Officials with the FDA have approved Lannett Company's New Drug Application for cocaine hydrochloride (HCI) nasal solution, 4% (Numbrino).

The nasal solution is a local anesthetic indicated for mucous membranes with diagnostic procedures and surgeries, on or through the naval cavities of adults, according to Lannett.

The NDA submission was supported by a pair of phase 3, placebo-controlled, multicenter studies in several patients, as well as a phase 1 pharmacokinetic study.


Lannett announces FDA approval of NDA for branded anesthetic product, cocaine hydrochloride nasal solution, 4% [news release]. Philadelphia, PA; Lannett: January 13, 2020. Accessed January 14, 2020.