FDA hopes to make opioid overdose medication available without prescriptions
The FDA has announced that it is suggesting drugmakers apply for approval to make some opioid overdose medications available over the counter and without a prescription. It is currently focused on naloxone hydrochloride, which is currently a prescription-only drug, however it can be used to reverse the effects of an opioid overdose.
The opioid antagonist can reverse the impact of opioids such as fentanyl, heroin, oxycodone, codeine, morphine and hydrocodone according to the National Institute of Drugs Abuse (NIDA). The drug attaches to opioid receptors, meaning it can block the potentially fatal symptoms of an opioid overdose, such as slowed or stopped breathing. The FDA has stated that the “prescription requirement for these naloxone products might not be necessary for the protection of the public health.”
The drug is currently available in the form of an auto-injection and a nasal spray. The FDA is suggesting that a nasal spray containing up to 4mg or an auto injection containing up to 2mg could be approved for non-prescription use, however they would need more information before coming to a final decision.
Robert M Califf, FDA commissioner, said, “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone.” He continued to explain that the FDA hopes to keep preventing and reducing substance abuse as a priority in the future. According to a report by the Department of Health and Human Services (HSS), upwards of 760,000 people have died from drug overdose since 1999, and two in every three overdose deaths in 2018 were due to opioids.