FDA Approves Cocaine Nasal Spray

By Pat Anson, PNN Editor

FDA advisory committees have taken a dim view of opioid medications recently, soundly rejecting new drug applications for the “opioid of the future” oxycodegol and a new extended-release version of oxycodone.

There was also a split 13-13 vote on a relatively mild opioid painkiller – a combination of tramadol and the anti-inflammatory drug Celebrex..

Advisory committee recommendations are not binding on the FDA, but the votes reflect a growing reluctance to approve any new medication that may worsen the so-called opioid epidemic.

"We can't approve a drug in the midst of a public health crisis," said advisory committee member Steve Meisel, PharmD, who voted no on oxycodegol.

FDA advisors may be rejecting opioids out of hand, but cocaine is a different story. The agency this month quietly approved a nasal solution containing cocaine hydrochloride (HCI) for use as a local anesthetic. The nasal spray, made by the Lannet Company, is intended to relieve pain in mucous membranes during surgeries and procedures in the nasal cavities of adults.

"The FDA's approval of our Cocaine HCl product, the first NDA approval to include full clinical trials in the company's history, marks a major milestone in Lannett's 70+ years of operations," said Tim Crew, chief executive officer of Lannett in a news release.

"We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name Numbrino."

Numb-rino. Get it?

While cocaine is well-known as a drug of abuse, it is classified by the DEA as a Schedule II controlled substance, alongside hydrocodone and oxycodone. Cocaine’s use in medicine is not unheard of. It was commonly used as an alternative to morphine in the last half of the 19th Century until it fell out favor because of high rates of addiction.

Numbrino is not the first nasal spray containing cocaine to be approved by the FDA. In 2017, the agency approved the nasal solution Goprelto, which is also intended for use during surgeries and procedures in nasal cavities. 

Nevertheless, the FDA’s approval of a drug containing cocaine was so unusual that Snopes conducted a fact check to see if it was true. An FDA spokesperson confirmed to Snopes that Numbrino was approved, along with warning labels and other safeguards to discourage its abuse.

“Cocaine hydrochloride nasal solution contains cocaine, a Schedule II substance with a high potential for abuse. However, when used according to the directions provided in the labeling, physical dependence and withdrawal symptoms are unlikely to develop because this drug is for single use during diagnostic procedures and surgeries,” the FDA said.

“To minimize these risks, the labeling suggests that health care facilities using the drug implement effective accounting procedures, in addition to routine procedures for handling controlled substances. Notably, this will be used as an anesthetic by trained health care professionals during diagnostic procedures and surgeries, not by patients directly. It is not available by prescription.”

Numbrino was approved without any of the controversy that surrounds opioid painkillers. In 2018, the FDA’s approval of Dsuvia — a single use opioid intended for severely wounded soldiers and trauma patients — was panned by critics, who called the drug a “dangerously unnecessary opioid medication." Like Numbrino, Dsuvia is not available by prescription and can only be administered by a healthcare professional.