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Weekly Mass Torts Bulletin 2023-August-14

Antibody Created To Neutralize Deadly Opioid Overdoses

According to preclinical experiments, scientists created an antibody that has a great chance of undoing the fatal consequences of a carfentanil overdose.

A lot of overdoses occur because carfentanil, a strong variation of the synthetic opioid fentanyl, is frequently combined with illegal substances. This recently developed antibody successfully reverses carfentanil-induced respiratory depression in rats by binding strongly to carfentanil, fentanyl, and other variations.

In comparison to existing approaches, the finding shows potential for a more effective, long-lasting therapy for synthetic opioid overdoses.

It has been demonstrated that the novel antibody can prevent respiratory depression, a typical lethal consequence of opiate overdoses brought on by carfentanil, the deadliest fentanyl analogue. Due to its strong affinity for fentanyl and its derivatives and tendency to linger in the body, the medication, which is given by a straightforward intramuscular injection, may provide long-term protection. This month will see the start of FDA-approved clinical studies for the IgG variant of this antibody, CSX-1004, to see how well it works to prevent fentanyl overdoses.

They demonstrated in animals that the most harmful of the variations, carfentanil, can produce a potentially fatal respiratory depression that can be reversed by providing an antibody solution soon after an overdose. According to the findings, compared to currently available treatments for synthetic opioid overdose, the antibody may be more effective and persist longer.

Mu-opioid receptors are neuronal receptors that opioid medications, whether they are synthetic or derived from the opium poppy, bind to and activate. Because these receptors are found on several kinds of neurons throughout the human nervous system, opioid medicines have a variety of effects, including pain alleviation and pleasure as well as respiratory depression, which causes slower and shallower breathing.

The immediate cause of death in the tens of thousands of fatal opioid overdoses that take place each year in the United States is respiratory depression. After fentanyl, carfentanil is the synthetic opioid that is most frequently discovered in illegal substances in the United States. The FDA removed it from the market in 2018 due to its potential for abuse and its probable fatality at dosages measured in micrograms. It was once lawful and used as a tranquillizer for big animals.

The mu-opioid receptor blockers naloxone and naltrexone are currently used to treat overdoses of fentanyl and carfentanil, however even at high dosages, these therapies are occasionally ineffective against synthetic opioids.

 

Study: 1 In 5 Adults With Opioid Addiction Get Treatment

Evidence-based treatments for substance use continued to be gravely underutilized as opioid overdose fatalities in the United States hit record highs, a new study showed.

Opioids account for the great majority of drug overdose deaths, and their prevalence has increased recently. According to figures from the US Centres for Disease Control and Prevention, overdoses involving opioids claimed the lives of over 80,000 individuals in 2021.

However, a recent study by researchers at the National Institute on Drug Abuse and the National Centre for Injury Prevention found that only about a third of adults with opioid use disorder received any kind of treatment for substance use, and only about 1 in 5 received medication to treat opioid use disorder.

A number of medications, including buprenorphine, methadone, and naltrexone, have been licenced by the US Food and Drug Administration to treat opioid use disorder, which affects an estimated 2.5 million individuals in the US. These medications can aid with cravings for opiates or block their effects.

The drugs used to treat opioid use disorder are secure and efficient. The head of the National Institute on Drug Abuse indicated that they support rehabilitation and help avoid overdose deaths. For those who are not receiving evidence-based treatment, failing to use safe and life-saving drugs is distressing. It exacerbates health inequities in local communities across the nation, prolongs the overdose catastrophe, and sustains opioid use disorder. The study also discovered significant differences in who received treatment for opioid use disorder.

When it came to receiving medication to treat their opioid use disorder, males were six times more likely than women to do so. Adults without jobs and residents in rural regions were also less likely to get the drug.

The US Drug Enforcement Administration provided flexibility during the Covid-19 outbreak, enabling the prescription of some prohibited drugs, particularly those needed to treat opiate addiction disorder, over telemedicine. Those flexibility periods have been prolonged at least through mid-November.

Additionally, the new study confirms other studies that found telemedicine to increase treatment rates. The researchers discovered that people getting telehealth therapy for drug use disorders were almost 40 times more likely to be prescribed opioid use disorder prescriptions than those who did not.

A nationally representative sample of more than 47,000 individuals who took part in the 2021 National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services, served as the basis for the data used in the new study.

 

Opioid Company Looking To Avoid VA's $20M Settlement

A scheme to avoid paying more than $1 billion as part of a federal settlement for victims of the opioid crisis is being floated by one of the big pharmaceutical corporations that has been charged with flooding America with cheap, addictive pills.

One of the firms accused of disregarding rogue medication sales, sometimes known as pill mills, in order to maximize earnings is Mallinckrodt Pharmaceuticals, which generated more than a third of the opioids in use between 2006 and 2012.

In response to more than 3,000 lawsuits, the business declared bankruptcy in October 2020. It was able to negotiate a deal for $1.7 billion with every state in the union as a result of the action, which would have ended all ongoing claims, put a halt to additional litigation, and had it acknowledge no guilt.

According to rumors from last month, Mallinckrodt is looking for methods to avoid paying up. Of its $1.7 billion in debt, the business has already repaid $450 million. According to the Office of the Attorney General, the Dublin-based corporation owes the Commonwealth of Virginia a total of $21.1 million.

Securities and Exchange Commission filings provide some insight into the company's internal discussions, which seem to have been influenced by investor pressure. Essentially, these are two hedge firms trying to recover money they claim is due to them.

According to the document, the Board is actively assessing the Company's capital requirements in light of its commitments under the opioid settlement and its long-term debt.

If a second bankruptcy case is filed, the court may or may not accept it. But if approved, it would probably see money from the faltering corporation going to debtors first and opioid epidemic sufferers afterwards.

According to NPR, the total amount removed was close to $1 billion. The office is analyzing the Mallinckrodt reorganization plan that was accepted by the bankruptcy court and considering potential alternatives for the states, according to a representative for the AG office.

The corporation has to be held accountable, according to the CEO of the organization McShin, for healing. She claimed that it has been terrible for many years to meet families who have lost a loved one to opioids. A life cannot be valued, but you can make amends for your wrongs, the CEO stated. This money would aid in the community's and families' recovery from the anguish that these pharmaceuticals have brought about.

The Opioid Abatement Authority, a recently established state agency, is in charge of managing a large portion of the opioid settlement funds in Virginia. Localities in Virginia that apply and can prove to the OAA that they will utilize the cash for abatement will receive money from businesses.

Early initiatives have already received funding, including a women's shelter in Southwest Virginia's Washington County. The firm claims it would utilize the $116,000 that it received from the OAA to construct a 54-bed shelter in the heart of Abingdon.

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