A generic version of the opioid overdose antidote Naloxone Just Landed FDA Approval


Photo: Spencer Platt (Getty Images)

One of the most important tools for managing the opiate crisis may soon be much more available. On Friday, the Food and Drug Administration announced it had approved a generic version of naloxone nasal spray, a drug used to rapidly reverse the overdose of potentially fatal opiates.

The new generic is from Teva Pharmaceuticals, an Israeli company specializing in generic medicines. The spray will be approved for use by anyone to help with an overdose regardless of your medical training.

"Following the opiate crisis, a number of efforts are being made to make this emergency reversal treatment more readily available and more affordable," said Douglas Throckmorton, deputy director of the Center for Regulatory Programs at the FDA's Center for Drug Evaluation and Research . in a statement. "In addition to this approval of the first generic naloxone nasal spray, advancing will prioritize our analysis of generic drug applications for naloxone."

Although naloxone has been patented since the 1980s, several companies have patented and obtained FDA approval for different versions of drug delivery. The product of Teva is the first nasal spray of naloxone approved for community use without medical training, for example, but the brand name version (Adapt Pharma's Narcan) is already approved for the same use, as well as an auto version -injectable brand (Kaleo's Enzio).

These branded products are invariably more expensive than generics, and their higher (and growing) list prices have limited the ability of law enforcement agencies, community groups, hospitals, and people close to people with opioid use disorders of naloxone supplies.

Kaleo's Enzio, for example, now costs about $ 4,000 per package, but originally it was only $ 575 when it was approved in 2014. And although 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 that higher wholesale price, and many publicly funded programs receive 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 bad publicity, Kaleo announced last December it would launch 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 pack of two. But the generic version of Teva still has to be cheaper. For some irritating contexts, the actual cost of producing a single dose of naloxone is only a few cents, and generic, though more difficult to use versions of naloxone may cost only around $ 20 (although these prices have also increased with the time) ). Companies like Purdue Pharma – famous for helping trigger the opioid crisis through deceptively marketed analgesics – also sought to penetrate the market for antidotes for opiate overdose.

At this time, Teva has not issued any statement about the expected list price or the availability of its product. The company did not immediately respond to a request from Gizmodo for more information.

In addition to approving cheaper generic versions of naloxone, the FDA also says it is working with companies to speed up the over-the-counter version of the drug – something that public health experts and opioid policy experts have long argued for.


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