FDA Fast Tracks Intranasal Naloxone
The FDA has granted fast track designation to its intranasal naloxone, an opioid antagonist for opioid overdose.
Lightlake Therapeutics and Adapt Pharma Limited announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal naloxone, an opioid antagonist for opioid overdose reversal treatment.
Lightlake in collaboration with the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), initiated a clinical trial with intranasal naloxone in September 2013.
Data from that study showed that using Lightlake's technology naloxone can potentially be delivered into the blood stream at least as quickly as the injection process currently used by hospitals, first responders, and others treating opioid overdoses. The company received an additional commitment from NIDA to fund a second study with respect to Lightlake's nasal spray. On December 4, 2014, Lightlake announced that this second study had commence
In July 2014, Lightlake had filed an investigational New Drug Application (IND) for intranasal naloxone.
For more information visit LightlakeTherapeutics.com.