If you’re getting a nasal operation in the future, your doctor may be spritzing a little cocaine up your nose.
This month, the Lannett Company Inc. announced that the Food and Drug Administration (FDA) had approved a cocaine nasal spray called Numbrino. Lannett plans to market it to doctors that specialize in the ears, nose, and throat as a local anesthetic during nasal operations.
Founded in 1942, Lannett Company Inc. is a pharmaceutical company that manufactures about 100 generic drugs. Last year, Lannett won a regulatory battle against a competitor that was arguing for a five-year period of exclusivity for its own cocaine hydrochloride product that the FDA had approved two years earlier. The FDA said “Nice try” and allowed Lannett to submit for approval. Numbrino is the Lannett’s first brand-name medication.
Cocaine is in Medicine Already
It’s not exactly news that cocaine is an excellent topical anesthetic. Lidocaine, a chemical cousin of cocaine, is employed as an anesthetic during dental procedures. Why not get the whole family together? Just kidding.
Cocaine is effective because it blocks nerve impulses that result in vasoconstriction and anesthesia. For this reason, cocaine is already being used for procedures that involve the upper respiratory tract. Additionally, cocaine also shrinks the mucous membranes.
Looks like cocaine is making a comeback, but the FDA already acknowledges the medical value of cocaine or else it wouldn’t be classified as a Schedule II substance: illegal for recreational use, fair game for medicine (if appropriate of course).
The Real Question is…Wassup with the FDA?
The FDA is shady, to say the least. According to the Journal of the American Medical Association, the FDA is approving drugs faster than ever. Thus the time they are supposed to take to ensure that the drugs they approve are safe and effective has decreased.
The approval process for Numbrino is quite unclear. Apparently, Numbrino breezed through Phase I and Phase III clinical trials but the FDA approval process normally takes years and years. We know; we’re anxiously waiting for the MDMA clinical trials that are happening right now. Also, what happened to Phase II?
Pharmaceutical companies pay something called “user fees” to gingerly encourage the FDA to expedite the process. The study in the Journal of the American Medical Association estimates that these “user fees” constitute 80% of the salaries of FDA researchers. Whoops.
We’re all about cocaine making a comeback. With the shifting of attitudes towards drugs, especially “scary” ones like cocaine, we could be seeing many more cocaine or coca-based medications in the future. However, we think that all drugs–psychedelics included–should be thoroughly examined before they get put on the market.