FDA Approves Naloxone Nasal Spray

naloxoneThere is little debate regarding the insidious nature of opioid addiction, a scourge that has been tearing American families apart for over a decade. The prescription opioid painkiller epidemic stems from a change in modalities with doctors and how they manage a patient’s pain. Gauging a patient’s pain is no easy task because pain intensity is subjective. Doctors are required to treat a person’s pain adequately, which has resulted in rampant overprescribing and a subsequent rise in addiction rates. After a decade and a half of overprescribing opioids, both federal and state governments had had enough. In more recent years, practically every state implemented prescription drug monitoring programs (PDMP) to track patients who fill multiple prescriptions of the same types of drugs. Before such programs were put in place, patients could visit multiple doctors in a week complaining of the same ailment - giving them the ability to accumulate more pills than any one person could use in a month. The medications, often paid for by state assistance programs, were then resold at inflated prices to those who would abuse the drugs. Government crackdowns on prescription opioid abuse made it more difficult for addicts to acquire drugs, such as oxycodone (OxyContin ®), due to scarcity and heightened pricing. Curbing painkiller abuse had an unintended consequence, addicts left with few options turned to heroin - a cheaper and often more potent substance. In the last decade, heroin use more than doubled among young adults ages 18–25, and 45% of people who used heroin were also addicted to prescription opioids, according to the U.S. Centers for Disease Control and Prevention (CDC). Opioids, whether by prescription or bought on the street in the form of heroin, are not just highly addictive, misuse can result in a fatal overdose. The CDC reports that 44 people die every day from an overdose. Thankfully, if an overdose victim is discovered in time, their life can be spared. The drug naloxone hydrochloride has life saving potential, reversing the effects of a prescription opioid or heroin overdose. Until recently, naloxone was only approved for use in the form of injection by the U.S. Food and Drug Administration (FDA). Naloxone injections, while effective, requires the administrator to be proficient in giving injections - ruling out the majority of people who are first to discover an overdose victim. This week, the FDA announced the approval of a nasal spray version of naloxone, which first responders say is easier to use, according to an FDA news release. Naloxone nasal kits eliminate the risk of a contaminated needle prick. While unapproved, many first responders, such as EMTs and police officers, used naloxone with nasal spray adapters; now, the nasal spray devices will meet the FDA’s high standards for safety, efficacy and quality. What’s more, the nasal spray does not require extensive training to administer, meaning that a mother, father or even child can save the life of a loved one. A number of states and municipalities have lighten the restrictions on who can have access to the life saving drug, hopefully the new approval will convince other states to follow suit. The majority of overdose victims are discovered by a friend or family member. With overdoses, time is of the essence, the sooner naloxone is administered - the greater the chance of saving a life.
Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
___________________________________________________________________________ If you are or a loved one is struggling with prescription opioids or heroin, please contact Pace Recovery Center.

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