The approval allows Lannett to move forward with a cocaine hydrochloride nasal solution, as an ester local anesthetic for nasal diagnostic procedures or surgeries.
The US Food and Drug Administration (FDA) approved New Drug Application (NDA) for cocaine hydrochloride (HCI; NUMBRINO) nasal solution 4% (40 mg/mL) under the 505(b)(2) regulatory pathway for use as an anesthetic.
The spray, developed by the Lannett Company, is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membrane for diagnostic procedures or surgeries on and through the nasal cavities for adults.
"We believe the product has the potential to be an excellent option for the labeled indication,” Tim Crew, chief executive officer of Lannett, said in a statement. “We expect to launch the product shortly, under the brand name NUMBRINO.”
The 505(b)(2) NDA submission was based on a pair phase 3, randomized, double-blind, placebo-controlled, multicenter studies involving several hundred patients, as well as a phase 1 pharmacokinetic study.
In the interventional clinical trial, the investigators tested a placebo topical solution against cocaine hydrochloride 4% or 10% as an aesthetic prior to a diagnostic procedure or surgery for 159 patients.
The primary endpoint of the study was analgesic success immediately after application of the study drug, which is sustained throughout the procedure or surgery for each nostril that received the study drug application.
During the procedure or surgery, no further analgesic treatment was required. Patients with a history of controlled substance abuse were excluded from the study.