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EMA Recommends DZUVEO for Moderate to Severe Pain

Sufentanil tablet planned for NDA by developer AcelRx

A PPM Brief

AcelRx Pharmaceuticals (Redwood City, CA), recently announced1 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has made a positive opinion and recommended the approval of DZUVEO (known as DSUVIA in the US) for the management of acute moderate to severe pain in adults.

DZUVEO (sufentanil sublingual tablet, 30 microgram) is designed to reduce acute moderate-to-severe pain and address dosing errors associated with IV administration with its non-invasive single-dose applicator (SDA). Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia.1

AcelRx anticipates that the decision, now referred to the European Commission, which grants a centralized marketing authorization valid in the 28 countries of the European Union (EU), will be adopted within approximately two to three months. AcelRx is also planning to resubmit a New Drug Application (NDA) for DSUVIA with FDA in the second quarter of 2018.1

"The CHMP positive opinion recognizes the compelling efficacy and safety profile of DZUVEO and is a significant step forward in bringing a novel, non-invasive medicine that could potentially transform the management of moderate to severe acute pain in medically monitored settings for healthcare systems, providers and patients in Europe," Vince Angotti, chief executive officer at AcelRx, said in the company’s press release.

Last updated on: May 1, 2018
Continue Reading:
First Transmucosal Opioid for Treating Moderate to Severe Pain in a Medical Setting Enters Path to Approval
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