FDA grants expedited review for over-the-counter Narcan

As the opioid epidemic continues to plague the country, a growing number of companies are submitting applications to the Food and Drug Administration in hopes of gaining over-the-counter approval for their version of an opioid drug. opioid overdose reversal.

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

Early Emerging BioSolutions December announced its nasal spray has won priority review from the FDA to become an “emergency over-the-counter (OTC) treatment for a known or suspected opioid overdose,” the first drug of its kind to receive the review accelerated.

Priority review means the FDA aims to evaluate the submission within a shortened six-month timeframe instead of the usual 10 months for a typical review, and gives designation to drugs that the agency says would “significantly improve treatment, diagnosis or prevention of serious conditions. »

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

Robert G. Kramer, president and CEO of Emergent BioSolutions, wrote in a statement that the company is “committed to increasing access and awareness of naloxone, and we are taking this step to help address to the growing and devastating number of opioid overdoses and deaths that are occurring.” Across the country.”

The accelerated review process would likely put Emergent’s OTC approval ahead of at least one other competitor who has announced plans to submit applications to the FDA and, if approved, would be the first-ever over-the-counter naloxone to be marketed. Emergent expects the FDA review to be complete by March 29, 2023, although that date is not set in stone.

Pocket Naloxone Corp., a start-up that aims to increase widespread access to the overdose reversal drug, in early December announced results from a study of its naloxone nasal swab indicating that it works faster than nasal spray and intramuscular options on the market.

The NaxSwab device, which Pocket Naloxone Corp. CEO and co-founder Ashanthi Mathai said was “in the final stages of development” earlier this month, was designed as an easy-to-use product that Mathai hopes to win over course – Counter FDA approval at some point in the near future.

“We are committed to making it affordable and easily purchasable in retail stores and online as an OTC product,” Mathai wrote in a statement. According The Wall Street JournalPocket Naloxone plans to seek new drug approval early next year and will seek priority approval.

The flurry of requests comes shortly after the FDA issued a notice in November encouraging companies to seek over-the-counter approval for their naloxone products, saying a preliminary assessment found some products may “be approved as safe and effective for non-prescription use. ”

“Today’s action supports our efforts to address the opioid overdose crisis by helping to expand access to naloxone,” FDA Commissioner Robert M. Califf wrote in a statement. . “The agency will maintain overdose prevention and the reduction of substance use disorders as a key priority and an area of ​​intense strategic focus for action as quickly as possible.”

In order to expand over-the-counter access to the overdose reversal drug, the agency said it needed additional information from the companies, including “product-specific data on the design of the drug.” ‘non-prescription user interface, including packaging and labeling’, and more.

The advisory also only applied to certain naloxone products, namely nasal sprays with a dose of up to four milligrams and intramuscular or subcutaneous injections with a dose of up to two. milligrams.

The opioid epidemic has become a growing problem in the United States in recent decades after prescribers began issuing pain management prescriptions for legal opioids like oxycodone, hydrocodone, morphine and more in the late 1990s. In 2010 heroin overdose deaths began to increase dramatically, and in 2013 overdose deaths from synthetic opioids – namely fentanyl – began to rise. increase, according to the Centers for Disease Control and Prevention.

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

About 75,673 people died from an opioid-related overdose in the 12 months to April 2021, compared to 56,064 in the same period a year earlier.

In a call with reporters last weekDirector of the White House Office of National Drug Control Policy, Dr. Rahul Gupta, said the United States had recorded more than 81,000 opioid-related deaths in the past 12 months, adding that “the experience of a non-fatal overdose is one of the strongest predictors of a future fatal overdose.