Over-The-Counter Naloxone Nasal Spray Approved By FDA
In a positive step in the right direction, over-the-counter (OTC) naloxone nasal spray has been approved by the Food and Drug Administration (FDA). As a treatment provider for substance use disorders, Tarzana Treatment Centers (TTC) knows this approval will save lives. Thus, Narcan, the 4 mg naloxone hydrochloride nasal spray for over-the-counter use, is available without a prescription.
The timeline for the availability depends on decisions made by the manufacturer. Moreover, the price of OTC Narcan nasal spray is between the manufacturer and the pharmacies. Although it may take months to make this happen, the FDA plans to focus on increasing the availability of the anti-overdose formulation during this period. Additional formulations and dosages of naloxone will still be available, but by prescription only.
How Narcan Nasal Spray Saves Lives
As an opioid antidote, Narcan nasal spray saves lives by reversing the effects of a deadly overdose. If given in time to an overdose victim, Narcan voids the effects of opioids on the human body. With a single spray, an overdose victim wakes up with a jolt with the opioids canceled out.
Across the country, opioid overdoses are a national health crisis. In the 12 months ending in October 2022, more than 101,750 reported fatal overdoses were reported. Driven primarily by synthetic opioids like fentanyl, these overdoses are a national tragedy. Therefore, making sure Narcan nasal spray is available to the general public makes sense if it saves lives. With Narcan available, an overdose goes from a fatal event to a wake-up call that opens the door to potential recovery.
The FDA Commissioner on Narcan Nasal Spray
According to FDA Commissioner Robert M. Califf, M.D., “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Narcan Nasal Spray was first approved by the FDA in 2015 as a prescription drug. Thus, the over-the-counter version is a game changer. Indeed, it shows the severity of a national crisis. Illegal fentanyl abuse and contamination is a plague that continues killing countless thousands nationwide. However, the results of the use of Narcan nasal spray in individuals who are opioid dependent are severe. Hence, using the overdose antidote results in immediate withdrawals, including body aches, abdominal cramps, increased heart rate, sweating, nausea, shivering or trembling, and overall weakness.
Naloxone Nasal Spray and the Bigger Opioid Strategy
Backed by the Biden-Harris Administration, the FDA considers this approval part of a more extensive process. Detailing the strategy, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, explains, “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
On the front lines of the fentanyl abuse battle, TTC 100% supports the efforts of the FDA. OTC Naloxone nasal spray is a positive step in the right direction. Still, more actions need to be taken to save lives. As a nonprofit leader in SUD treatment, TTC believes in prevention and treatment. By raising awareness of the dangers and educating youth, the prevention of opioid overdoses improves remarkably. Moreover, by providing access to quality SUD treatment services, people in crisis can find the road to recovery.