Lightlake Therapeutics Inc, a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced that Adapt Pharma Limited, its partner for treating opioid overdose with intranasal naloxone, has 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 is collaborating with the U.S. National Institute on Drug Abuse (NIDA) to develop a naloxone nasal spray that would be suitable for use in the community setting by non-medically trained personnel.
The development programme 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.
"This is a very important milestone for Adapt and Lightlake," stated Dr. Roger Crystal, M.D., chief executive officer of Lightlake.
"This submission reflects the progress that Adapt has made in advancing the development of this critical treatment. An ease-of-use, needle-free product is urgently needed to help address opioid overdose."
In December 2014, Lightlake announced a licensing deal with a subsidiary of Adapt. In exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $ 55 million, plus up to double-digit royalties.
The number of opioid overdose related deaths continues to increase. Data from Centres 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.