FDA approved Narcan nasal spray, which is the first FDA approved formulation of naloxone hydrochloride nasal spray. This medicine can save lives and can prevent or reverse the effects of opioid overdose. Opioids are a series of drugs, including prescription drugs such as oxycodone, hydrocodone, and morphine, as well as illegal drugs such as heroin.
Excessive drug-induced death is largely caused by excessive prescription medication. At present, in the United States, the amount of drug lead to death has far exceeded the number of deaths caused by motor vehicle accidents. In 2013, the Centers for Disease Control and Prevention reported a steady increase in the number of overdose deaths, far more than in the past decade. When someone overdoses opioids, it may be difficult to awaken people, breathing may be lighter or stop, and if there is no medical intervention, will lead to death. If naloxone is used quickly, it is usually within two minutes to counter the effects of overdose.
Stephen Ostroff, MD, executive director of the FDA, said: “Combating opioid abuse is still the primary task of the FDA, but we can not do anything when Americans are dying, although naloxone does not solve the current opioid The potential problems with drugs, but we will speed up the review and eventually find new drugs that can save lives, new prescriptions. ”
Until this approval, naloxone is approved only in the form of injections, usually via syringes or automatic syringes. Many first aid and primary caregivers consider nasal spray formulations to be easily delivered and eliminate the risk of contaminated needles. Thus, unapproved naloxone kits (naloxone injection formulations can provide naloxone nasal atomizer), has been widely used. Now, people use FDA approved products, and this drug and its equipment to meet the FDA’s safety, effectiveness of the quality standards.
Narcan nasal sprays do not need to be concentrated and provide consistent, standard dose guidance. This prescription product can be used in adults or children and can easily be used by anyone, even those without medical training. This medicine is injected into the nostrils, although the patient lies and can be repeated if necessary. However, it is worth noting that it is not an alternative to providing emergency medical services, and those who use Narcan nasal sprays should seek immediate medical attention.
FDA grants Narcan nasal spray the ability to quickly track and prioritize. Fast track is a process designed to promote the development and speeding up of drugs to treat serious conditional reviews and to demonstrate the potential for unsatisfactory medical needs. The priority review of the body provides a diagnostic, prevention, or more severe disease diagnosis for the rapid review or effectiveness of drugs that provide a significant improvement in safety. Narcan nasal sprays were approved in less than four months, far exceeding the target date for prescription drug user fees, January 20, -2016.
Narcan nasal spray clinical trial data provided a basis for approval, the drug used in nasal spray administration and FDA approved naloxone intramuscular injection of a dose can reach approximately the same level or high as FDA approved naloxone intramuscular Injection of a single dose of naloxone, and equilibration at about the same time.
Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at FDA, said: “We hear the public’s call to appeal to the use of this drug and we are pleased to be able to reach the drug quickly and we are confident that it will always be like this An emergency life – saving drug.
The National Agency for Drug Abuse (NIDA) plays an important role in the development of Narcan nasal sprays by designing and conducting clinical trials to determine the use of nasal sprays as quickly and effectively as effective injections of Narcan.
“This easy-to-use nasal spray will undoubtedly save the lives of many people, even though prevention is the ultimate goal, but the development of this drug has been successful,” said Nora Volkow, MD, director of the National Institute for Drug Abuse at the National Institutes of Health. In the face of national crisis, scientific public and private together play an important role.
In March, Sylvia M. Burwell, Secretary General of Human Health and Health Services, presented opium abuse and life saving, with the increasing access to and use of naloxone as part of the target strategy. In July, addiction and advocacy groups appealed to naloxone to use the scope of the FDA-sponsored public seminar to take the voices.
The use of Narcan nasal sprays may cause severe opioid withdrawal, such as body pain, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (hair upright), sweating , Yawn, nausea or vomiting, nervousness, irritability or excitability, chills or tremors, abdominal cramps, weakness, and elevated blood pressure.
Narcan nasal sprays are marketed by Adapt Pharma Pharmaceuticals, Inc., Radnor, Pennsylvania.