REDWOOD CITY, Calif.,
Sept. 18, 2012 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced that Mike A. Royal, M.D., J.D., MBA, has joined the
company as Chief, Clinical Affairs. Mike Royal has board
certifications in internal medicine, pain medicine, and
anesthesiology with sub-specializations in pain management and
addiction medicine, along with extensive research, clinical and
corporate work experience. For the past six years, Dr. Royal
has worked at Cadence Pharmaceuticals, Inc. most recently as VP,
Clinical Development and Medical Affairs, where he was responsible
for activities such as the design, oversight, and completion of the
OFIRMEV® (acetaminophen) injection clinical development
program and new drug application, and medical support for
pre-launch and launch activities, which resulted in the rapid
acceptance of OFIRMEV onto hospital formularies.
"I am thrilled to welcome Mike to our executive leadership
team," said Richard King, AcelRx's
president and CEO. "I believe Mike's broad experience and
proven track record will be exceptionally helpful to AcelRx as we
approach late-stage clinical development and commercialization of
our lead product, the Sufentanil NanoTab PCA System."
"I am particularly excited at the prospect of being involved in
the development and commercialization of the novel sufentanil
NanoTab PCA System, which has the potential to significantly
improve pain management for post-operative patients," said Dr.
Royal.
Dr. Royal will be responsible for managing the late-stage and
post-approval clinical direction of AcelRx, as well as healthcare
professional focused Medical Affairs on behalf of the company.
This will include late-stage clinical trial design and
management, data analysis, clinical publications and medical
writing, product safety review and monitoring, and regulatory
interactions. Prior to Cadence Pharmaceuticals, Dr. Royal's
previous experience includes Solstice Neurosciences, where he
served as Chief Medical Officer, Alpharma, where he served as VP,
Strategic Brand Development and as VP, Global Medical Affairs, and
Elan Pharmaceuticals, where he was Senior Medical Director.
He currently serves on the clinical adjunct faculty at
University of California San Diego, and
was previously on faculty at the University of
Pittsburgh Medical Center and as an attending
anesthesiologist and pain physician, and director of the acute pain
service. Dr. Royal earned a B.S. in chemistry from the
Massachusetts Institute of Technology,
M.D. from the University of Massachusetts
Medical School, J.D. from the University of Maryland School of Law, and Global
EMBA joint degree awarded from TRIUM (New York
University Stern School, London School
of Economics, and Haute Ecole Commerciale).
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute and breakthrough
pain. AcelRx's lead product candidate, the ARX-01 Sufentanil
NanoTab PCA System, which is currently in Phase 3 clinical
development, is designed to solve the problems associated with
post-operative intravenous patient-controlled analgesia which has
been shown to cause harm to patients following surgery because of
the side effects of morphine, the invasive IV route of delivery and
the inherent potential for programming and delivery errors
associated with the complexity of infusion pumps. AcelRx has
two additional product candidates which have completed Phase 2
clinical development: ARX-02 for the treatment of cancer
breakthrough pain, and ARX-03 for mild sedation, anxiety reduction
and pain relief for patients undergoing painful procedures in a
physician's office. AcelRx plans to initiate a Phase 2 study,
pending protocol approval, for a fourth product candidate, ARX-04,
a sufentanil formulation for the treatment of moderate-to-severe
acute pain, funded through a grant from USAMRMC. For
additional information about AcelRx's clinical programs please
visit www.acelrx.com.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the planned or
anticipated future clinical development of AcelRx Pharmaceuticals'
product candidates, including the anticipated timing for the ARX-01
clinical trials, progress towards initiation of the Phase 2 study
for ARX-04, and the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates. These forward-looking
statements are based on AcelRx Pharmaceuticals' current
expectations and inherently involve significant risks and
uncertainties. AcelRx Pharmaceuticals' actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
the success, cost and timing of AcelRx Pharmaceuticals' product
development activities and clinical trials; the uncertain clinical
development process, including the risk that planned clinical
trials may not begin on time, have an effective design, enroll a
sufficient number of patients, or be initiated or completed on
schedule, if at all; any delays or inability to obtain, regulatory
approval of its product candidates; its ability to obtain adequate
clinical supplies of the drug and device components of its product
candidates; its ability to attract funding partners or
collaborators with development, regulatory and commercialization
expertise; its ability to obtain sufficient financing to complete
development and registration of its product candidates in
the United States and Europe; its ability to obtain and maintain
regulatory approvals of its product candidates; the market
potential for its product candidates; the accuracy of AcelRx
Pharmaceuticals' estimates regarding expenses, capital requirements
and needs for financing; AcelRx Pharmaceuticals' ability to repay a
portion of the principal under the loan and security agreement with
Hercules with common stock; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx Pharmaceuticals' U.S. Securities
and Exchange Commission filings and reports, including its
Quarterly Report on Form 10-Q for the three months ended
June 30, 2012. AcelRx
Pharmaceuticals undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of
new information, future events or changes in its expectations.
SOURCE AcelRx Pharmaceuticals, Inc.