- AcelRx (ACRX -3.6%) reports that Zalviso commercialization partner Grunenthal GmbH has confirmed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has received the written responses to the Day 120 List of Questions regarding the Marketing Authorization Application (MAA) for Zalviso for the management of moderate-to-severe acute pain in adult patients that was submitted in July. They expect to receive a response from CHMP in Q2.
- The Day 120 List of Questions is the EMA's version of the FDA's Complete Response Letter (CRL). CHMP issues it when there are issues with an MAA that require addressing before it recommends approval by the European Commission.
- The company has struggled to get Zalviso approved. The FDA issued a CRL in July, then notified the company a few weeks ago that it will need to conduct another clinical trial to assess certain safety issues with the dispensing device. In response to the delay, it cut 36% of its workforce.
- Previously: AcelRx gets CRL (July 28, 2014)
- Previously: MAA submitted for Zalviso (July 7, 2014)
- Previously: AcelRx plunges 40% premarket on delay of Zalviso NDA filing (March 9)