The FDA has approved Adapt Pharma’s Narcan naloxone nasal spray for the treatment of opioid overdoses less than four months after the submission of the company’s NDA. Lightlake Therapeutics licensed the intranasal naloxone to Adapt in December 2014; Adapt submitted the NDA in July 2015; and the application was granted priority review by the FDA in September 2015.
According to Adapt, it will provide Narcan nasal spray to law enforcement, first responders, and other groups at a public interest price of $37.50 per single-use device as part of an agreement with the Clinton Health Matters Initiative.
Adapt Pharma Chairman and CEO Seamus Mulligan commented, “Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families. Narcan nasal spray, a ready-to-use, needle-free device, delivers a 4 mg dose of naloxone in a single 0.1 ml nasal spray. This new device makes naloxone readily available for emergency use by a friend, family member or caregiver, as well as offering an alternative treatment option for first responders and healthcare providers. It gives new hope to those concerned about the potentially fatal effects of opioid overdose.”
FDA Acting Commissioner Stephen Ostroff said, “Combating the opioid abuse epidemic is a top priority for the FDA. We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
Read the Adapt Pharma press release.
Read the FDA press release.
