The U.S. Food and Drug Administration (FDA), has approved the first generic Naloxone Hydrochloride nasal spray(Narcan). It is a life-saving medication that can reverse or stop the effects of an opioid overdose. The agency has plans for prioritizing the review of additional generic drug applications for treating opioid overdose. This corresponds with the earlier announced action of helping facilitate an over-the-counter Naloxone product.
Following an opioid crisis, efforts are being made to make the emergency overdose reversal treatment more accessible and readily available. As a result, the FDA has taken the step of helping manufacturers pursue the approval of an over-the-counter Naloxone product. It is also exploring other ways of increasing the availability of Naloxone products. This is according to Douglas Throckmorton who is the M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
This approval is the first generic Naloxone nasal spray to be used in a community setting by people with no medical training. Generic injectable Naloxone products have, however, been available and used for years in the health care setting. Business and other factors may determine how fast the product becomes available. The approval is a vital step for the agency as it works to expand access to the life-saving drug.
Why the treatment is important
As from 1999 to 2017, 400,000 people died as a result of opioid overdose. This is according to the Centers for Disease Control and Prevention. When one overdoses on opioid, it is difficult to make the person fully conscious. Without medical intervention, breathing becomes shallow or completely stops and this could lead to death. Administration of Naloxone nasal spray quickly counters the overdose effects within minutes. However, this is not a substitute for immediate medical care. It is advisable to seek further medical attention.
In April 2017, the U.S. Department of Health and Human Services announced its Point Strategy to fight the Opioid Crisis. Surgeon General VADM Jerome Adams in April 2018 advised those at risk of an opioid overdose to carry Naloxone. The FDA has determined that expanding the availability and access to overdose reversal drugs can help in addressing the public health emergency.
Naloxone nasal spray does not need assembly. It delivers a consistent and well-measured dose when used as per directions for both adults and children respectively. It is sprayed into one’s nostril while the patient lies on their back. For patients who are opioid-dependent, use of Naloxone nasal spray could result in severe opioid withdrawal. On June 8th, 2018, the FDA approved this generic drug product.
FDA. (2019, 04 19). Retrieved 04 24, 2019, from www.fda.gov: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm