AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for Zalviso™ (sufentanil sublingual tablets). The opinion, while not binding, recommends marketing authorization for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. Zalviso is an investigational drug-device combination product designed to deliver a sublingual formulation of sufentanil 15 mcg via a proprietary pre-programmed, non-invasive, patient-controlled device. Grunenthal Group, AcelRx's licensee in Europe, submitted the Marketing Authorization Application (MAA) under the centralized procedure in July of 2014.
"We believe that Zalviso represents a significant advancement in the management of acute pain, including the moderate-to-severe acute pain experienced by patients recovering from surgery. With this positive opinion from CHMP, Grunenthal and AcelRx are one step closer to bringing a non-invasive, self-dosing, pain management system to the estimated 15.7 million Europeans who undergo surgeries associated with moderate-to-severe post-operative pain every year," stated Howie Rosen interim chief executive officer of AcelRx Pharmaceuticals. "We appreciate the collaborative approach of the CHMP and look forward to continued collaboration with EMA to complete the regulatory process."
The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union (EU), which has the authority to approve medicines for the 28 member countries of the EU which will also be valid in Norway, Iceland and Liechtenstein. If approved, Grunenthal expects to launch Zalviso beginning in the first half of 2016. In addition, AcelRx would be eligible to receive a $15 million milestone payment from Grunenthal upon approval.
AcelRx had previously received CE Mark approval of the Zalviso device and ISO certification of its quality management system issued by the British Standards Institution, or BSI, a Notified Body. Under the terms of the collaboration, Grunenthal is responsible for all commercial activities for Zalviso, including obtaining and maintaining pharmaceutical product regulatory approval in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory and manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.
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