AEZS Aeterna Zentaris Inc

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).

 
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