FDA approves Lannett’s cocaine-based nasal spray

pharmafile | January 15, 2020 | News story | Research and Development FDA, Lannett, Numbrino, cocaine 

It has been announced that the FDA has moved to approve Lannett Company’s Numbrino (cocaine hydrochloride) nasal solution for “the introduction of local anaesthesia of the mucous membranes for diagnostic procedures and surgeries”.

The therapy is notable for the presence of cocaine, an illegal, controlled substance which is infamously used recreationally, in its ingredients.  Its numbing properties and ability to prevent bleeding through the constriction of blood vessels can be highly beneficial in delicate operations.

An ester local anaesthetic, Numbrino is to be used in minor surgeries “on or through the nasal cavities of adults”, though it will be marketed to doctors and will not be made available in retail pharmacies.  

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

The positive spike in share value experienced by the company in the wake of the announcement may go some way to reverse the 85% drop it has experienced over the past five years.

Matt Fellows

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