AcelRx slumps as FDA demands another Zalviso trial
This article was originally published in Scrip
Executive Summary
AcelRx Pharmaceuticals saw its share price slump on news that the US FDA now wants an additional clinical trial conducted "to assess the risk of inadvertent dispensing and overall risk of dispensing failures" of Zalviso, said the Redwood City, CA-based firm. Zalviso is a pre-programmed, non-invasive, handheld system, which delivers 15mcg per dose as needed of sufentanil, an opioid, allowing hospital patients to self-dose in managing their pain. Last July, in a surprise move, the FDA rejected Zalviso's NDA. However, the complete response letter did not mention the need for additional clinical data. AcelRx now plans to meet with the FDA to clarify the situation and discuss the potential design and objectives of new study. An NDA resubmission for Zalviso will not happen this quarter, as previously planned. AcelRx will provide an update on the timing of the resubmission of the Zalviso NDA after meeting with the FDA, it said.
AcelRx Pharmaceuticals saw its share price slump on news that the US FDA now wants an additional clinical trial conducted "to assess the risk of inadvertent dispensing and overall risk of dispensing failures" of Zalviso, said the Redwood City, CA-based firm. Zalviso is a pre-programmed, non-invasive, handheld system, which delivers 15mcg per dose as needed of sufentanil, an opioid, allowing hospital patients to self-dose in managing their pain. Last July, in a surprise move, the FDA rejected Zalviso's NDA. However, the complete response letter did not mention the need for additional clinical data. AcelRx now plans to meet with the FDA to clarify the situation and discuss the potential design and objectives of new study. An NDA resubmission for Zalviso will not happen this quarter, as previously planned. AcelRx will provide an update on the timing of the resubmission of the Zalviso NDA after meeting with the FDA, it said.
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