Adapt Pharma Commences Rolling NDA Submission to the FDA for Intranasal Naloxone
June 3, 2015
Dublin, Ireland – June 3rd, 2015 – Adapt Pharma Limited (Adapt Pharma) today announced that last month it commenced a rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for a nasal spray formulation of naloxone, a drug intended to treat opioid overdose. A rolling submission allows completed portions of the NDA to be submitted and reviewed by the FDA on an ongoing basis.
Naloxone is approved by the FDA, in injectable formulations, for the emergency treatment of known or suspected opioid overdose. Adapt Pharma is collaborating with the U.S. National Institute on Drug Abuse (NIDA) to develop a nasal spray formulation of naloxone that would be suitable for administration in a non-hospital setting by non-medically trained personnel.
The development program for naloxone nasal spray has been granted Fast Track Designation by the FDA. This designation is to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need.
About Opioid Overdose
The number of opioid overdose related deaths continues to increase. Data from Centers for Disease Control and Prevention (CDC) WONDER database indicates opioid overdose led to the loss of over 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 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 by non-medically trained personnel.
About Adapt Pharma Limited
Adapt Pharma Limited is a privately held pharmaceutical company committed to positively impacting the lives of patients with specialist medical conditions. Adapt Pharma’s strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development, and FDA approved, pharmaceutical products. Adapt Pharma’s company headquarters are in Dublin, Ireland. For more information please visit: www.adaptpharma.com
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