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FDA Approves Overdose Prevention Drug, Naloxone, Nasal-Spray Version

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The U.S. Food and Drug Administration (FDA) announced that it has officially approved the nasal-spray version of the heroin overdose prevention drug known as naloxone.

Naloxone Nasal Spray

The heroin antidote was originally designed as an injectable. This new form of naloxone (commonly sold as Narcan) is said to be easier to administer as well as less intimating to use during a high anxiety provoking situation.

Naloxone was originally created to help reduce the amount of overdose deaths from heroin that this nation as facing.

“Combating the opioid abuse epidemic is a top priority for the FDA,” stated Stephen Ostroff, M.D., acting FDA commissioner. “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.”

Many medical professionals and advocates have already been using the newer formula of naloxone prior to its FDA approval. A few doctors volunteer their services in a clinic in Kentucky and had multiple kits available with the nasal-spray.

“It’s nice that [the FDA] are catching up with this,” explained Dr. Mina Kalka’s, one of the doctors who has been working with a naloxone clinic.

The FDA acknowledged the issues and released a statement: “There has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.”

The People Advocating Recovery board president, Jason Merrick, stated that the new FDA-approved overdose prevention spray is an important step. The previous version also had to be assembled which could be difficult for some in a crisis.

“It’s all in one contained unit,” he said. “It’s more practical. I hope and pray it will be more affordable.”

Merrick further explained that naloxone was becoming a high demand drug. He had paid only a $1 per kit a few years back. Now, these kits are upward of $50, he says.

Executive director for the North Carolina Harm Reduction Coalition, Robert Childs, also believes that price is an issue. The organization had handed out an estimated 18,680 two-dose naloxone kits. As a result, there were 1,350 overdoses that were prevented and confirmed. Child’s group felt they could have passed out more kits if they were not so expensive.

“The problem is the ability to buy it in bulk,” Child’s said. “Ideally, naloxone would be incredibly cheap.”

Child’s explains that the nasal-spray version of naloxone could be the “game changer for overall access” that they have been waiting for. Right now the kits are being offered to public interest groups at a much cheaper price (around $37.50) than what is currently on the market.

As of now, the nasal-naloxone is not offered over the counter in all states – which Rep. Michael Burgess (R-Texas) feels might help save more lives.

“Right now, it’s hard to get,” Burgess stated. “If it were available at a 24-hour pharmacy, not saying it could save every life at risk, it could save some. The downside of having it available is what?”

At a congressional hearing in April, Burgess brought this to the attention of officials.  Doctors and academics that were part of the hearing’s panelists didn’t disagree. The chief medical officer at Hazelden Betty Ford Foundation, stated that he supports the motion, “We should have over-the-counter naloxone,” he said. “It’s a very innocuous drug.”

Ohio and Kentucky have already passed legislation that allows pharmacies to sell naxolone over the counter. More states may start to pick up this trend as time passes.

Update 12/03/2015: FDA declines the approval of the second nasal version of Naloxone for not meeting the full requirements of the FDA. Indivior, Inc, maker of Naloxone, is reviewing the FDA’s response and working diligently to meet the requirements. Read more: Drugfree.org

Drug Overdose Help

We are grateful that there are drugs out there that can help prevent an overdose death from occurring, but we also know the best defense against an overdose is abstinence from drugs.  If you want to stop abusing drugs, we can help. Contact The Watershed today for more information on how you can stay clean long-term without the obsession and desire to use again.

Addiction Crisis Helpline 24/7: 1-800-861-1768.




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