FDA officials are considering whether naloxone should be more widely available beyond medical settings, including through over-the-counter (OTC) sales and/or an intranasal version of the drug.
“Certainly, considering naloxone as an over-the-counter drug is forging new territory,” said Andrea Leonard-Segal, MD, director, FDA Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products. Classifying the drug OTC would probably be accomplished through the new drug application (NDA) process, she said. To accomplish it by FDA rulemaking would take years. The NDA process for switching to OTC classification, she said, would require a fresh look at the drug’s chemistry, pharmacology/toxicology, microbiology, and clinical pharmacology. There might not be a need for efficacy data if a current formulation were used, she said.
Source: DrugTopics.com – May 15, 2012