REDWOOD CITY, Calif.,
July 23, 2020 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company, today announced an agreement to market
DSUVIA®, a sublingual opioid tablet in a single-dose applicator,
within the dental and oral surgery markets in the United States exclusively through Zimmer
Biomet's Dental division. The agreement expands the U.S.
availability of the non-invasive, sublingual analgesic for use by
dental healthcare professionals in medically supervised settings
who currently use injectable opioids for surgical analgesia.
DSUVIA is indicated for use in adults in certified medically
supervised healthcare settings for the management of acute pain
severe enough to require an opioid analgesic, and for which
alternative treatments are inadequate.
DSUVIA manages acute pain during
procedures with its unique
pharmacokinetic profile, which avoids the high peak plasma
levels and short duration of action observed with bolus IV
administration. The single dosage-strength tablet administered
sublingually mitigates potential clinical issues such as dosage
miscalculations or IV administration challenges.
"We are proud to be partnering with Zimmer Biomet to provide
DSUVIA as an option for acute pain management in adults during oral
surgeries," said Vince Angotti, CEO
of AcelRx Pharmaceuticals. "This strategic alliance with an
established and reputable partner with a strong, solution-based
sales network enables AcelRx to support dental professionals and
their care of patients during the millions of oral surgeries in
the United States each year. This
partnership, together with other ongoing business development
activities and the recent military Milestone C approval, are
evidence of the continued execution on our strategy to build
long-term value."
DSUVIA is expected to be available for order by certified dental
and oral surgeons exclusively through Zimmer Biomet in the United States after satisfaction of
applicable licensing requirements.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in
certified medically supervised healthcare settings, such as
hospitals, surgical centers, and emergency departments, for the
management of acute pain severe enough to require an opioid
analgesic, and for which alternative treatments are inadequate.
DSUVIA was designed to provide rapid analgesia via a non-invasive
route and to eliminate dosing errors associated with intravenous
(IV) administration. DSUVIA is a single-strength solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
previously only marketed for IV and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile
when delivered sublingually avoids the high peak plasma levels and
short duration of action observed with IV administration. The
European Commission approved DZUVEO for marketing in Europe in June
2018 and the Company is currently in discussions with
potential European marketing partners. For more information, please
visit www.DSUVIA.com.
LIMITATIONS OF USE
Not for home use or for use in
children. Discontinue treatment with DSUVIA before patients leave
the certified medically supervised healthcare setting. Not for use
for more than 72 hours.
The use of DSUVIA beyond 72 hours has not been studied.
Only to be administered by a healthcare provider. Because of the
risks of addiction, abuse, and misuse with opioids, even at
recommended doses, reserve DSUVIA for use in patients for whom
alternative treatment options [e.g., non-opioid analgesics or
opioid combination products]: have not been tolerated, or are not
expected to be tolerated; have not provided adequate analgesia, or
are not expected to provide adequate analgesia.
The Full Prescribing Information for DSUVIA contains the
following Boxed Warning:
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM;
LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND
MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Accidental Exposure and DSUVIA Risk Evaluation and Mitigation
Strategy (REMS) Program: Accidental exposure to or
ingestion of DSUVIA, especially in children, can result in
respiratory depression and death. Because of the potential for
life-threatening respiratory depression due to accidental exposure,
DSUVIA is only available through a restricted program called the
DSUVIA REMS Program. DSUVIA must only be dispensed to patients in a
certified medically supervised healthcare setting. Discontinue use
of DSUVIA prior to discharge or transfer from the certified
medically supervised healthcare setting.
Life-Threatening Respiratory Depression: Serious,
life-threatening, or fatal respiratory depression may occur with
use of DSUVIA. Monitor for respiratory depression, especially
during initiation of DSUVIA.
Addiction, Abuse, and Misuse: DSUVIA exposes patients and
other users to the risks of opioid addiction, abuse, and misuse,
which can lead to overdose and death. Assess each patient's risk
prior to prescribing DSUVIA, and monitor all patients regularly for
the development of these behaviors or conditions.
Cytochrome P450 3A4 Interaction: The concomitant use of
DSUVIA with all cytochrome P450 3A4 inhibitors may result in an
increase in sufentanil plasma concentrations, which could increase
or prolong adverse drug reactions and may cause potentially fatal
respiratory depression. In addition, discontinuation of a
concomitantly used cytochrome P450 3A4 inducer may result in an
increase in sufentanil plasma concentration. Monitor patients
receiving DSUVIA and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS
Depressants: Concomitant use of opioids with benzodiazepines or
other central nervous system (CNS) depressants, including alcohol,
may result in profound sedation, respiratory depression, coma, and
death. Reserve concomitant prescribing for use in patients for whom
alternative treatment options are inadequate. Limit dosages and
durations to the minimum required. Follow patients for signs and
symptoms of respiratory depression and sedation.
IMPORTANT SAFETY INFORMATION
DSUVIA is contraindicated
in patients with significant respiratory depression; acute or
severe bronchial asthma in an unmonitored setting or in the absence
of resuscitative equipment; known or suspected gastrointestinal
obstruction, including paralytic ileus; and known hypersensitivity
to sufentanil or components of DSUVIA.
DSUVIA contains sufentanil, a Schedule II controlled substance.
As an opioid, DSUVIA exposes users to the risks of addiction,
abuse, and misuse. Potential serious adverse events caused by
opioids include addiction, abuse, and misuse, life-threatening
respiratory depression, neonatal withdrawal syndrome, risks of
concomitant use or discontinuation of cytochrome P450 3A4
inhibitors and inducers, risks from concomitant use with
benzodiazepines or other CNS depressants, risk of life threatening
respiratory depression in patients with chronic pulmonary disease
or in elderly, cachectic, or debilitated patients, adrenal
insufficiency, severe hypotension, risks of use in patients with
increased intracranial pressure or impaired consciousness,
gastrointestinal disorders and seizure disorders. DSUVIA should be
used with caution in patients with severe liver or kidney
impairment.
This is not a complete list of risks associated with DSUVIA. For
additional Important Safety Information please see full Prescribing
Information at www.DSUVIA.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for use in medically supervised
settings. AcelRx's proprietary, non-invasive sublingual
formulation technology delivers sufentanil with consistent
pharmacokinetic profiles. AcelRx has one approved product in the
U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg),
known as DZUVEO™ in Europe,
indicated for the management of acute pain severe enough to require
an opioid analgesic for adult patients in certified medically
supervised healthcare settings, and one product candidate,
Zalviso® (sufentanil sublingual tablet system, SST
system, 15 mcg), an investigational product in the U.S., is being
developed as an innovatively designed patient-controlled analgesia
(PCA) system for reduction of moderate-to-severe acute pain in
medically supervised settings. DZUVEO and Zalviso are both approved
products in Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
but not limited to, statements related to the commercial
opportunity of AcelRx's agreement with Zimmer Biomet and the
anticipated timing of the availability of DSUVIA to certified
dental and oral surgeons. These and any other forward-looking
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These statements
may be identified by the use of forward-looking terminology such as
"believes," "expects," "anticipates," "may," "will," "should,"
"seeks," "approximately," "intends," "plans," "estimates," or the
negative of these words or other comparable terminology. The
discussion of financial trends, strategy, plans or intentions may
also include forward-looking statements. These forward-looking
statements involve risks and uncertainties that could cause actual
results to differ materially from those projected, anticipated or
implied by such statements, including the risk that AcelRx may not
experience the expected benefits from the commercial opportunity
and Zimmer Biomet may be unable to acquire the necessary licenses.
Although it is not possible to predict or identify all such risks
and uncertainties, they may include, but are not limited to, those
described in AcelRx's annual, quarterly and current reports (i.e.,
Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with
the Securities and Exchange Commission (SEC). You are
cautioned not to place undue reliance on any such forward-looking
statements, which speak only as of the date such statements were
first made. AcelRx's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to
the extent required by law, AcelRx undertakes no obligation to
publicly release the result of any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof, or to reflect the occurrence of unanticipated
events.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/acelrx-announces-exclusive-distribution-and-promotion-partnership-for-dsuvia-301098641.html
SOURCE AcelRx Pharmaceuticals, Inc.