AntiOp Release: FDA Designates Opioid Overdose Treatment For Fast Track Development Program
7/14/2014 10:29:21 AM
LEXINGTON, Ky.--(BUSINESS WIRE)--A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).
The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as “rolling submission,” whereby AntiOp may submit portions of the new drug application (NDA) in a staged NDA submission process.
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