FDA Allows Expedited Review of Marketed Narcan

As the opioid epidemic continues to plague the country, more and more companies are submitting applications to the Food and Drug Administration in hopes of gaining over-the-counter approval for versions of opioid overdose reversing drugs. .

The latest such company is Emergent BioSolutions, makers of the widely used nasal spray Narcan.

Early emergent biosolutions Announced in December The nasal spray was granted priority review by the FDA to be an “over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.”

Priority review means that the FDA aims to evaluate submissions in a shortened timeline of six months, compared to the 10 months normally required for review. , or significantly improve prophylaxis”. serious condition. ”

First approved for prescription use by the FDA in 2015, Narcan is an intranasal naloxone hydrochloride spray for suspected opioid overdose.

In a statement, Robert G. Kramer, president and CEO of Emergent BioSolutions, said in a statement that the company is “committed to increasing access and awareness of naloxone, leading to increasing numbers of deaths and devastating opioid overdoses and deaths. We are taking this step to address the numbers. Nationwide.”

Due to the expedited review process, Emergent’s OTC approval is likely to come ahead of at least one other competitor that has announced plans to submit an application to the FDA, and if approved, will be the first company in history to hit the market. It will be the first over-the-counter naloxone. Emergent expects the FDA review to be completed by his March 29, 2023 date, although that date has not been confirmed.

Pocket Naloxone Corp. is a startup aimed at increasing widespread access to overdose recovery medications in early December. published results Studies with naloxone nasal swabs show that it works faster than nasal sprays and intramuscular injections on the market.

The NaxSwab device, which Ashanthi Mathai, CEO and co-founder of Pocket Naloxone Corp. said at the beginning of the month, was “in the final stages of development,” was designed to be an easy-to-use product that Matai expects to exceed. I hope – Opposite approval from FDA at some point in the near future.

“We are committed to making it affordable and convenient to buy as an OTC product in retail stores and online,” Matai said in a statement. wall street journalPocket Naloxone plans to apply for new drug approval early next year and will request priority approval.

The series of filings came shortly after the FDA issued a notice in November encouraging companies to apply for over-the-counter approval of naloxone products. ”

“Today’s action supports our efforts to address the opioid overdose crisis by helping expand access to naloxone,” FDA Commissioner Robert M. Califf said in a statement. I am writing inside. “The agency will maintain overdose prevention and substance use disorder reduction as key priorities and areas of strategic focus to act as quickly as possible.”

To expand over-the-counter access to overdose counteracting drugs, the agency said it would request additional information from companies, including “product-specific data on non-prescription user interface design, including packaging and labels.” I got

This notice also applies to certain naloxone products, namely nasal sprays with doses up to 4 milligrams and intramuscular or subcutaneous injections with doses up to 2 milligrams.

The opioid epidemic has been a serious problem in the United States for decades since prescribers began issuing pain-relieving prescriptions of legal opioids such as oxycodone, hydrocodone, and morphine in the late 1990s. According to the Centers for Disease Control and Prevention, heroin overdose deaths began to rise dramatically in 2010, and overdose deaths from the synthetic opioid, fentanyl, began to surge in 2013.

Opioids are now the leading cause of overdose deaths in the United States, with over 82% of opioid-related overdose deaths involving synthetic opioids.

Approximately 75,673 people died from opioid-related overdoses in the 12 months to April 2021, up from 56,064 in the same period last year.

and phone call with reporter last weekDr. Rahul Gupta, Director of the White House Office of National Drug Control Policy, said the United States has seen more than 81,000 opioid-related deaths in the past 12 months, adding, fatal overdose of