FDA Approves Cocaine-Based Nasal Spray
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JANUARY 13, 2020
While using cocaine recreationally remains illegal, the drug does have some use in the medical profession. As it turns out, the Food and Drug Administration (FDA) has approved a nasal spray that contains cocaine as one of its ingredients.
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
Lannett Company (NYSE: LCI), a small-cap drug manufacturer, received FDA approval for Numbrino, the first branded drug in the company’s 78-year history. The nasal spray will be marketed to doctors as a local anesthetic for minor surgeries around the nasal cavities of patients, but will not be available in retail pharmacies.
Image source: Getty Images.
Although cocaine is a Schedule II drug, medical professionals use cocaine for its effectiveness in numbing highly sensitive tissues and constricting blood vessels to prevent bleeding. Ear, nose, and throat surgeons, in particular, find cocaine (also known as cocaine hydrochloride) especially useful when performing operations.
A big win for a small company
This isn’t the first time that the FDA has approved a local anesthetic with cocaine as an ingredient. Back in 2017, another cocaine hydrochloride product called Goprelto was approved by the FDA. It’s similar to Numbrino in that it’s an anesthetic for nasal cavity surgeries.
Although cocaine-based anesthetics tend not to be addictive when employed for a single use by a medical professional, they still need to undergo significant clinical testing before they are approved. Numbrino has also had two phase 3 trials supporting its effectiveness, alongside a separate phase 1 trial.
Shares of Lannett have shot up in response to the news, but the company has still lost around 85% of its market value over the past five years. Time will tell whether Numbrino’s approval could be the start of a comeback for the company.