Vitaros U.S. NDA Re-Submission on Track for Third Quarter 2017
SAN DIEGO, May 04, 2017 (GLOBE
NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a
biopharmaceutical company advancing innovative medicines in urology
and rheumatology, today reported that the Vitaros drug-device
combination human factor testing study required by the Food and
Drug Administration (FDA) is underway.
"In November of 2016, the FDA
designated Vitaros as a drug-device combination and required
Apricus to provide additional information regarding the proper use
of the applicator in the planned NDA re-submission," stated Richard
W. Pascoe, Chief Executive Officer. "We have since confirmed the
necessary regulatory requirements for a drug-device combination
product and have initiated the required human factors study which
we believe is in accordance with the FDA guidance. We expect this
study will be completed in the second quarter of this year and the
results will be incorporated into our planned Vitaros NDA
re-submission, which remains on track for the third quarter of this
year."
About
Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI)
is a biopharmaceutical company advancing innovative medicines in
urology and rheumatology. Apricus has two product candidates
currently in development. Vitaros is a product candidate in
the United States for the treatment of erectile dysfunction, which
is in-licensed from Warner Chilcott Company, Inc., now a subsidiary
of Allergan plc (Allergan). RayVa is our product candidate in Phase
2 development for the treatment of the circulatory disorder
Raynaud's phenomenon, secondary to scleroderma, for which Apricus
owns worldwide rights.
For further information on
Apricus, visit http://www.apricusbio.com.
Vitaros(TM) is
Apricus' trademark in the United States, which is pending
registration and subject to the agreement with Allergan.
Vitaros® is a
registered trademark of Ferring International Center S.A. in
certain countries outside of the United States.
RayVa(TM) is
Apricus' trademark, which is registered in certain countries
throughout the world and pending registration in the United
States.
Forward
Looking Statements
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: the timing of the completion of the drug-device combination
human factor study; the ability of the drug-device combination
study to provide results which can be incorporated into Apricus'
planned Vitaros NDA resubmission; and the timing of regulatory
submission and approval of Vitaros in the United States, if any.
Actual results could differ from those projected in any
forward-looking statements due to a variety of reasons that are
outside the control of Apricus, including, but not limited to: the
protocol for the drug-device combination human factor study may not
be in compliance with the FDA guidance; the study may produce
negative results; Apricus' may not be able to obtain FDA and other
requisite governmental approval for Vitaros; Apricus' ability to
further develop Vitaros, such as delivery device improvements, may
be limited or unsuccessful; Apricus' ability to carry out further
clinical studies for Vitaros, if required, 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; 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
Apricus' 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 Apricus.
CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933