Acceptance for filing of a new drug application means that the FDA has found the company's submission to be sufficiently complete to review. The agency usually makes a decision regarding marketing clearance of a product candidate within 10 months of the date of its submission.
“Based upon the positive clinical efficacy and safety data observed to date from phase II clinical studies of Zingo in adults, we are actively continuing the development of this product with the initiation of a phase III trial in adults later this quarter,” said John McLaughlin, chief executive officer of Anesiva.
Data from two phase III studies that serve as the foundation of the new drug application, demonstrated that Zingo provided pain relief in children undergoing venous access procedures such as intravenous line placements.
These data, which achieved statistical significance, also showed that Zingo provided pain reduction when given one to three minutes prior to the venous access procedure. Zingo was shown to be well tolerated in these studies.