Requests that the FDA guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in All Settings (Including Non-Medical Settings) by Individuals (Including Non-Medically Trained Individuals)
Citizen Petition CDER 2016-4203 Adapt Pharma Pacific Link Consulting FDA Guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in All Settings (Including Non-Medical Settings) by Individuals (Including Non-Medically Trained Individuals) OPEN
2016-10-17 2016-12-08
FDA-2016-P-2072-0003 FDA-2016-P-2072-0004
04:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2016-P-2072-0003 https://api.regulations.gov/v4/comments/FDA-2016-P-2072-0004
Anonymous Anonymous
Anonymous Anonymous
I support the cause of the petition. Opiate overdoses are a huge issue, and if doctors and pharmaceutical companies are going to enable people by prescribing opiates, there needs to be a better way to prevent deaths when there is an overdose. I support Adapt Pharmaceuticals petition.  As opioid use rises, and pharmaceutical opiates like Fentanyl are becoming prescribed more regularly, first responders need a faster acting, higher strength medication.  According to the Center for Disease Control (CDC), naloxone has been responsible for saving over 10,000 lives between 1996 and 2010.  The lives saved will only increase with the intranasal Narcan becoming more readily available.  A higher dose being available can assist when a person overdoses on a more potent opioid such as Fentanyl.  According to the National Institute on Drug Abuse, by 2014 overdose deaths from prescription opiates had tripled in the last 20 years, with there being nearly 207million opiate prescriptions written in the United States in 2013.Studying the way the product Narcan is delivered is a great idea.  Having a package that is easily opened, then delivered, in its entirety, will ensure that people are getting their full dose quickly. Also, having the package labeling instructions easily understood by teenagers and by illiterate adults just makes sense. These easy to comprehend package instructions will ensure that almost anyone who has a Narcan kit can effectively deliver a dose in a life-saving moment. As the CDC explains, over 165,000 people have died from opioid overdose in the US from 1999 to 2014, today over half of these deaths each year are from prescription opioids. Please process Adapt Pharmaceuticals request, and get started on approval of other forms of Narcan. The more opiates are prescribed, the more the US needs a medication like this available to first responders, and other potential witnesses of a likely opiate overdose. Thank you.Jeremy G.