A Generic Version of Opioid Overdose Antidote Naloxone Just Landed FDA Approval

Illustration for article titled A Generic Version of Opioid Overdose Antidote Naloxone Just Landed FDA Approval
Photo: Spencer Platt (Getty Images)

One of the most important tools for managing the opioid crisis may soon be a lot more available. On Friday, the Food and Drug Administration announced it had granted approval for a generic version of the naloxone nasal spray, a drug used to rapidly reverse potentially fatal opioid overdoses.

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The new generic is by Teva Pharmaceuticals, an Israeli-based company that specializes in generic drugs. The spray will be approved for use by anyone to help with an overdose, regardless of their medical training.

“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,” Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone.”

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Though naloxone has been off-patent since the 1980s, various companies have patented and gotten FDA approval for different versions of drug delivery. Teva’s product is the first naloxone nasal spray generic approved for community use with no medical training, for example, but the brand-name version (Adapt Pharma’s Narcan) is already approved for that same use, as is a branded auto-injectable version (Kaleo’s Enzio).

These brand-name products are invariably more expensive than a generic would be, and their higher (and growing) list prices have limited the ability for law enforcement agencies, community groups, hospitals, and those close to people living with opioid use disorder to easily stock supplies of naloxone.

Kaleo’s Enzio, for instance, now costs around $4,000 per every two-pack, but was originally only $575 when it was approved in 2014. And though the company has often subsidized the cost for individual patients or private insurers, public payers like the federal government often still have to pay—via taxpayer money—for this higher wholesale price, and many publicly funded programs get less of the drug as a result. According to a recent Senate report, Kaleo’s upcharging over the years has cost the government more than $140 million. Faced with the bad publicity, Kaleo announced last December that it would release a generic version of Enzio sometime in 2019, with a much lower retail cost of $178.

Narcan is much cheaper than Enzio, ranging around $130 for a two-pack. But Teva’s generic version should be less expensive still. For some infuriating context, the actual production cost of a single dose of naloxone is no more than a few cents, and generic, though harder to use, injectable versions of naloxone can cost only around $20 (though those prices have risen over time as well). Companies such as Purdue Pharma—infamous for helping spark the opioid crisis via its misleadingly marketed painkillers—have also sought to muscle into the opioid overdose antidote market.

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At this point, Teva has not issued any statement on the expected list price or availability of its product. The company has not immediately responded to a Gizmodo request for more information.

In addition to approving cheaper, generic versions of naloxone, the FDA also says it’s working with companies to fast-track an over-the-counter version of the drug—something public health and opioid policy experts have long advocated for.

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Science writer at Gizmodo and pug aficionado elsewhere

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DISCUSSION

“The spray will be approved for use by anyone to help with an overdose, regardless of their medical training.”

There’s an important word here ... “medical.” While Narcan and its equivalents can be used by someone without medical training, some basic knowledge is required by the person administering the antidote — for his or her own safety. Revived overdose patients don’t peacefully open their eyes like someone waking up from a nap. Instead, they become immediately violent for a short period of time. The rescuer needs to be aware of this and move out of the way.

Still, this is great news.  Hopefully, this lower cost will enable the overdose antidote to be more readily available.  It should certainly help the towns most hard-hit by the opioid crisis that are finding their budgets stretched thin by the costs of Narcan.