Indivior Receives Complete Response Letter from FDA Not Approving Naloxone Nasal Spray New Drug Application for Opioid Overdose11.24.2015 | PDF Version
Slough, UK, November 24, 2015 – Indivior Inc., a subsidiary of Indivior PLC (LON: INDV), today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for naloxone nasal spray, an intranasal naloxone product candidate for the emergency treatment of known or suspected opioid overdose.
The FDA’s response was principally focused on clinical pharmacology that found the early stage uptake of naloxone nasal spray did not fully meet the FDA’s threshold as determined by the reference product (0.4 mg naloxone by intramuscular injection).
Indivior is evaluating the FDA’s comments to determine our next steps to address FDA’s findings.
“We are closely reviewing the FDA’s response,” said Shaun Thaxter, Chief Executive Officer, Indivior PLC. “Our commitment to improving patient outcomes remains steadfast, and as part of this, our work with stakeholders across communities will continue.”
As the rate of opioid prescription painkiller and heroin abuse and dependence has escalated in recent years, so has the number of overdose deaths. Between 1999 and 2013, the total deaths involving opioid pain relievers per year increased fourfold. More than 24,000 people in the United States succumbed to opioid prescription painkiller or heroin overdose in 2013.
To view the full Press Release – Indivior Receives Complete Response Letter from FDA Not Approving Naloxone Nasal Spray New Drug Application for Opioid Overdose