Safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription use; Request for Comments
Safety and effectiveness of certain naloxone hydrochloride drug products for nonprescription Request for Comments CDER FRDTS 2022-446 OPEN
2022-11-17 2022-11-17 2022-11-17 2022-12-22 2022-12-20 2022-12-20 2022-12-29 2023-01-04 2023-01-13 2023-01-13
FDA-2022-N-2673-0003 FDA-2022-N-2673-0002 FDA-2022-N-2673-0004 FDA-2022-N-2673-0071 FDA-2022-N-2673-0066 FDA-2022-N-2673-0067 FDA-2022-N-2673-0075 FDA-2022-N-2673-0077 FDA-2022-N-2673-0100 FDA-2022-N-2673-0126
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https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0003 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0002 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0004 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0071 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0066 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0067 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0075 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0077 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0100 https://api.regulations.gov/v4/comments/FDA-2022-N-2673-0126
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As a licensed HCP I support that all naloxone products should be moved from prescription to OCT status. The FDA choosing not to evaluate all products (even the 8 mg intranasal product KLOXDXADO and the 5 mg ZIMHI) to OTC is beyond perplexing. Move naloxone to OTC NOW!  Komen I am writing to submit my support for nonprescription/over-the-counter access to naloxone formulations across the United States. I am a PhD health researcher whose dissertation focus was on opioid use disorder and harm reduction. Naloxone saves lives, it is as simple as that. Increasing access to naloxone can help reduce overdoses and overdose deaths. Naloxone cannot be used recreationally, and there has been no scientific evidence of significant harm related to naloxone administration that outweighs the risks of opioid overdose.  ZIMHI is an amazing product!  Please allow naloxone to be distributed over the counter! In fact, if there is a way to have it available OTC for free - that would be the best harm reduction our country could provide to our citizens. It is a public health mechanism to save lives. My clinical practice is treating substance use disorders and I get out all the narcan I have. It is the best way to reverse an overdose and it needs to be readily available to everyone. We have decades of experience showing that laypeople with minimal training can successfully use naloxone to save lives. FDA desperately needs to make naloxone available over-the-counter in order to eliminate the myriad bureaucratic barriers that stem from its current status as a prescription-only product. While recent efforts, like the clarification related to the DSCSA, have gone a long way toward making naloxone easier to procure by harm reduction programs, they do not get rid of all hurdles. Additionally, making naloxone OTC would help protect end users who are sometimes harassed by police for having a prescription-only medicine. While I welcome FDAs initiative to encourage sponsors to apply for OTC status for certain formulations and dose strengths, FDAs preliminary assessment unfortunately leaves out the products with the longest track record of community use  0.4 mg/mL intramuscular naloxone. The evidence of success of community naloxone programs is largely built upon the long use of IM product by lay bystanders. These decades of experience show that it is appropriate and safe for community use  especially by people who use drugs who are most often the frontline responders. This product is truly the backbone of the harm reduction naloxone response. And importantly, it is much more affordable than intranasal and autoinjector products. FDA should go further than simply encouraging companies to apply for OTC status for certain IN and autoinjector products. The agency should itself initiate an OTC switch for the widely used IM formulation. Not doing so risks giving the appearance that this critically important formulation is a second-tier product, which will have real implications for the harm reduction programs that rely on it, and for the people who use it. As a public health nurse, I strongly support the availability of over-the-counter naloxone. Naloxone is a life-saving medication that is safe and effective for the reversal of opioid overdose. In fact, naloxone is far safer than many currently available over-the-counter products. Many states allow widespread dispensing of naloxone, which has been shown to be a public health benefit.With increased access, the public would also benefit from widespread education campaigns that explain the signs of opioid overdose, how to respond, and how to access effective treatments for opioid use disorder (of which the gold standard is opioid agonist medications). OTC naloxone may have the added benefit of normalizing carrying naloxone and destigmatizing the use of opioids. While much more is needed to destigmatize drug use and addiction, OTC naloxone would be a small step in this direction. With the increase of synthetic fentanyl and opioid-related deaths across the country, expanding access and eliminating barriers to Narcan is pertinent. I work in patient access in the pharmaceutical industry for an unaffiliated company. I have no ties to this legislation or companies involved other then Im the daughter of a recovering addict. I found my dad cold and blue, from an opioid-overdose. I called 911 and when the paramedics used 4 cans of Naloxone to save his life that night. The paramedics said if they wouldve arrived 15 seconds later, he wouldve died. My dad has overdosed multiple times but this was the closest call and it was directly in front of me. Had I had access to Narcan OTC, I wouldve administered it myself waiting for the paramedics to arrive. A friend lost her boyfriend to an accidental overdose due to synthetic fentanyl being laced. She to found him cold and blue, administered CPR, the paramedics used multiple cans of Narcan and could not revive him. It was simply too late and the fentanyl was too strong. Another family member overdosed on thanksgiving, his friend had a prescription for Narcan, and  administered narcan and saved him on the driveway. I then submitted documents to get him baker acted and on the road to recovery. Addicts do recover, they just need the opportunity to do so and having Naloxone OTC without a prescription provides that opportunity. The proposed switch will expand consumer access and save lives. Personally, I would always keep Narcan in my purse in case anyone needs me to administer it. Increased access to Naloxone is vital to the public.  I support over-the-counter availability of naloxone due to the overwhelming likelihood that the people responding to an overdose will not have had the ability to obtain a prescription. A lifesaving, time-sensitive drug should not be gated behind a doctors prescription, particularly when the people most likely to use it will be recalcitrant to openly admit they are users of illegal drugs.  I support making Naloxone over-the-counter available to anyone who needs this emergency life-saving drug. It is time to arm people, agencies, and drug-users with a tool that prevents loss of life. Make Naloxone OTC!