DLNews Health: JTFMax

One of the critical steps to reducing opioid overdose is to make naloxone available to more people. In response, the Food and Drug Administration (FDA) is taking an innovative approach to speed up the development of nonprescription naloxone products. It tests products that may be safe for use without a prescription and develops consumer-friendly labels.

Only a few pharmacies are willing to dispense naloxone without a prescription. For those that do, the product costs can be high, and there is also the fear that pharmacists will discriminate against consumers. Emergent BioSolutions submitted an application to the FDA for over-the-counter Narcan spray. This type of spray is already prefilled and requires no assembly.

The naloxone available today is primarily an injectable drug, but newer nasal spray versions are available at many police stations. There are also several types of naloxone products that are sold at libraries and other public spaces. However, these are considered community-use products and have limited postmarketing experience. Studies indicate that a lack of naloxone in stores and pharmacies has led to an overdose epidemic. According to a survey released by the Delaware Overdose Fatality Commission, naloxone was not dispensed 93 percent of the time.

If an over-the-counter naloxone spray becomes available, the companies that produce and sell it must treat it as a prescription. Then, these companies must submit an application to the FDA, which can fast-track the process. While it has been approved for over-the-counter sale, the price is still relatively high at around $150. Some advocacy groups argue that the price is too high and say it is the government's responsibility to make the medication affordable.

In December, the FDA met to discuss the issue of over-the-counter naloxone. The focus of the meeting was to discuss ways to make naloxone more accessible to more people. Also discussed was a proposal by the Department of Health and Human Services to authorize naloxone sales through bulk orders. Advocacy groups and health officials argue that this could help prevent overdose deaths and that the cost of the Narcan spray is not a reason to prevent people from using the drug.

Another company, Harm Reduction Therapeutics, is working on an over-the-counter naloxone nasal spray. They are receiving funding from Purdue Pharma and plan to apply to the FDA for approval of their product next year. Their goal is to have the product on shelves by 2023. However, several commenters raised concerns about the spray's cost and whether insurance coverage would cover the medication.

As part of its work to promote the safe and appropriate use of naloxone, the FDA is developing a model naloxone DFL for over-the-counter naloxone. Clinicians and addiction treatment experts were consulted to provide feedback. As a result, the information was distilled into critical elements, and a model DFL was developed.

HOW DOES NALOXONE WORK? Just click this link! PART-2