AcelRx Pharmaceuticals Inc.’s bid to bring its acute pain treatment Zalviso to the U.S. market has been tripped up by issues with the device for the sufentanil sublingual tablet system.
AcelRx’s Pain Drug Zalviso Delayed By Delivery Device Issues
FDA’s “complete response” letter asks the company to reduce the rate of optical errors and improve the instructions for use of the patient-activated, hand-held analgesic system.