The (almost) free drug with which the United States hopes to reduce overdose deaths
More than 200 people die from drug overdoses in the United States every day. Currently available drugs (including one from Pfizer) to reverse opioid overdose are expensive and require a prescription, but a new (or nearly free) spray may be available soon. All the details
In the United States, the Food and Drug Administration (Fda) has granted Harm Reduction Therapeutics, a non-profit pharmaceutical company, the fast track to produce an anti-overdose spray, called RiVive, to be used without a prescription and which can be obtained free of charge or low cost.
Here's what it means and how it works.
THE DECISION OF THE FDA
The FDA announced yesterday that it has accepted the marketing authorization application for the drug RiVive manufactured by Harm Reduction Therapeutics for the emergency treatment of opioid overdose.
RiVive has also obtained Priority Review, or the priority review by the FDA, and the company expects to hear about the approval by April 28, 2023.
THE DRUG
RiVive is a nasal spray based on naloxone, a drug originally approved by the FDA in 1971 as an antidote in cases of opioid overdose. However, it has always remained an expensive product, available only by prescription or through standing order at individual state pharmacies, despite having nearly 99% efficacy and no significant risk of abuse or serious side effects.
As the public health crisis linked precisely to overdose deaths evolves, the FDA has long been encouraging pharmaceutical companies to propose solutions.
Harm Reduction Therapeutics Spray is an intranasal formulation of naloxone (3.0 mg). The company, according to reports from the Wall Street Journal , claims that its drug is three times higher in concentration than administering the same active ingredient with an injection.
COSTS, PRODUCTION AND FINANCING
Naloxone, Quartz writes, is manufactured by Pfizer under the trade name Narcan and ranges in price from about $60 as an injectable to $160 or more for a nasal spray. In 2021, the lack of it drove up prices further, making it difficult for non-profit organizations to get hold of it.
But the naloxone-based drugs currently on the market, as well as having prohibitive prices, also require a prescription. RiVive, on the other hand, in line with the non-profit vocation of Harm Reduction Therapeutics, should not only be much cheaper – the company's goal is to make the drug available at low cost or free of charge – but also purchasable without a prescription.
The WSJ reads that the intention, if approved by the FDA, is to give away a tenth of its product and sell the rest to pharmacies, public sector employees and groups that work with drug addicts at a cost of about $18 a shot. The company expects to produce 2 million doses annually.
Michael Hufford, one of the founders of Harm Reduction Therapeutics, said he has received and continues to receive funding from the now bankrupt Purdue Pharma, maker of OxyContin and target of billion-dollar lawsuits over its role in the opioid crisis .
DEATHS FROM OVERDOSE IN THE UNITED STATES
The United States feels the urgency of making drugs readily available that can reverse the states of unconsciousness and sleep apnea caused by opioids as the number of overdose deaths in the country is increasingly alarming: more than 200 every day , according to the Centers for Disease Control and Prevention (CDC)
In 2021 alone, deaths increased by 15% compared to the previous year and most concerned precisely the abuse of opioids , such as the now well-known fentanyl which, according to the latest provisional data from the CDC, together with other synthetic opioids, was involved in more than two-thirds of overdose deaths.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/il-farmaco-gratuito-o-quasi-con-cui-gli-stati-uniti-sperano-di-ridurre-i-decessi-per-overdose/ on Fri, 30 Dec 2022 14:22:09 +0000.