AcelRx’s Pain Drug Zalviso Delayed By Delivery Device Issues

28 Jul 2014

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.

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.

FDA has issued a “complete response” letter on AcelRx’s 505(b)(2) NDA for management of moderate-to-severe pain in hospitalized patients, the...