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MAA submitted for Zalviso

Jul. 07, 2014 8:46 AM ETTalphera, Inc. (TLPH) StockBy: Douglas W. House, SA News Editor
  • AcelRx Pharmaceuticals' (NASDAQ:ACRX) commercialization partner Grunenthal Group submits a Marketing Authorization Application (MAA) to the European Medicines Authority (EMA) for Zalviso, a drug-device combination product for the treatment of moderate-to-severe pain in adult patients. Zalviso ultilizes the opioid agonist sufentanil in a sublingual tablet formulation that is delivered through a pre-programmed non-invasive delivery device.
  • Under the terms of the license agreement, the MAA submission triggers a $5M milestone payment from Grunenthal to AcelRx. It is eligible to receive another $15M if the MAA is approved and up to $200M in subsequent regulatory, product development and net sales targets-related milestone payments plus royalties.

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