AcelRx (ACRX) Initiates Phase III IAP312 Study On Zalviso
Zacks Investment Research | Sep 28, 2016 08:56AM ET
AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) announced that it has initiated a phase III study, IAP312, on Zalviso (sufentanil, 15mg) for the management of moderate-to-severe acute pain in adult patients in a hospital setting. Shares of the company gained 6.4% on the news.
IAP312 is an open-label study, which will enroll hospitalized post-operative patients (n~315) who will self-administer Zalviso sublingually once every 20 minutes through 24 to 72 hours to manage moderate-to-severe acute pain.
The study is being conducted at the request of the FDA’s Division of Anesthesia, Analgesia and Addiction Products.
Note that in Jul 2014, AcelRx received a Complete Response Letter (CRL) from the FDA in response to its New Drug Application (NDA) for Zalviso. The FDA had asked AcelRx to conduct an additional study on Zalviso to assess the risk of inadvertent dispensing and overall risk of dispensing failures.
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