The number of Americans dying from opioid overdose continues to increase, creating a public health crisis. In 2017, it was estimated that opioids were responsible for more than 47,600 overdose deaths, killing nearly as many Americans as during the entire Vietnam Conflict.
Naloxone is a medicine approved for the treatment of opioid overdose in 1971. Available as an injection, its use was largely confined to hospital emergency rooms. However, over the past two decades, the treatment of opioid overdose has shifted to:
- First responders, including police
- Emergency medical service technicians
- Friends and family of overdose victims
Because many of these individuals are either unable or unwilling to administer an injection, there was a clear need for an alternative to injectable naloxone to quickly and effectively reverse an overdose.
Our Approach to Opioid Overdose Reversal
Recognizing the need for a means of delivering naloxone to overdose victims as quickly and effectively as an injection, Opiant (formerly Lightlake Therapeutics) collaborated with the National Institute on Drug Abuse (part of the National Institutes of Health) to develop a concentrated formulation of naloxone that could be administered intranasally, going from concept to FDA approval in just 3 years.
This product, NARCAN® Nasal Spray, delivers a life-saving dose of the opioid antagonist naloxone with the effective speed of an injection. Packaged as a single-use nasal spray, it can be used with little or no prior training.
Opiant licensed this product to Adapt Pharma (now a part of Emergent BioSolutions) in 2014, and since its approval, it has saved the lives of thousands of overdose victims.
Programs and Progress for Opioid Overdose Reversal
Prompted by an upsurge in opioid overdose deaths driven by fentanyl and related “synthetics,” the National Institutes of Health (NIH) leadership recently called for the development of “…stronger, longer-acting formulations of antagonists.”
We have responded to this call, and are developing an intranasal formulation of nalmefene, a more potent, longer-acting opioid antagonist that is especially well-suited to treat overdose from synthetics.
In a pilot clinical study conducted in collaboration with the National Institute on Drug Abuse (NIDA), nasal nalmefene appeared to have a more rapid onset and longer duration of action compared to naloxone. Based on discussions with the Food and Drug Administration, we will conduct a larger confirmatory study later this year and intend to file a New Drug Application (NDA) for this product in 2020.
This program is fully funded through NDA filing by a grant from NIDA and a contract from the Biological Advanced Research and Development Agency (BARDA).