REDWOOD CITY, Calif.,
Dec. 13, 2013 /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 presented additional detail from
the Phase 2 dose-finding study of ARX-04, an investigational
single-dose sublingual sufentanil NanoTab for moderate-to-severe
acute pain, for which topline results were reported in April 2013. Patients treated with the 30 mcg dose
of sufentanil showed a rapid onset of action with a statistically
significant beneficial difference in pain relief (p<0.001) and
pain intensity (p<0.01) seen at 30 minutes after dosing compared
to placebo. Dosing averaged every 2.4 hours over the duration
of the 12-hour study. In addition, patient global assessment
of the 30 mcg dose at 12 hours was superior to placebo (p=0.002)
with 43.6% vs. 5.0% of the patients responding good or excellent
for overall pain control. The 20 mcg dose was not significant for
either endpoint. This study was funded by a grant from the
U.S. Army Medical Research and Materiel Command. These results are
being presented at the 67th Annual PostGraduate Assembly
in Anesthesia being held in New York
City.
"These additional analyses of data from our Phase 2 study
demonstrate a rapid onset of action and a sustained strong
analgesic effect for ARX-04 (30 mcg), a non-invasive, healthcare
provider-administered analgesic product candidate for the
short-term treatment of moderate-to-severe acute pain where
intravenous access may not be desirable or readily available,"
stated Dr. Pamela Palmer, Chief
Medical Officer, AcelRx Pharmaceuticals. "These data will be
reviewed in our End-of-Phase 2 meeting with the FDA later this
month in order to define the Phase 3 development program for
ARX-04, which we hope to initiate in the second half of 2014."
This dose-ranging study randomized 101 patients following
bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg
sufentanil or placebo treatment arms. The intent-to-treat
(ITT) population in this study averaged 42.5 years of age and was
evenly balanced for males and females (51%:49%). Ninety-one percent
of patients entering the study completed the full 12-hour study
period. SPID-12 (Summed Pain Intensity Difference to baseline
during the 12-hour study period) scores, the primary endpoint, were
+6.53 for 30 mcg sufentanil-treated patients and -7.12 for
placebo-treated patients, the difference between the two groups
being highly statistically significant (p=0.003). The 20 mcg
sufentanil-treated patients did not achieve SPID-12 scores that
differentiated from placebo. For the time-weighted sum of pain
relief scores over the 12-hour study period, or TOTPAR12, there was
a statistically significant difference in favor of the 30 mcg group
over placebo (9.73 vs. 4.37 p = 0.002).
Two serious adverse events (SAEs), both in the 20 mcg-dose
group, occurred one week after the study (surgical infections) and
were deemed unrelated to study drug. All but two adverse events
reported in the study were mild-to-moderate in nature with 58
patients (58%) reporting a total of 135 adverse events. The most
frequently reported adverse events for all patients were nausea
(30%), vomiting (17%), dizziness (14%) and somnolence (11%).
Two patients discontinued treatment, one unrelated to study drug
(anxiety/chest pain) and the other probably related to study drug
(somnolence/respiratory depression), however both patients
recovered without medical intervention.
About ARX-04
ARX-04 is a product candidate in development for the treatment
of moderate-to-severe acute pain, consisting of sufentanil, a high
therapeutic index opioid, formulated using AcelRx's proprietary
NanoTab technology that enables rapid sublingual absorption when
the NanoTab is placed under the tongue. As a result,
sufentanil NanoTabs are designed to provide rapid onset of
analgesia via a non-invasive route of administration and display a
consistent pharmacokinetic profile due to a high percentage of drug
being absorbed sublingually instead of through the gastrointestinal
tract. ARX-04, which is administered by a healthcare
professional using a simple, single dose administrator, may
ultimately be proven beneficial in a variety of medically
supervised settings, potentially including use in battlefield
injury, by paramedics during patient transport, in the emergency
room, for non-surgical patients experiencing pain in the hospital,
or for post-operative patients, following either short-stay or
ambulatory surgery who do not require more long-term
patient-controlled analgesia (PCA). According to the Centers
for Disease Control and Prevention data, there are more than 45
million injury-related emergency department visits and 43 million
ambulatory surgery procedures annually in the United States.
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, Zalviso™, 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 complexity of infusion
pumps. AcelRx has announced positive results from each of the three
completed Phase 3 clinical trials for Zalviso, and has submitted an
NDA to the FDA seeking approval for Zalviso in the treatment of
moderate-to-severe acute pain in adult patients in the hospital
setting. AcelRx has also announced positive top-line
results for a Phase 2 trial for ARX-04, a product candidate for the
treatment of moderate-to-severe acute pain in a medically
supervised setting, funded through a grant from the U.S. Army
Medical Research and Materiel Command. The company has two
additional pain treatment product candidates, ARX-02 and ARX-03,
which have completed Phase 2 clinical development. 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 process
and timing of anticipated future clinical development of ARX-04,
therapeutic and commercial potential of Zalviso and the anticipated
timing, and therapeutic and commercial potential of ARX-04 and
other AcelRx product candidates. These forward-looking
statements are based on AcelRx's current expectations and
inherently involve significant risks and uncertainties.
AcelRx's 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: AcelRx's ability to
receive regulatory approval for Zalviso, the fact that FDA may
dispute or interpret differently clinical results obtained to date;
the success, cost and timing of all product development activities
and clinical trials related to ARX-04; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including Zalviso, in the United
States and Europe; its
ability to attract funding partners or collaborators with
development, regulatory and commercialization expertise; its
ability to obtain sufficient financing to commercialize Zalviso;
the market potential for its product candidates, including ARX-04;
the accuracy of AcelRx's estimates regarding expenses, capital
requirements and needs for financing; and other risks detailed in
the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its Quarterly
Report on Form 10-Q filed with the SEC on November 5, 2013. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.