To combat the problem of increasing death rate in the United States due to opioid overdose, the FDA has approved a generic variant of naloxone.
Naloxone is a drug used to rapidly reverse the effects of an opioid overdose and prevent death. The medication will come in the form of a nasal spray and it will be easily administered by anyone to help a patient who has overdosed.
The first generic naloxone hydrochloride nasal spray, better known as Narcan, is from the Israel-based company Teva Pharmaceuticals.
The FDA Approves First Generic Naloxone Nasal Spray
According to the Centers for Disease Control and Prevention, in 2017, more than 70,000 people died from drug overdoses. About 68 percent of those deaths involved prescription or illicitly-obtained opioid.
The misuse of opioid is a major problem across the country and around the world. In an effort to control the rapidly increasing number of deaths due to opioid overdose, the FDA is adopting new strategies.
"In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible," said Douglas Throckmorton, deputy center director for regulatory programs of FDA's Center for Drug Evaluation and Research.
The first generic naloxone spray can counter the fatal reactions caused by an opioid overdose within minutes after it had been administered. The presence of professional medical personnel is not necessary to administer the treatment, but the FDA added that it is not a substitute for medical care. Even after the naloxone nasal spray is used, the person who administered the medication is advised to immediately bring the patient to the hospital to receive necessary medical care.
Taking high doses of opioids might cause breathing to become shallow or stop completely, leading to death.
Fighting The Opioid Epidemic
Throckmorton also stated that the agency will review additional generic applications for naloxone that will be readily available to the public. The agency has taken the extra step of assisting manufacturers to pursue approval and offer over-the-counter naloxone products immediately to those who might need them.
"All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most — friends and families of opioid users, as well as first responders and community-based organizations," he stated.
"We're taking many steps to improve availability of naloxone products, and we're committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction."