REDWOOD CITY, Calif.,
April 11, 2019 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today announced an abstract about the safety
of DSUVIA™ has been selected, as one of the highest scoring
abstracts, for a moderated presentation at the 44th
Annual Regional Anesthesiology & Acute Pain Medicine Meeting
taking place from April 11-13 in
Las Vegas, Nevada. The
e-poster is available online at
http://epostersonline.s3.amazonaws.com/asraspring2019/asraspring2019.1bd06f2.NORMAL.pdf
This oral presentation covers the pooled safety results from
over 800 clinical study patients ranging in age from 18 to
86. The objective of the analysis performed was to evaluate
the pooled safety data by age group from the clinical studies of
sufentanil sublingual tablets in both postoperative and emergency
department patients.
"We are pleased to have one of the highest scoring abstracts and
be selected to present at ASRA's 2019 Spring meeting," said Dr.
Pamela Palmer, Co-Founder and Chief
Medical Officer at AcelRx Pharmaceuticals. "These pooled results
from our numerous clinical trials support the safe use of
sufentanil sublingual tablets across a broad age range of patients
in the emergency department and following a wide variety of
surgeries."
DSUVIA is indicated for use in adults in a certified medically
supervised healthcare setting, 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. Accidental exposure to or ingestion
of DSUVIA, especially in children, can result in respiratory
depression and death. Please see the full Indication,
Limitations of use and Important Safety Information, including the
Boxed Warning below.
Details on the
presentation are as follows:
|
Title:
|
Pooled Safety
Results by Age Cohort for the Overall Sufentanil Sublingual Tablet
30 mcg Safety Population
|
Presenter:
|
Dr. David Leiman -
Clinical Assistant Professor of Surgery & Director of HD
Research Corp, University of Texas at Houston
|
Date/Time:
|
Friday, April 12,
2019 at 4:00-5:30PM.
|
Location:
|
Caesars Palace, Las
Vegas, Nevada
|
About DSUVIA (sufentanil) sublingual tablet
Indications and Usage
DSUVIA is indicated for use in
adults in a certified medically supervised healthcare setting, 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.
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.
PLEASE SEE BELOW FOR THE IMPORTANT SAFETY INFORMATION,
INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
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.
Contraindications
Use of 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
- Known hypersensitivity to sufentanil or components of
DSUVIA.
Warnings and Precautions
- Accidental ingestion or exposure to even one dose of DSUVIA,
especially in children, can result in respiratory depression and
death due to an overdose of sufentanil.
- DSUVIA is for use in adult patients only in a certified
medically supervised healthcare setting. Use of DSUVIA outside of
this setting can increase the risk of accidental exposure in others
for whom it is not prescribed, causing fatal respiratory
depression. Discontinue use of DSUVIA prior to discharge or
transfer from the certified medically supervised healthcare
setting. DSUVIA is not for home or pediatric use.
- DSUVIA contains sufentanil, a Schedule II controlled substance.
As an opioid, DSUVIA exposes users to the risks of addiction,
abuse, and misuse.
- Profound sedation, respiratory depression, coma, and death may
result from the concomitant use of DSUVIA with benzodiazepines or
other CNS depressants (e.g., non-benzodiazepine
sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants,
general anesthetics, antipsychotics, other opioids, alcohol).
Because of these risks, reserve concomitant prescribing of these
drugs for use in patients for whom alternative treatment options
are inadequate.
- Life-threatening respiratory depression in patients with
chronic pulmonary disease or in elderly, cachectic and debilitated
patients: monitor patients closely, particularly when initiating
DSUVIA therapy and when DSUVIA is used with other drugs that
depress respiration. Management of respiratory depression may
include close observation, supportive measures, and use of opioid
antagonists, depending on the patient's clinical status.
- A potentially life-threatening condition could result from
concomitant serotonergic drug administration. Discontinue DSUVIA if
serotonin syndrome is suspected. Cases of adrenal insufficiency
have been reported with opioid use (usually > 1 month).
Presentation and symptoms are non-specific and include nausea,
vomiting, anorexia, fatigue, weakness, dizziness and low blood
pressure. Confirm diagnosis with testing as soon as possible and,
if confirmed, treat with physiologic replacement of corticosteroids
and wean patient from opioid.
- As with all opioids, sufentanil may produce bradycardia or
hypotension in some patients. Therefore DSUVIA should be used with
caution in patients with bradyarrhythmias or hypovolemia.
- DSUVIA should not be used in patients who may be particularly
susceptible to the intracranial effects of CO2retention,
such as those with evidence of increased intracranial pressure,
impaired consciousness or coma.
- Prolonged use of DSUVIA during pregnancy can result in
withdrawal in the neonate, which can be life-threatening. Observe
newborns for signs of neonatal opioid withdrawal syndrome and
manage accordingly. Advise pregnant women using opioids for a
prolonged period of this risk and ensure that appropriate treatment
will be available.
- Insufficient data are available on the use of DSUVIA in
patients with severe liver or kidney impairment. DSUVIA should be
used with caution in such patients due to the importance of these
organs in the metabolism and excretion of sufentanil.
Adverse Reactions
Adverse reactions are described, or
described in greater detail, in other sections of the
Prescribing Information:
- Life-Threatening Respiratory Depression [see Warnings
and Precautions (5.3)]
- Addiction, Abuse, and Misuse [see Warnings and
Precautions (5.4)]
- Adrenal Insufficiency [see Warnings and Precautions
(5.9)]
- Severe hypotension [see Warnings and Precautions
(5.10)]
- Gastrointestinal Adverse Reactions [see Warnings and
Precautions (5.12)]
- Seizures [see Warnings and Precautions (5.13)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and
Precautions (5.15)]
The most commonly reported adverse reactions (≥ 2% and
higher than placebo) were nausea, headache, vomiting, dizziness,
and hypotension.
Medical Information
For medical inquiries or to report
an adverse event, other safety-related information or product
complaints for a company product, please contact the AcelRx Medical
Information Contact Center at 1-855-925-8476
or AcelRxMedInfo@rmpdc.org.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see full Prescribing
Information and Directions For Use 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. The Company 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) 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. In the U.S., Zalviso is an
investigational drug and not approved. For additional information
about AcelRx, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.