The FDA stated that it is planning new steps to prioritize reviewing additional generic drug applications to treat opioid overdose, along with the previously announced action, to help provide over-the-counter naloxone product.
This is claimed to be the approval of first generic naloxone nasal spray to be used in community setting by individuals without medical training. Generic injectable naloxone products have been available for several years.
FDA’s Center for Drug Evaluation and Researchregulatory programs deputy center director Douglas Throckmorton said: “In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible.
“In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone.
“The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.
“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.
“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.”
The agency had previously approved a brand-name naloxone nasal spray and an auto-injector to be used by those without medical training. The present approval is claimed to be an important step, as FDA is working towards expanding access to the life-saving drug.
According to the Centers for Disease Control and Prevention (CDC), nearly 400,000 people died from opioid overdose between 1999 and 2017 and on average, more than 130 Americans die every day from overdose of opioids.
Opioids are a class of drugs that include fentanyl, oxycodone, hydrocodone and morphine, as well as illegal drugs such as heroin or drugs sold as heroin.
Drugs such as heroin usually contain fentanyl or derivatives of fentanyl. In cases of an opioid overdose, it can be difficult to revive the person to full consciousness. Breathing may become shallow or stop completely, leading to death without medical intervention.
When naloxone nasal spray is administered quickly, it can counter the overdose effects, within minutes. However, this treatment is not a substitute for immediate medical care and the person administering the nasal spray should seek further immediate medical attention on the patient’s behalf, the FDA said.
