Trials & Filings

AcelRx Files NDA for Zalviso

Pain-treatment system reaches efficacy in Phase III

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

AcelRx Pharmaceuticals, Inc. has submitted an NDA to the FDA for Zalviso sufentanil sublingual microtablet system), a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose as needed for pain control, subject to a 20-minute lockout period between doses. The proposed indication for Zalviso is the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a Phase III registration pr...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters