Considerable Details
- The FDA has approved nasal sprays and autoinjectors with 2 mg of naloxone for self-administration.
- However, the body that regulates medicines said it needed more data to decide on OTC products.
- The number of opioid overdose deaths rose by 65% during Covid-19, from 47,000 in 2019 to 78,000 in 2021.
Food and Medicine Administration (FDA)
The Food and Drug Administration (FDA) said that it could approve nasal sprays and autoinjectors that can be purchased over the counter to prevent opioid overdoses.
However, FDA says nasal sprays and autoinjectors containing up to 4 mg of naloxone may be safe and effective for self-administration.
We believe the prescription requirement for naloxone products isn’t necessary for public health,” the FDA said on Tuesday. However, the agency emphasized that it needed more evidence to come to a conclusive judgment about the matter.
During Covid-19, opioid overdose deaths rose by 65%, from 47,000 to 78,000 in 2019 to 2021. Since 1999, more than 564,000 individuals in the United States have died directly from opioids. In three waves, prescription opioids, heroin, and fentanyl cause these fatalities.
Researches
In 2017, President Trump declared an opioid “public health emergency.” Since then, HHS has declared an emergency every three months. In September, the administration of Vice President Joe Biden again extended the emergency declaration.
FDA Director Robert Califf said in a statement that the agency is looking at ways to minimize opioid-related deaths by improving access to naloxone. The FDA urges naloxone drugmakers to apply to make their drugs OTC.
Naloxone is a medication that binds to opioid receptors and quickly reverses the effects of an opioid overdose. NIDA says it can quickly restore normal breathing to someone who has an opiate overdose and is breathing slowly or not.
