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FDA supports development of over-the-counter naloxone


FDA supports development of over-the-counter naloxone

By Dr. Jessica Badichek, PharmD

A recent statement from FDA Commissioner Dr. Scott Gottlieb summarized the FDA’s new efforts in encouraging drug manufacturers to develop an over-the-counter version of naloxone, the opioid overdose treatment. The FDA stated that the number of overdose deaths involving prescription and illicit opioids has more than doubled over the last seven years to an estimated 48,000 in 2017. Therefore, the need for greater access to naloxone to reverse overdoses and reduce harm is critical.

Currently, naloxone is available by prescription by a qualified healthcare provider and without a prescription as dispensed by a trained pharmacist in many states. However, offering an over-the-counter version of naloxone may further increase access as many patients may not have a prescriber or may be deterred from seeking help due to the stigmas associated with addiction and substance abuse. The FDA’s statement further indicates that an over-the-counter option would advance public health.

Additionally, the FDA also developed a model Drug Facts Label (DFL) for over-the-counter instructions for use. This was noted to be the first time the FDA has ever done this for a prospective over-the-counter drug. The FDA tested two models, one for a nasal spray and one for an avuto-injector. Both models were well understood by consumers tested and deemed as acceptable for use by manufacturers. The development of this type of labeling and testing to ensure easy to read instructions is one of the major steps required when a drug company brings their over-the-counter drug to the FDA for approval. Therefore, the FDA is strongly encouraging drug makers to develop this product.

It is now up to drug manufacturers to take this encouragement from the FDA and help the public receive greater access to naloxone. This could be a major step in the right direction to save lives and prevent further harm from the opioid crisis in America.

Help & Resources:
CDC Guide to Opioids
SAMHSA Treatment Near You
FDA Disposal of Unused Medications

Important Information: The information contained in this blog is meant for INFORMATIONAL PURPOSES ONLY. This information is not individual medical advice and does not substitute for the advice of your healthcare professional. Always ask your physician or healthcare professional for complete information regarding your care.

About the Author:
Dr. Jessica Badichek is the Director of Clinical Operations at CompreCareRx. With extensive knowledge of psychiatric therapeutics, substance use disorder therapies and pharmaceutical compounding, she is dedicated to providing optimal clinical care policies that focus on the needs of every individual patient. She has a passion for caring for those suffering from addiction and seeks to provide superior clinical care. She holds a Doctor of Pharmacy degree from Philadelphia College of Pharmacy and is a registered pharmacist.