Cocaine nasal spray approved by the FDA

Medical cocaine has been around since it was synthesized at the end of the 19th century. Used at the time as an anaesthetic, it was also recommended for treating respiratory diseases. Its use declined with the advent of modern anesthetics and its classification as a narcotic under the 1961 UN Convention.

In mid-January, however, the FDA approved a cocaine hydrochloride nasal spray, dubbed Numbrino, after two randomized, double-blind Phase III clinical trials.

«FDA approval of our cocaine product, the first to include full clinical trials in the company's history, marks an important milestone in Lannett's 70-year history,» said Tim Crew, CEO of Lannett Company, in an press release. «We believe the product has the potential to be an excellent option for its indication. We plan to launch the product shortly...».

Unlike the cannabis, classified in Schedule I of the Narcotics Control List, the most restrictive, cocaine has been placed in Schedule II, in recognition of the fact that it can be used for medical purposes.

The administration of pharmaceutical cocaine via the nasal route has already been tested in the USA. In the 1980s, Los Angeles-based researcher Ronald K. Siegel studied the effects of cocaine on arthritis pain. The study showed that cocaine could effectively manage chronic pain without triggering an addictive effect. However, patients reported feeling uncomfortable «hitting» a drug, and some study subjects turned to non-pharmaceutical cocaine after Siegel revealed the drug's true identity.

Nasal sprays are particularly used for medical purposes. Last year, President Trump asked the U.S. Department of Veterans Affairs to purchase an FDA-approved ketamine nasal spray (from Johnson & Johnson) to treat depression in veterans. In December, an Oregon-based company announced that she would start developing a nasal spray to administer psilocybin, the psychedelic component of mushrooms.

Nasal sprays for cannabis have already been in existence for several years, but none are FDA-approved.