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The first universal naloxone nasal spray for the treatment of opioid overdose has been approved by the US Food and Drug Administration.

Teva Pharmaceuticals' life-saving product is also the first universal naloxone nasal spray approved for use by people without medical training. There is already a brand name spray (Narcan) for emergency use by untrained people, such as family members and bystanders. urgent need. On average, more than 130 Americans die each day from overuse of opioids-including prescription painkillers such as fentanyl, oxycodone (oxycodone), hydrocodone (Vicodin), and morphine, as well as heroin or sold as heroin Drugs and other illegal drugs, the FDA said. "After the opioid crisis, efforts are underway to make this emergency overdose reversal treatment more accessible and more accessible," said Dr. Douglas Throckmorton, deputy director of the FDA Drug Evaluation Center's regulatory program. In addition to the approval of naloxone nasal sprays, we will give priority to reviewing generic applications of naloxone, "he added.

When someone takes an opioid in excess, breathing may become shallow or stop completely, and death can result if no one intervenes. If given quickly, naloxone can offset this effect in minutes. Throckmorton said in an agency press release that the FDA is also helping drugmakers seek approval for over-the-counter naloxone products and "explore other ways to increase the availability of naloxone products for the community." It is also being considered whether naloxone and all or part of opioids should be prescribed routinely to reduce the risk of overdose. "In summary, these efforts have the potential to be an important tool to help those who are most in need of opioids, as well as first responders and community-based opioid overdose," Throckmorton said. According to the US Centers for Disease Control and Prevention, nearly 400,000 people died of opioid overdose between 1999 and 2017.

"We are committed to working with other federal, state, and local officials across the country, as well as healthcare providers, patients, and communities, to address the huge human and financial costs of opioid abuse and addiction.