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The first generic spray for naloxone has been approved by the FDA. This decision is a response to the growing number of people who died as a result of an opioid overdose in the United States. ( pixabay )
To combat the problem of increasing the death rate in the United States due to an opioid overdose, the FDA has approved a generic variant of naloxone.
Naloxone is a drug used to quickly reverse the effects of an overdose of opioids and prevent death. The drug will come in the form of a nasal spray and it will be easily administered by anyone to help a patient who has taken an overdose.
The first generic aerosol for naloxone hydrochloride, better known as Narcan, comes from Israel-based Teva Pharmaceuticals.
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 an overdose. Approximately 68% of these deaths involved opioids obtained by prescription or obtained illegally.
Opioid abuse is a major problem throughout the country and in the world. In an effort to control the growing number of deaths due to an opioid overdose, the FDA is adopting new strategies.
"Following the opioid crisis, several efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible," said Douglas Throckmorton, Deputy Director of the Center's Regulatory Programs. for Drug Evaluation and Research of the FDA.
The first generic naloxone spray can counter the fatal reactions caused by an overdose of opioids a few minutes after its administration. The presence of professional medical staff is not necessary to administer the treatment, but the FDA added that it can not be a substitute for medical care. Even after using the Naloxone Nasal Spray, it is recommended that the person who administered the medication immediately bring the patient to the hospital to receive the necessary medical care.
Taking large doses of opioids may result in shallow breathing or complete interruption of breathing, resulting in death.
Fight the epidemic of opioids
Throckmorton also said that the agency would review other generic applications for naloxone that would be easily accessible to the public. The agency took the additional step of helping manufacturers obtain a license and immediately offer naloxone over-the-counter products to those who may need them.
"Together, these efforts could be an essential tool in the fight against opioid overdose in the hands of those who need it most – the friends and families of opioid users, as well as the first ones. stakeholders and community organizations, "he said.
"We are taking many steps to improve the availability of naloxone products and we are committed to working with other federal, regional and local officials, as well as with health care providers, patients and patients. and communities across the country to combat the high human and economic toll created by opioid abuse and addiction. "
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