BioCentury
ARTICLE | Company News

Gruenenthal submits Zalviso MAA

July 7, 2014 11:41 PM UTC

Gruenenthal Group (Aachen, Germany) submitted an MAA to EMA for Zalviso to treat moderate to severe acute pain in adults in a medically supervised environment. The submission triggers a $5 million milestone payment to AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX). Gruenenthal has commercialization rights to Zalviso (formerly Sufentanil NanoTab PCA System) in Europe and Australia from AcelRx under a December deal. The pre-programmed, handheld device delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. An NDA is under FDA review, with a July 27 PDUFA date. ...