FDA Approves First Generic Form of Naloxone Opioid Overdose Intervention Nasal Spray

This week the United States Food and Drug Administration announced the first ever approval of a generic version of the overdose intervention Narcan.  Narcan, of course, is the nasally-administered formulation of naloxone. 

If you aren’t aware, naloxone is the first opioid antagonist to successfully—and consistently—stop or reverse the effects of an opioid overdose. The original form—which is injectable—requires administration by a healthcare professional. The nasal spray version—Narcan—has no such requirement.  

According to FDA Center for Drug Evaluation and Research Deputy Center direct for regulatory programs, Dr. Douglas Throckmorton, this approval is only part of the agency’s drive to make this particular drug more readily available around the country.  In fact, the FDA wants to assist manufacturers in their guided pursuit of an over-the-counter version that is approved by the FDA.

Dr. Throckmorton said, “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations.”

Now it is important to note that while this approval is for the first generic version of the nasal spray naloxone, there has already been generic forms of the injected formulations.  However, all these forms are only available in healthcare settings, like hospitals and emergency departments.

But the US Surgeon General released a public health advisory, in 2018, urging more Americans to simply carry naloxone to help address and curb the crisis of opioid abuse across the country. 

Throckmorton goes on to say, “We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

According to data from the United States Centers for Disease Control and Prevention, opioid overdose claimed 400,000 lives between 1999 and 2017.  These numbers alone certainly support the approval of a study from the National Institutes of Health—and a $350 million grant—aimed at cutting overdose deaths by 40 percent in the next three years.