A generic version of the Antidote Naloxone opioid overdose has just been approved by the FDA

Photo: Spencer Platt (Getty Images)

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

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

"In the wake of the opioid crisis, numerous efforts are underway to make this overdose reversal treatment more readily available and more accessible," said Douglas Throckmorton, deputy director of the Centre's regulatory programs center for FDA drug assessment and research. in a statement. "In addition to this endorsement of the first generic naloxone nasal spray, going forward we will prioritize our review of generic naloxone drug applications."

Although naloxone has been out of patent since the 1980s, various companies have patented and obtained FDA approval for several drug delivery versions. Teva's product is the first nasal spray approved for community use without any medical training, for example, but the branded version (Adapt Pharma's Narcan) is already approved for the same use, as is a car version injectable brand (Kaleo & # 39; s Enzio).

These branded products are invariably more expensive than generic ones, and their higher (and growing) list prices have limited the possibility for the forces of order, community groups, hospitals and those living with disorder from opioid use to naloxone stocks.

Kaleo's Enzio, for example, now costs about $ 4,000 for each pack of two, but originally it was only $ 575 when it was approved in 2014. And although the company has often subsidized individual costs patients or private insurers, public tax payers such as the federal government often still have to pay – through taxpayers' money – for this higher wholesale price, and many publicly funded programs consequently get less drugs. According to a recent Senate report, Kaleo's overload over the years has cost the government more than $ 140 million. Faced with bad publicity, Kaleo announced last December that it would release a generic version of Enzio in 2019, with a selling price of $ 178 much lower.

Narcan is much cheaper than Enzio, which costs around $ 130 for a double package. But the generic version of Teva should be even less expensive. For some exaggerated contexts, the actual production cost of a single dose of naloxone does not exceed a few cents and the injectable versions of generic naloxone, although more difficult to use, can cost only about $ 20 (although these prices have increased over time as well ). Companies such as Purdue Pharma, infamous for triggering the opioid crisis through its misleading painkillers, have also tried to enter the antidote market for opioid overdose.

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

In addition to approving generic and less expensive versions of naloxone, the FDA also states that it is working with companies to quickly trace a counter-top version of the drug, which has long been advocated by public health policy experts and opiates.

. (tagToTranslate) Opioid crisis (t) Opioid (t) Drugs (t) Science (t) narcan (t) naloxone (t) Gizmodo


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