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AcelRx Pharma (ACRX) Tops Q1 EPS by 1c; Denied Type B Meeting for Zalviso

May 4, 2015 4:06 PM EDT
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Price: $0.86 --0%

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AcelRx Pharma (NASDAQ: ACRX) reported Q1 EPS of ($0.27), $0.01 better than the analyst estimate of ($0.28).

Zalviso Regulatory Update

On April 21, 2015, AcelRx submitted a request to the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP or the Division) of the Food and Drug Administration (FDA) for a Type B meeting. This past Friday the Division notified the Company that the request for a meeting was denied and restated the Division's view that a clinical study is required. We are consulting with our regulatory, legal and clinical advisors to determine our next steps. We will be considering all options to determine a pathway forward for Zalviso including the possibility of dispute resolution through one of the FDA prescribed pathways as well as conducting additional clinical or Human Factors studies.

"As part of the Type B meeting, we intended to share with the Division the results of the bench testing and the Human Factors studies they had requested as part of the CRL and Type A meeting, and further discuss their desire for additional clinical work. We continue to believe that an additional clinical study should not be required to demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase 3 clinical studies, as well as the bench testing and Human Factors studies," stated Howie Rosen interim chief executive officer of AcelRx Pharmaceuticals. "We will provide a further update as to our next steps once we finalize our plan for moving forward towards gaining Zalviso approval in the U.S."

For earnings history and earnings-related data on AcelRx Pharma (ACRX) click here.



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