REDWOOD CITY, Calif.,
Nov. 2, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for use in a medically
supervised setting, announced today the approval of DSUVIA™ by the
U.S. Food and Drug Administration (FDA). DSUVIA is indicated for
the management of acute pain in adults that is severe enough to
require an opioid analgesic in certified medically supervised
healthcare settings, such as hospitals, surgical centers, and
emergency departments.
"The FDA approval of DSUVIA is the culmination of nearly 15
years of research to improve the standard of care for managing
acute pain in medically supervised settings," said Dr. Pamela Palmer, Co-Founder and Chief Medical
Officer, AcelRx. "As an anesthesiologist, I've seen the challenges
that IV opioids pose to patients and providers, such as logistical
delays in initiating IV lines, difficulty in accessing veins, and
medication errors with injectable opioids. AcelRx was founded to
develop a simple, effective, non-invasive analgesic option to
enable healthcare professionals to rapidly manage their patients'
acute pain."
DSUVIA is a 30 microgram (mcg) sufentanil tablet in a
single-dose, pre-filled applicator for under the tongue
(sublingual) administration by a healthcare professional only in
certified medically supervised settings. In a randomized,
double-blind, placebo-controlled clinical study, DSUVIA
demonstrated a statistically greater summed pain intensity
difference from baseline over the first 12 hours of the study
(SPID12) compared to placebo. The pain intensity difference from
baseline was superior to that of the placebo group within 15
minutes and median meaningful pain relief occurred following a
single dose. The single-strength tablet and single-unit packaging
are designed to mitigate the possibility of dosing errors, misuse
and diversion. The sublingual administration makes DSUVIA an option
for patients with nothing by mouth (NPO) status and patients with
difficult IV access (obese, elderly, burn or needle-phobic
patients). Avoiding an IV has the potential to offer efficiency
improvements in healthcare settings and improve patient experience.
There are an estimated 92 million annual adult patient visits to
medically supervised settings for moderate-to-severe acute pain. An
estimated 51 million of these visits are to emergency departments
(ED), with an estimated 18 million of these ED patients receiving
an IV only for pain management.1
"Managing acute pain is critical to a patient's recovery
process, especially in the postoperative setting, but current oral
and IV opioid analgesics can be slow-acting and challenging to dose
and administer, which in turn can limit optimal pain relief and
even be dangerous to patients," said Dr. David Leiman, Clinical Assistant Professor of
Surgery, University of Texas at Houston
and Director of HD Research. "As a single-dose, non-invasive
medication with a rapid reduction in pain intensity, DSUVIA
represents an important alternative for healthcare providers to
offer patients for acute pain management."
"The approval of DSUVIA, which was developed in collaboration
with the Department of Defense, underscores our commitment to
provide innovative therapies for use in medically supervised
settings," said Vince Angotti, Chief
Executive Officer, AcelRx. "We believe the unique features of
DSUVIA are an important leap forward in the management of acute
pain and patient care in these settings. We are committed to the
safe and effective administration of DSUVIA through diligent
adherence to our FDA-approved Risk Evaluation and Mitigation
Strategies program."
The DSUVIA commercial launch is expected in the first quarter of
2019.
DSUVIA efficacy and safety information
The efficacy
and safety of DSUVIA were evaluated in one randomized,
double-blind, placebo-controlled trial which enrolled 161 patients
(age 18 to 69 years) with acute postoperative pain (pain intensity
of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery
(studied up to 48 hours). Patients were dosed with DSUVIA 30
mcg or placebo as needed with a minimum of 60 minutes between
doses. Morphine sulfate 1 mg IV was available as rescue
medication.
Patients using DSUVIA had a statistically significantly greater
SPID12 than patients using placebo. Approximately 22% of patients
in the DSUVIA group and 65% of patients in the placebo group took
rescue medication within the first 12 hours of the treatment
phase.
In controlled and uncontrolled studies, the safety of DSUVIA was
evaluated in a total of 646 patients with moderate-to-severe
postoperative pain or pain due to trauma which required opioid
analgesia. The most frequently reported adverse reactions ≥ 2% in
the randomized, placebo-controlled trial were nausea, headache,
vomiting, dizziness, and hypotension. The DSUVIA clinical program
builds upon the established safety and efficacy of the reference
product, sufentanil citrate injection, which has been in commercial
use for over three decades.
DSUVIA will not be available in retail pharmacies or for
outpatient use. DSUVIA will only be distributed to health care
settings certified in the DSUVIA Risk Evaluation and Mitigation
Strategy (REMS) program following attestation by an authorized
representative that the healthcare setting will comply with
appropriate dispensing and use restrictions of DSUVIA. As part of
the REMS program, AcelRx will monitor distribution and audit
wholesalers' data, evaluate proper usage within the healthcare
settings and monitor for any diversion and abuse. Additionally,
AcelRx will de-certify healthcare settings that are non-compliant
with the REMS program.
Conference-call information
AcelRx will host a
conference call Monday, November 5th
at 8:30 a.m. Eastern Time to discuss
the FDA approval of DSUVIA. The call can be accessed by
dialing (866) 361-2335 for domestic callers, (855) 669-9657 for
Canadian callers or (412) 902-4204 for international callers. The
call will also be webcast live on the Company's website
at www.acelrx.com.
About DSUVIA™ (sufentanil sublingual tablet, 30
mcg)
DSUVIA™, known as DZUVEO™ outside the
United States, approved by the FDA
in November 2018, 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. DSUVIA was designed to provide rapid analgesia via
a non-invasive route and to eliminate dosing errors associated with
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
currently marketed for intravenous (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 Medicines Agency (EMA) approved DZUVEO for marketing in
Europe in June 2018. 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 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 available only
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
setting.
Life-Threatening Respiratory
Depression:
Serious, life-threatening,
or fatal respiratory depression may occur with the 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 patient's
risk before 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 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; and 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.
For Important Safety Information including full prescribing
information, visit: www.DSUVIA.com.
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
DSUVIA is funded in part by the Clinical and Rehabilitative
Medicine Research Program (CRMRP) of the U.S. Army Medical
Research and Materiel Command (USAMRMC) under contract No.
W81XWH-15-C-0046. The CRMRP was established in 2008 to foster
research and technology advances for regeneration, restoration, and
rehabilitation of traumatic injuries. In accordance with USAMRMC
guidelines, in the conduct of clinical research, AcelRx has adhered
to the policies regarding the protection of human subjects as
prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1,
Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1,
Part 50 (Protection of Human Subjects).
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.
For additional information about AcelRx, please visit
www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements, including, without limitation,
statements related to the safety, efficacy and tolerance of DSUVIA
and the planned timing for the commercial launch of DSUVIA. These
forward-looking statements are based on AcelRx's current
expectations and involve significant risks and uncertainties.
AcelRx's actual results and timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, including,
without limitation: any delays in the commercial launch of DSUVIA
or the Company's other approved products or the inability to
maintain regulatory approval of DSUVIA in the United States, and other risks detailed in
the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its Annual
Report on Form 10-K filed with the SEC on March 9, 2018 and Quarterly Report on Form 10-Q
filed with the SEC on August 2, 2018.
AcelRx 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,
except as required by law.
1 Source: Aggregated Medical Literature review,
QuintilesIMS primary market research, QuintilesIMS analysis 2016.
ARX-04 and Zalviso US data-December
2016.
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SOURCE AcelRx Pharmaceuticals, Inc.