The FDA has approved Archimedes' application for Lazanda, a fentanyl spray for cancer patients with breakthrough pain. The system is already approved in five other countries under the name PecFent. It marks the firm's first U.S. approval.
Lazanda is a fine mist that's sprayed into the nose. Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then absorbed across the mucus membrane and directly into the blood stream, according to a release. The system is designed to deliver rapid relief for breakthrough pain episodes, which come on quickly and last between 30 and 60 minutes. Archimedes is launching Lazanda in the second half of this year along with a Risk Evaluation and Mitigation Strategy program intended to prevent abuse of the drug.
"Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain," CEO Jeffrey Buchalter said in a statement. "Lazanda, which uses our patented PecSys drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain."