- AcelRx Pharmaceuticals received a Complete Response Letter (CRL) from the FDA in response to its new drug application for Zalviso (sufentanil sublingual tablet system).
- The FDA wants additional information about the proper use of Zalviso, as well as additional bench data.
- AcelRx plans to resubmit its application by the end of the year.
Zalviso is the lead product for AcelRx, a company that focuses on pain therapies. Zalviso is intended to improve pain management in hospitalized patients with moderate-to-severe pain by using a pre-programmed, patient-controlled device. The FDA has requested more data to make sure that Zalviso works properly.
Some of the agency's most prominent concerns involve optical system errors and instructions on using the device. AcelRx's new drug application has been partially amended to address some of these issues, but more bench-testing is necessary. Richard King, president and CEO of AcelRx, said, “We are confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."