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Home / Health / A generic version of the opioid overdose Antidote Naloxone has just received FDA approval

A generic version of the opioid overdose Antidote Naloxone has just received FDA approval



Photo: Spencer Platt (Getty Images)

One of the key tools to tackle the opioid crisis could soon be more be available. On Friday, the Food and Drug Administration announced that it had granted approval for a generic version of the naloxone nasal spray, a drug used to quickly reverse potentially fatal opioid overdoses.

The new generic comes from the Israeli company Teva Pharmaceuticals, which specializes in generic medicines. The spray is approved for anyone to help overdose regardless of their medical training.

"In the wake of the opioid crisis, a number of efforts are being made to make this emergency overdose treatment more accessible," said Douglas Throckmorton, Deputy Center Director for Regulatory Programs at the FDA's Center for Drug Evaluation and Research. "In addition to the approval of the first generic nasal-spray nasal spray, we will prioritize the review of generic drug applications for naloxone."

Although naloxone has been patent-exempt since the 1980s, several companies have patented the FDA and have obtained approval for various versions of naloxone drug delivery. Teva's product is the first generic naloxone nasal spray approved for use in the community without medical training. However, the branded version (Adapt Pharma's Narcan) is already approved for the same use, as well as a branded version with auto-injection method (Kaleo & # 39; s) Enzio).

These branded products are invariably more expensive than a generic, and their higher (and growing) list prices have limited opportunities for law enforcement agencies, community groups, hospitals, and people living close to people

For example, Kaleos Enzio now costs About US $ 4,000 per pack of two, but was originally only US $ 575 when it was approved in 2014. Individual patient or private insurer costs, public purchasers such as the federal government often still have to pay tax money for this higher wholesale price, and receive many publicly funded programs less money The drug as a result. According to a recent Senate report, Kaleo's appreciation over the years has cost the government more than $ 140 million. Given the poor public, Kaleo announced last December that it will release a generic version of Enzio in 2019 at a significantly lower retail cost of $ 178.

Narcan is much cheaper than Enzio and costs about $ 130. But the generic version of Teva should be even cheaper. For some annoying correlations, the actual production cost of a single dose of naloxone is no more than a few cents. Generic, albeit more difficult to use, injectable versions of Naloxone can only cost about $ 20 (though these prices have also risen over time). Companies like Purdue Pharma – known for launching the opioid crisis with their misleading marketed analgesics – have also sought to develop the antidote market for opioid overdoses.

At this time, Teva has made no information about the expected list price or expected prices of its product availability. The company did not immediately respond to a request from Gizmodo for further information.

In addition to approving cheaper generic versions of Naloxone, the FDA claims that it is working with companies to accelerate an over-the-counter version of the drug, something that has long been advocated by public health and opioid policy experts.


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