FDA Approves New Injectable Naloxone

By: Marcus J. Hopkins, Policy Consultant

The U.S. Food & Drug Administration (FDA) has approved a new injectable form of naloxone hydrochloride – an antagonist used to reverse the effects of an opioid (House, 2019).
India-based Aurobindo Pharma, Ltd. received approval for its injectable naloxone in early November 2019 from the FDA at a time when certain areas of the U.S. – primarily those located in areas where opioid-related drug overdoses are high – are facing shortages of naloxone (Sharpless, 2019).

Photo Source: NPR

Injectable naloxone, as per FDA requirements, require a prescription for distribution in most states, although some states and pharmacies have suspended that requirement (Marsh, 2018). It is also more difficult for people to administer than the nasal spray version, Narcan, which retails at an average retail price of $140.48 (GoodRX, n.d.). The FDA did, however, approve a generic version of the nasal spray from Israel-based Teva Pharmaceutical Industries, Ltd. in May 2019 (Ducharme, 2019), although Teva has not yet announced their pricing on the generic, nor a street date for its release.

The U.S. continues to see annual increases in drug overdose deaths overwhelmingly driven by opioid-related overdose deaths, primarily heroin and fentanyl, a synthetic opioid drug that has increasingly been finding its way into supplies of heroin, counterfeit prescription drugs, and supplies of other illicit drugs such as methamphetamine. The states with the highest rates of drug overdose deaths – West Virginia, Ohio, Pennsylvania, and Kentucky in particular – have large swaths of the states where there is a convergence of opioid overdose deaths, Injection Drug Use (IDU), infectious disease spread via IDU, and a lack of easy access to medical and healthcare services.

As a result of the increasing rates and incidence of overdose deaths, states and municipalities have responded by authorizing (and in some cases, requiring) that state employees be trained and begin carrying naloxone in their places of employment, including local and state offices, schools, and state buildings. These requirements are put in place in anticipation that, given the widespread rate of opioid addiction, someone may overdose in these buildings at some time and require naloxone administration in an attempt to save their lives.

References:

• Ducharme, J. (2019, April 19). The FDA Just Approved the First Generic Nasal Spray to Reverse Opioid Overdoses. New York City, NY: Time USA, LLC.: Time: Health: Drugs. Retrieved from: https://time.com/5574107/fda-generic-naloxone-nasal-spray/
• GoodRx. (n.d.). Narcan. Santa Monica, CA: GoodRx. Retrieved from: https://www.goodrx.com/narcan
• House, D. W. (2019, November 06). FDA OKs Aurobindo's naloxone for opioid overdose. Ra’anana, Israel. Seeking Alpha: Healthcare. Retrieved from: https://seekingalpha.com/news/3515511-fda-oks-aurobindos-naloxone-opioid-overdos
• Marsh, T. (2018, June 04). Here’s How to Get Naloxone, the Opioid Overdose Antidote, Without a Prescription. Santa Monica, CA: GoodRx: Blog. Retrieved from: https://www.goodrx.com/blog/heres-how-to-get-naloxone-the-opioid-overdose-antidote-without-a-prescription
• Sharpless, N. E. (2019, September 20). Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths. Rockville, MD: U.S Food & Drug Administration: News & Events: FDA Newsroom: Press Announcements. Retrieved from: https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose

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