FDA Greenlights Over The Counter Sale
The U.S. Food and Drug Administration (FDA) has recently approved the first over-the-counter (OTC) nasal spray of naloxone, a medication used to treat opioid overdoses.
This is a significant step towards making life-saving medication more readily accessible to people who are at risk of an opioid overdose.
In the FDA’s press release, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated that “approving safe and effective, easy-to-use, over-the-counter naloxone has the potential to put it in the hands of more people who may be able to save a life.”
The OTC naloxone nasal spray, intended for use by a bystander or caregiver during an opioid overdose emergency, will be available in 4 milligrams and 2 milligrams.
The approval of this OTC medication is a response to the ongoing opioid epidemic in the United States, which has resulted in thousands of deaths each year. According to the Centers for Disease Control and Prevention, over 93,000 Americans died of a drug overdose in 2020, with opioids accounting for most deaths.
A Substance Abuse and Mental Health Services Administration report found that approximately 20% of adults aged 65 and older in the United States have a mental health or substance use disorder.
Substance abuse in long-term care facilities is also a significant issue, with studies indicating that up to 24% of residents have a history of substance abuse, including opioids.
Additionally, a study published in the Journal of the American Medical Association found that more than one in five residents diagnosed with Alzheimer’s disease or other dementia were prescribed opioid painkillers, which could increase their risk of opioid abuse and overdose.
The recent FDA approval of an over-the-counter naloxone nasal spray will benefit long-term care facilities that often care for patients on opioids for chronic pain management, which puts them at a higher risk of accidental overdose.
“With the OTC availability of naloxone, staff members and caregivers can quickly and easily respond to an opioid overdose, potentially saving lives. This new option provides an additional layer of safety and can help ensure a higher quality of care for long-term care residents,” -Joe Kubulak, Chief Operating Officer at SpecialtyRx.