“AntiOp, Inc., a Kentucky company says its nasal spray could save the lives of thousands of narcotic pain medication and heroin overdose victims and that the Food and Drug Administration (FDA) has specified the final research requirements necessary for approval of the drug. AntiOp, Inc. says, its naloxone nasal spray could be on the market in about 18 months.
“The FDA has been very encouraging of our approach,” said AntiOp founder and CEO Dr. Daniel Wermeling. “Once we file a new drug application, they plan to complete a priority review of our product, which usually takes about six months.”
Naloxone is already stocked in thousands of emergency rooms, ambulances and post-surgery recovery rooms but in an injectable form. It must be administered intravenously or as a shot into muscle or under the skin. Because many heroin abusers carry hepatitis or the HIV virus, the risk of infection to medical personnel is high. Some emergency responders use atomizers to convert the injectable form of naloxone to a nasal spray. Wermeling and others believe a nasal spray version of naloxone will prove to be effective, safer and easier to administer than the current injection-based approach.”
Source: FortMillTimes.com – September 20, 2013