January 13, 2020

The U.S. FDA has approved Numbrino® (cocaine hydrochloride nasal solution 4%), a nasal spray manufactured by Lanett Company and indicated to provide local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

In clinical trials, Numbrino produced rapid pain relief that lasted throughout nasal procedures. Prior to the product’s approval, Lannett had been marketing unbranded 4% and 10% cocaine topical solutions that, while not FDA-approved, were permitted as they had been in general use prior to certain FDA regulations going into effect.

Recommended dosing ranges from 40mg to 160mg, based on the nasal surface area to be anesthetized and the procedure to be performed. Numbrino is only for use in healthcare facilities equipped to provide secure storage and tracking of controlled substances. A black box warning cautions that central nervous system (CNS) stimulants such as cocaine hydrochloride have a high potential for abuse and dependence. Numbrino is classified as a schedule II controlled substance by the U.S. Drug Enforcement Agency.

Lannett Company plans to launch Numbrino shortly after approval but has not yet announced pricing plans.

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