Lannett announced the 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Topical Solution, 4% and 10%, with a proposed trade name of Numbrino, has been accepted for filing with standard review by the U.S. Food and Drug Administration (FDA). Cocaine HCl Topical Solution is a proprietary local topical anesthetic.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 21, 2018, ten months from the official NDA submission date. The user fee goal date (PDUFA goal date) is the date by which an FDA action is due on a marketing application.
"The FDA's acceptance of the Cocaine HCl Topical Solution NDA is an important step in the FDA review process, indicating that the application is sufficiently complete to permit a substantive review," said Arthur Bedrosian, chief executive officer of Lannett. "Cocaine Hydrochloride Topical Solution represents an opportunity to bring a new local anesthetic to the medical community and patients. We are currently seeking an approval for the product with a nasal indication and, once approved, plan to pursue additional indications. Our market research suggests that the product may have broad applicability across a number of medical specialties, including Ears, Nose and Throat (ENT), Dermatologists, Obstetrics and Gynecology (OB-GYNs), Ophthalmologists, Emergency-Room (ER) physicians, oral surgeons, Proctologists, Veterinarians, Neurologists, Urologists, pain specialists, Oncologists, Hematologists and Podiatrists. “
The 505(b)(2) NDA submission is supported by two Phase III, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase I pharmacokinetic study.