FDA Fast-Tracks Naloxone Nasal Spray

Lightlake Therapeutics recently announced that the FDA has granted Fast Track designation to Adapt Pharma’s intranasal naloxone, an opioid overdose reversal agent.

In collaboration with the National Institute on Drug Abuse (NIDA), Lightlake conducted a clinical trial to examine the efficacy of naloxone nasal spray. The research team found that naloxone delivered via intranasal route reached patients’ bloodstreams as quickly as naloxone delivered via injection.

“We are very pleased the FDA granted Fast Track designation to Adapt Pharma for the intranasal naloxone treatment to reverse opioid overdose,” said Lightlake CEO Roger Crystal, MD, in a press release. “The decision reflects the critical need for better delivery of and access to naloxone. Too many lives have been lost by opioid overdose and we look forward to this novel technology being available to patients and bystanders in the US.”

According to the US Centers for Disease Control and Prevention, there were 16,651 deaths due to prescription opioid overdose in the United States in 2010, compared with 4030 in 1999.