Indivior PLC, a global specialty pharmaceutical company, announced that its New Drug Application (NDA) for naloxone nasal spray was accepted and received Priority Review by the US Food and Drug Administration (FDA) for the treatment of opioid overdose.
This naloxone nasal spray comes as a pre-filled device that contains naloxone specially formulated for optimal absorption into the nasal mucosa. The device has been designed to require minimal training so individuals may be better equipped to help an opioid overdose victim.
Naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the United States. Naloxone nasal spray is designed to deliver naloxone through the nasal mucosa of an overdose victim.
Naloxone, which is an opioid receptor agonist that effectively binds to the opioid receptors in the brain to reverse the effects of natural and synthetic opioids, is the standard treatment for an opioid overdose. Currently, only needle-based formulations of naloxone are FDA approved.
The number of unintentional overdose deaths involving opioid pain relievers in the United States has increased four-fold between 1999 and 2009. Opioid and heroin overdoses cause more than 25,000 deaths in the U.S. every year. Between 50 per cent to 80 per cent of patients who died from a prescription opioid overdose had a history of chronic pain.
“As the rate of opioid overdoses and their profound impact on communities nationwide continues to rise, naloxone nasal spray may help make every life-saving second count by potentially allowing anyone—be they layperson, trained healthcare personnel or first responders—to administer treatment at the scene of an overdose,” said Tim Baxter, M.D., chief medical officer at Indivior. “We look forward to continuing to work closely with the FDA through the review process to make this vital treatment option widely available.”
The FDA’s Priority Review status accelerates the review time from 10 to 6 months from the day of NDA acceptance and is given to medications that may offer significant advances in treatment effectiveness or may provide a treatment where no adequate therapy exists. At this time, the FDA’s response to the NDA for naloxone nasal spray is expected late in the fourth quarter of 2015.
In addition to creating the feeling of euphoria that drug users seek, opioids cause sedation and slowed breathing. When taken in large doses, opioids can cause breathing to stop, resulting in a fatal overdose. Prescription opioids cause more overdose deaths than all other drugs combined, including heroin and cocaine.