The OTC naloxone nasal spray from Emergent BioSolutions has received FDA approval.

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The first naloxone medication to be approved for use without a prescription is Narcan, a 4 milligramme (mg) naloxone hydrochloride nasal spray, according to the US Food and Drug Administration (FDA). The conventional treatment for opioid overdose is naloxone, a drug that quickly reverses the effects of an overdose. The decision made today opens the door for the life-saving treatment to reverse an opioid overdose to be sold online and directly to consumers in locations including gas stations, convenience stores, grocery stores, and drug stores. The US FDA granted the OTC approval of Narcan to Emergent BioSolutions.

This OTC product’s producer determines the pricing and availability schedule. When it comes to implementing the Narcan switch from prescription to OTC status, which could take months, the FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products. Only with a prescription will other naloxone doses and formulations be available. With over 101,750 documented fatal overdoses in the 12 months ending in October 2022, drug overdose continues to be a serious public health concern in the United States, with synthetic opioids like illegal fentanyl being the main cause.

“The FDA continues to be dedicated to resolving the complex issues surrounding the overdose pandemic. As part of this effort, the agency has used its regulatory authority to promote expanded access to naloxone by promoting the development of and authorising an over-the-counter naloxone product to address the urgent public health need, according to FDA Commissioner Robert M. Califf, M.D. “Today’s clearance of OTC naloxone nasal spray will increase the number of locations where it is available, enhance access to naloxone, and contribute to a reduction in the number of opioid overdose deaths nationwide. We urge the producer to put accessibility to the product first by making it readily available as quickly as possible and at a reasonable cost.

The FDA originally authorised narcan nasal spray as a prescription medication in 2015. The maker supplied information showing that the drug is safe and effective when used as recommended in its proposed labelling in line with a procedure to convert a drug’s classification from prescription to nonprescription. The drug’s manufacturer also demonstrated that patients may use the medication correctly and safely without a healthcare provider’s guidance. Priority review status for the Narcan nasal spray application was given, and at a meeting of the advisory committee in February 2023, the committee unanimously recommended that the product be allowed to go on sale without a prescription.

The labelling for the presently approved 4 mg generic naloxone nasal spray products that use Narcan as its reference listed drug product will need to be changed in order for OTC Narcan nasal spray to be sold. To convert their items to OTC status, the manufacturers of these goods will need to submit a supplement to their applications. The FDA may make decisions on a case-by-case basis and contact more businesses as necessary, but the approval may also have an impact on the status of other brand-name naloxone nasal spray products containing 4 mg or less. By using Narcan nasal spray on opioid-dependent people, severe opioid withdrawal symptoms like body aches, diarrhoea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, anxiety, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and elevated blood pressure may occur.

According to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, “Naloxone is a key tool in tackling opioid overdoses and today’s clearance reflects the considerable work the agency has undertook to combat the overdose pandemic.” “The FDA is collaborating with our federal partners to help assure ongoing access to all naloxone dosage forms as this product transitions from a prescription-only status to an over-the-counter (OTC) status. Also, we will cooperate with any sponsor looking to market a naloxone product without a prescription, including through a Rx to OTC conversion, and we strongly advise manufacturers to get in touch with the agency as soon as they can to start conversations.

A number of steps have been taken by the FDA to make naloxone products more accessible. The agency invited sponsors to file applications for the approval of OTC naloxone products in November 2022 after making the preliminary determination that several naloxone products, including the one that was finally approved today, may be secure and efficient for use in OTC settings. The organisation earlier declared in 2019 that it has created, tested, and validated a model naloxone Drug Facts Label (DFL) with simple-to-understand pictograms on how to take the medication to encourage manufacturers to pursue approval of OTC naloxone products. In order to evaluate whether all of the product’s components with which a user would interact could be used safely and successfully as intended, a simulated use Human Factors validation study was conducted. The research’s findings were utilised to support the authorised application along with the model DFL.

With the help of the FDA Overdose Prevention Framework, the organisation is still committed to addressing all aspects of substance use, abuse, substance use disorders, overdose, and fatalities in the US. Priorities set forth in the framework include promoting primary prevention by preventing unwarranted initial prescription drug exposure and unwarranted prolonged prescribing, promoting harm reduction through innovation and education, advancing the development of evidence-based treatments for substance use disorders, and safeguarding the general public from illegal, misdirected, or counterfeit drugs that pose overdose risks.    

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