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news.Adapt Pharma announced that it has obtained a license to the Narcan trademark and acquired the related Narcan (naloxone HCl injection) New Drug Application (NDA).
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Narcan was the first naloxone product approved by the U.S. Food and Drug Administration (FDA) as a treatment for opioid overdose in 1971. Narcan has not been distributed under the brand name since 2009; however, the Narcan trademark retains very high brand recognition.
It is estimated that over the past year, Narcan has been mentioned in media reports and searched on the internet approximately as frequently as naloxone, the generic name for Narcan. This high brand recognition is a valuable tool for public health communications, especially given the imperative to build deeper public awareness of treatment options for opioid overdose.
Adapt Pharma previously announced that it had commenced a rolling submission of an NDA to the FDA for a nasal spray formulation of naloxone, a drug intended to treat opioid overdose.
"Our goal in acquiring Narcan and submitting this name as part of our rolling NDA for naloxone nasal spray is to be able to use a recognized name for our potential new product. To help achieve public health goals, using a familiar name can facilitate acceptance and uptake by physicians, patients and caregivers," said Seamus Mulligan, CEO of Adapt Pharma.
Use of the Narcan name is subject to FDA review and approval.
The number of opioid overdose related deaths continues to increase. Data from the U.S. Centers for Disease Control and Prevention (CDC) WONDER database indicates opioid overdose led to the loss of more than 24,000 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 more than 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 naloxone formulations suitable for use in the community by non-medically trained personnel.