The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Numbrino (cocaine hydrochloride nasal solution; Lannett) for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
The approval was supported by data from two phase 3, randomized, double-blind, placebo-controlled, multicenter trials (NCT02500836 and NCT01746940) along with a phase 1 pharmacokinetic trial. The application was submitted under the FDA’s 505(b)(2) regulatory pathway, which contains full reports of safety and efficacy data with at least some information that comes from studies not conducted by or for the applicant.
“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, CEO of Lannett. “We believe the product has the potential to be an excellent option for the labeled indication.” The Company plans to launch the product shortly as a 4% nasal solution (40mg/mL).
According to a systematic review evaluating agents used in preparing the nose for diagnostic and therapeutic procedures, cocaine was the most commonly used topical preparation by ear, nose and throat physicians, however it was also associated with more adverse effects.
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