AcelRx Announces Positive Results from a Phase 2 Study of ARX-03, a Sufentanil/Triazolam NanoTab for Procedural Sedation, Anxiolysis & Analgesia
REDWOOD CITY, Calif., Oct. 22 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. today announced positive results from a Phase
2 clinical trial of ARX-03, a proprietary sublingual dosage form
combining an opioid, sufentanil, with a benzodiazepine, triazolam.
ARX-03 is designed to address the current unmet need for a
non-invasive product to provide mild sedation, anxiolysis and
analgesia with rapid onset of action for the increasing number of
painful and anxiety-producing office-based procedures. The
objective of this randomized, double-blind, placebo-controlled
study was assessment of safety, tolerability and efficacy of ARX-03
relative to placebo in patients undergoing an elective low-volume
abdominal liposuction procedure.
In the study, 40 patients were randomized to receive either a
single sublingual dose of ARX-03 (sufentanil 15 mcg/triazolam 200
mcg NanoTab(TM)) or placebo prior to the injection of a local
anesthetic and the subsequent liposuction procedure. The primary
endpoint was efficacy of ARX-03 compared to placebo in providing
mild sedation during the procedure, as assessed using the
validated, objective Richmond Agitation-Sedation Scale (RASS). The
cumulative RASS score over the 4-hour study period was
significantly better for active than for placebo (p <0.001) and
a separation from placebo was seen as early as 30 minutes
post-dosing (p=0.046), indicating a rapid onset of sedation. The
placebo group averaged positive cumulative RASS values once the
local anesthetic/procedure began, indicating an anxious and
restless patient; the patients treated with ARX-03 demonstrated
cumulative negative RASS values throughout the entire procedure,
indicating a calm to mildly sedated patient. These data demonstrate
both the need for a product such as this in the procedural setting,
as well as the efficacy of ARX-03 in providing mild sedation during
surgical procedures.
A key secondary endpoint was the efficacy of ARX-03 in reducing
anxiety compared to placebo. The cumulative anxiety score
(patient-reported 11-point scale) over 4 hours was significantly
lower for active than for placebo (p=0.004), and a separation from
placebo was seen as early as 15 minutes post-dosing (p=0.034),
indicating a rapid onset of anxiolysis. The secondary endpoint of
analgesic efficacy (Summed Pain Intensity) which reflects the
cumulative pain score over the 4-hour study period was lower for
the group treated with ARX-03 relative to those treated with
placebo (median values of 13 versus 23 in the active and placebo
groups, respectively; p=0.09). In addition, both physician and
patient global evaluations of effectiveness and tolerability were
significantly higher in the active versus placebo groups
(p=<0.001 and p=0.028, respectively).
Lead investigator Dr. Neil Singla, commented, "The strong safety
profile and high global satisfaction ratings speak to the
advantages of this product. The blinded Physician Global Efficacy
rating of 'Very Good' or 'Excellent' for 62% of the active patients
versus 5% for the placebo patients demonstrates both the utility
and efficacy of this product. I think this product has exceptional
promise as a routine pre-procedure treatment appropriate for many
different office-based procedures, especially since the discharge
readiness was not different between active and placebo
groups."
Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated,
"There is a growing need for a safe, non-invasive, rapid-acting
medication explicitly developed for use in relieving patients' pain
and anxiety during painful outpatient procedures, such as breast
and prostate biopsies, performed in the clinician office setting.
We are developing ARX-03 to meet this need, and with this first
Phase 2 study we have laid the groundwork by demonstrating that
ARX-03 can be dosed just prior to a procedure and produce safe,
objectively measured mild sedation, along with anxiolysis and
analgesia with rapid onset, that should translate into a meaningful
improvement in both the patient and physician experience."
About Procedural Pain and Anxiety
The number of minimally invasive procedures performed outside of
the typical operating room setting has grown significantly over
recent years. Despite the prevalence of office-based surgical
procedures, most clinics cannot provide appropriate
staffing/monitoring mandated by the Joint Commission on the
Accreditation of Healthcare Organizations (JCAHO) for intravenous
analgesia and sedation, nor do these procedures require this
moderate to deep level of sedation. As a result, patients
undergoing these procedures often receive only local anesthetics
and consequently experience high levels of pain and anxiety.
Ideally, treatment of procedural pain and anxiety minimizes patient
discomfort and agitation, while maintaining patient safety. A
preferred product candidate for treatment of procedural pain and
anxiety is safe and possesses mildly sedative and analgesic
properties, has rapid onset and a sufficient, but short duration of
action, allowing rapid recovery and discharge.
About ARX-03
ARX-03 is designed to provide mild sedation, anxiolysis and
analgesia in a safe, non-invasive formulation that is easy to
administer sublingually in procedural settings and provides rapid
onset of action. ARX-03 is based on the AcelRx's proprietary
NanoTab(TM) dosage form, which enables delivery of the
sufentanil/triazolam combination by the oral transmucosal route,
resulting in high drug bioavailability but significantly lower and
safer peak plasma levels than the intravenous route. AcelRx has
previously reported results of a Phase 1 study demonstrating the
safety, tolerability and pharmacodynamic efficacy of ARX-03 in
healthy volunteers.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals is a privately held pharmaceutical
company dedicated to the development and commercialization of new
therapies for the treatment of pain and other conditions where
there is an unmet need for improved safety and efficacy. The
company applies its proprietary dosage form and delivery
technologies to enhance the safety, therapeutic benefit and
commercial attractiveness of currently approved compounds. For
additional information about AcelRx Pharmaceuticals visit http://www.acelrx.com/.
Source: AcelRx Pharmaceuticals, Inc.
CONTACT: Nigel Ray, MBA, Vice President, Business Development,
AcelRx
Pharmaceuticals, Inc., +1-650-216-3500, info@acelrx.com
Web Site: http://www.acelrx.com/
Posted: October 2009
