there are approximately 500,000 adult patients with
secondary Raynaud's phenomenon in the US.^4,5
Approximately 80% of scleroderma patients are women.^6Both primary and
secondary Raynaud's phenomenon disproportionately affects women.^7There is
currently no approved therapy for Raynaud's phenomenon in the United States,
representing an unmet medical need.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for men's and women's
health. The Company's lead product, Vitaros^®, for the treatment of erectile
dysfunction, is approved in Europe and Canada and will be commercialized by
Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd.
(Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. The Company's
second-generation Vitaros room temperature device is under development and is
expected to enhance the product's commercial value.Femprox^®, the Company's
product candidate for the treatment of female sexual interest/arousal
disorder, has successfully completed an approximately 400-subject
proof-of-concept study. The Company is currently seeking a strategic partner
for Femprox.RayVa^™, the Company's product candidate for the treatment of
Raynaud's phenomenon, recently received FDA clearance to begin clinical
studies.The Company intends to begin a Phase 2a trial with RayVa in the
second half of 2014.
For further information on Apricus, visit http://www.apricusbio.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act, as amended.Statements in this
press release that are not purely historical are forward-looking statements.
Such forward-looking statements include, among other things: references to
the timing of the commencement of a Phase 2a clinical trial for RayVa™, the
size of the commercial opportunity for RayVa and the ability to build a
focused commercial organization for RayVa. Actual results could differ from
those projected in any forward-looking statements due to a variety of reasons
that are outside the control of the Company, including, but not limited to:
its ability to further develop its product candidate RayVa for the treatment
of Raynaud's phenomenon, as well as the timing of such events; Apricus'
ability to carry out clinical studies for RayVa, as well as the timing and
success of the results of such studies; Apricus' ability to raise additional
funding that it may need to continue to pursue its commercial and business
development plans; Apricus' ability to obtain the requisite governmental
approvals for RayVa; and market conditions.These forward-looking statements
are made as of the date of this press release, and Apricus assumes no
obligation to update the forward-looking statements, or to update the reasons
why actual results could differ from those projected in the forward-looking
statements. 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 at www.sec.gov or without charge
from the Company.
^1Barnes J and Mayes MD. Epidemiology of systemic sclerosis: incidence,
prevalence, survival, risk factors, malignancy, and environmental triggers.
Curr Opin Rheumatol 2012, 24:165–170.American College of Rheumatology
^2American Medical Association 2011.
^3Wigley FM. Raynaud's phenomenon. N Engl J Med. 2002; 347:1001–1008.Pope
JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67:
^4 Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007;
^5 2012 U.S. Census Bureau: State and County QuickFacts
^6 Gelber AC, Manno RL, Shah AA, Woods A, Le EN, Boin F, Hummers LK, Wigley
FM. Race and Association With Disease Manifestations and Mortality in
Scleroderma. Medicine 2013; 92: 191-205.
^7 National Institutes of Health
CONTACT: Steve Martin
Chief Financial Officer
Senior Vice President
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