The generic-drug manufacturer Lannett Co. Inc. was given approval by the U.S. Food and Drug Administration on Monday to market a branded anesthetic containing cocaine.
Lannett, of Northeast Philadelphia, previously had sold an unapproved cocaine hydrochloride solution, C-Topical, subject to the FDA’s enforcement discretion. The new cocaine pharmaceutical will be sold as a topical solution called Numbrino.
Numbrino, which is the first branded drug in the 78-year-old company’s history, will be marketed to physicians as a local anesthetic for the mucus membranes. It will not be available in retail pharmacies. Numbrino, pronounced “numb-rhino” (rhino means “nose”), will be used for diagnostic procedures or for minor surgery on the nasal cavities of adults.
Cocaine is a Schedule II drug and considered to be highly addictive. But medical specialists — otolaryngologists, for example (a.k.a. ear, nose, and throat surgeons) — value cocaine hydrochloride’s ability to numb highly sensitive tissues and constrict blood vessels.
Lannett’s previous cocaine-based drug had not undergone clinical trials, but the FDA had permitted the company to market the unapproved product.
Numbrino went through rigorous Phase 3 testing, said a company spokesperson. “It is the same product. We now have it FDA-approved and are able to market it as a branded product,” said Robert Jaffe.
The drug almost did not make it to market. Another drug maker, Genus Lifescience of Allentown, had filed a petition with the FDA claiming that Numbrino would infringe on its exclusive right to market its own cocaine product for five years. The FDA ruled against Genus in July.
Lannett employs about 1,020 full-timers and produces about 100 generic drugs.
In December, the FDA gave Lannett the OK to market a generic version of Adderall XR, an amphetamine salt often prescribed for ADHD. The company has largely divested itself of its generic opioids, Jaffe said.
Only five years ago Lannett was heralded by Fortune Magazine as "the “fastest-growing company in the U.S.” and its stock reached an all-time high in April 2015 of $71.15.
During the last five years, the company’s stock — like others in the generic industry — has taken a beating as state attorneys general investigate allegations of widespread price fixing in the generics industry.
Lannett additionally was hit when its supply contract for the thyroid medication Levothyroxine expired last March. The stock, LCI, plummeted in October 2018 to $3.33.
In answer to the setbacks, Lannett CEO Timothy Crew has been aggressively launching new products in an effort to rebuild the company.