Adapt Pharma Limited, a privately held pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Narcan (naloxone) nasal spray, an investigational drug intended to treat opioid overdose.

Narcan nasal spray has been granted Fast Track designation by the FDA. Within 60 days of the submission date, the FDA will determine whether it will accept the application for review as filed. Narcan nasal spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA).

There is a rapidly growing opioid overdose epidemic in communities across America. Centers for Disease Control and Prevention (CDC) data indicates that almost 24,500 lives were lost to opioid overdose in 2013 and 76 per cent of these deaths occurred in a non-medical setting, most frequently at home. Over two thirds of these deaths were due to prescription opioids, a commonly prescribed class of pain medication.

While naloxone has been FDA approved as the standard opioid overdose treatment for almost 45 years, currently all FDA approved formulations are injectable. There is a broad consensus, including the American Medical Association, CDC and the American Public Health Association, supporting expanded distribution and availability of naloxone in community settings, as a key element to address this human tragedy.

Adapt Pharma developed Narcan nasal spray in response to calls for new easy-to-use formulations of naloxone for use in the communities and homes where the majority of overdose related deaths occur.

Seamus Mulligan, chairman and chief executive officer of Adapt Pharma, commented, “If FDA approved, Narcan nasal spray would allow for the administration of naloxone - the standard opioid overdose treatment - in an easy to use, needle-free, nasal spray formulation. We believe this would represent an important new tool to quickly respond to an opioid overdose emergency with this potentially life-saving medicine.”

The number of opioid overdose related deaths continues to increase. Data from CDC WONDER database indicates opioid overdose led to the loss of almost 24,500 lives in America in 2013, a four-fold increase since 1999. Additionally, the Drug Abuse Warning Network (DAWN), a public health surveillance system managed by the Substance Abuse and Mental Health Services Administration (SAMHSA), estimated that in 2011 there were over 740,000 emergency department visits involving the non-medical use of prescription opioids and heroin. With the majority of opioid overdose related deaths occurring in a non-medical setting, there is a need for more user friendly formulations of naloxone suitable for use in the community.