NDA for AcelRx's Zalviso Accepted - Analyst Blog
06 December 2013 - 11:04AM
Zacks
AcelRx Pharma (ACRX) is seeking U.S.
approval for Zalviso for managing moderate-to-severe acute pain in
adults in the hospital setting. The New Drug Application (NDA) was
submitted by the company to the U.S. Food and Drug Administration
(FDA) for Zalviso in the above indication last month.
AcelRx recently announced that its NDA for Zalviso was accepted
by the FDA on Nov 26, 2013. The NDA was submitted on the basis of
encouraging data from two phase III studies – one in patients
following major abdominal surgery and the other in patients
following major joint replacement surgery.
In addition to these studies, a phase III open-label
active-comparator study was also conducted. This study was
conducted in patients who suffered either major abdominal or
orthopedic surgery. The study compared Zalviso to the current
standard of care, intravenous patient-controlled analgesia (IV PCA)
with morphine. Zalviso achieved the primary efficacy endpoints
successfully in each of these studies.
AcelRx expects FDA action in the third quarter of 2014. Assuming
approval at that time, AcelRx expects to launch Zalviso in the
first quarter of 2015.
As per the information provided by the company, around 12
million patients suffer from moderate-to-severe pain during the
surgical procedures in the U.S. per annum.
The main competition for Zalviso is the IV PCA pump, which is
produced by companies like Curlin Medical, Inc. and Smiths Medical.
Potential competitors for Zalviso include IONSYS, developed by
The Medicines Co. (MDCO) and MoxDuo developed by
an Australian company, QRx Pharma.
AcelRx carries a Zacks Rank #3 (Hold). Some better-ranked stocks
include Aeterna Zentaris Inc. (AEZS) and
Jazz Pharmaceuticals plc (JAZZ). Both carry a
Zacks Rank #1 (Strong Buy).
ACELRX PHARMACT (ACRX): Free Stock Analysis Report
AETERNA ZENTARS (AEZS): Free Stock Analysis Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report
MEDICINES CO (MDCO): Free Stock Analysis Report
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