Apricus Biosciences Announces the Initiation of Vitaros Drug-Device Human Factors Study
(Thomson Reuters ONE) -
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(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 04.05.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 540344
Anzahl Zeichen: 5351
contact information:
Town:
SAN DIEGO
Kategorie:
Business News
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