AcelRx Pharmaceuticals,
Inc. ACRX, a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced continuing progress on its two
remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in
post-operative pain. The first of those studies in patients after major
abdominal surgery completed the last patient earlier this quarter, and is
expected to provide data later this quarter. The second study, in patients
after major orthopedic surgery, continues to enroll patients, with the last
patient expected to enroll around the end of the first quarter of 2013, and
data expected in the second quarter. A New Drug Application (NDA) submission
for the NanoTab System remains on track for the third quarter of 2013. In
addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for
the treatment of moderate-to-severe acute pain, has completed dosing and
results from this study are expected to be available in the second quarter of
2013.
"We look forward to sharing the top-line results from our abdominal surgery
pain study with our lead product candidate, the Sufentanil NanoTab PCA System,
later this quarter and remain on track for an NDA submission later this year,"
said Richard King, president and chief executive officer of AcelRx.
Status of Ongoing Clinical Trials
o The last patient has completed the Sufentanil NanoTab PCA System Phase 3
double-blind, placebo-controlled post-operative pain study conducted in
patients following open abdominal surgery. The study, initiated in March
2012, enrolled 178 patients at 14 sites. The study is designed to assess
the ability of sufentanil, delivered through the NanoTab System to control
moderate-to-severe post-operative pain over 48 to 72 hours compared to a
placebo delivered through the NanoTab System. The study will also assess
the tolerability, safety, and ease of use of the NanoTab System by nurses
and patients. Top-line results are expected in the first quarter of
2013.
o A second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA
System is being conducted at approximately 32 sites in patients following
hip or knee replacement surgery. Targeting enrollment of approximately
400 patients, dosing of the final subject in this study is expected around
the end of the first quarter of 2013. The primary endpoint for both the
abdominal and orthopedic placebo-controlled Phase 3 studies is the sum of
pain intensity difference to baseline (SPID) over 48 hours. Top-line
results should be available for the orthopedic study during the second
quarter of 2013.
o Dosing of the last patient in a Phase 2, placebo-controlled, dose-finding
study of the Company's ARX-04 sufentanil NanoTab product has completed.
This study, which began in November 2012, enrolled 101 patients following
bunionectomy surgery, randomized into one of three groups: 20 mcg
sufentanil NanoTab, 30 mcg sufentanil NanoTab or placebo. Each dose was
administered by healthcare personnel, as requested by the patient, up to a
maximum of one dose every hour. The study is designed to evaluate the
ability of sufentanil NanoTabs to manage moderate-to-severe acute pain
over the first 12 hours following bunionectomy surgery. ARX-04 is a
sublingual sufentanil product candidate designed to provide a
non-invasive, fast-onset treatment of patients with moderate-to-sever
acute pain, both on the battlefield and in civilian settings of trauma or
injury. AcelRx is conducting the study at two sites with funding provided
by a $5.6 million grant from the U.S. Army Medical Research and Materiel
Command (USAMRMC). Top-line results from the trial are expected during
the second quarter of 2013.
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