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Just because rural areas are less populated doesn’t mean it’s cheaper to provide health services there. She recommends that rural counties explore lower-cost, evidence-based options like distributing naloxone, funding syringe service programs, or connecting people to housing or employment. “We couldn’t function if we didn’t partner for lots of different services.”In Colorado, pooling funds is built into the state’s model for managing opioid settlement money. “Nobody has paid any attention to our rural areas and this problem for years,” Laske said. They cross-referenced the results with a list of allowable uses for the $9 million in settlement funds they’ll receive over 18 years to create a priority grid.
Americans pay up to three times more for prescription drugs than people in other countries. In the US, people pay up to three times more for prescription drugs than people in other countries, and one in four Americans who take prescription drugs have trouble affording their medications. Because of the high cost of the drug, many diabetes patients cannot afford to pay for the treatment they need. Fast Facts: In the US, people pay 3X more for prescription drugs than people in other countries. The company is eliminating out-of-pocket costs for insulin and four other commonly used prescription drugs: epinephrine, glucagon, naloxone, and albuterol.
This first-of-its-kind dashboard was developed to track nonfatal opioid overdoses, which have become a growing public health concern as the US struggles with a decades-long opioid epidemic. It will “empower local communities” to tailor their opioid overdose responses and track their progress, Gupta said. “We know that there are significantly more nonfatal overdoses than fatal ones, of which there are over 100,000 a year. Across the United States, the powerful synthetic opioid fentanyl has become the most commonly used drug involved in drug overdoses. In 2020, a report from the CDC found that opioids have “substantial involvement” in nonfatal overdoses, including those involving other types of drugs, and these types of nonfatal overdoses are on the rise.
U.S. FDA grants priority review for Emergent's OTC opioid drug
  + stars: | 2022-12-06 | by ( ) www.reuters.com   time to read: +1 min
Companies Emergent BioSolutions Inc FollowDec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) on Tuesday said its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. If approved following the agency's priority review by March 29, the spray could become the first naloxone-based drug to be sold over the counter. The worsening opioid crisis has prompted U.S. President Joe Biden's administration to develop newer strategies, including the use of naloxone. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.
Dec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said. If approved, Narcan could face competition from generic versions of the drug, pressuring margins for Emergent, Cowen analyst Boris Peaker said. Rival Opiant Pharmaceuticals' (OPNT.O) drug nalmafene is also under the FDA's review and could pose additional risk to Narcan sales, as it provides better protection against an opioid overdose, Peaker added.
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of naloxone to combat the overdose crisis from bootleg fentanyl. A startup vying to produce one of the first over-the-counter overdose-reversal medications said it had submitted results to the Food and Drug Administration showing that its drug works more quickly than prescription-only versions. The randomized trial of 60 healthy volunteers evaluated naloxone absorption from Pocket Naloxone Corp.’s nasal swab versus a 4 milligram nasal-spray delivery and found 74% higher exposure 2.5 minutes after dosing and 19% higher exposure at 5 minutes. Naloxone works by blocking the effects of opioids.
Nov 22 (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.TA) and AbbVie Inc (ABBV.N) have finalized the terms of settlements worth more than $6.6 billion to resolve thousands of lawsuits by U.S. state and local governments over the marketing of opioid painkillers, the companies and lawyers for the governments said Tuesday. Under the deals, first announced in July, Israel-based Teva will pay up to $4.25 billion, including a supply of the overdose drug naloxone. AbbVie will pay up to $2.37 billion. The final amounts of the settlements will depend on how many state and local governments opt into them. The sprawling litigation over opioids, which began in 2017, has yielded more than $40 billion in settlements with drugmakers, distributors and pharmacy chains.
The following are major companies that were accused of contributing to the crisis, and settlements or judgments involving those companies. Teva Pharmaceutical Industries Ltd (TEVA.TA)-In November, finalized claims nationwide for $4.25 billion, some of which is to be paid as a supply of the overdose-reversing drug naloxone. AbbVie Inc (ABBV.N)-In November, finalized a $2.37 billion nationwide settlement resolving claims against Allergan, a company it acquired in 2020. Endo International Plc (ENDPQ.PK)-Reached a $450 million settlement with more than 30 states as part of a bankruptcy filing in August. Mallinckrodt Plc (MNK.A)-Reached a $1.7 billion nationwide settlement as part of its bankruptcy reorganization plan, approved in February.
The Food and Drug Administration is pushing for drugmakers to apply for over-the-counter approval for naloxone, the opioid overdose antidote. Naloxone is only offered as a prescription, though many states have found work-arounds to make the drug easier to get. By making the medication available over the counter, it removes stigma, said Dr. Scott Hadland, an addiction specialist at Mass General for Children in Boston. Nearly 20,000 deaths from overdose, between 1999 and 2020, have been prevented by the self-administering of naloxone, according to the FDA. The FDA noted that over-the-counter naloxone will not divert supplies away from community-based naloxone distribution programs and hospitals.
Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The Food and Drug Administration on Tuesday indicated it might approve over-the-counter nasal sprays and autoinjectors that prevent opioid overdoses, part of its efforts to expand access to a life-saving drug called naloxone. The FDA, in a preliminary assessment, said nasal spray containing up to 4mg of naloxone and autoinjectors that administer up to a 2 mg dose of the drug might be safe and effective for people to self administer without a prescription. Opioid overdose deaths surged 65% during the Covid-19 pandemic from 47,000 in 2019 to nearly 78,000 in 2021, according to data from the Centers for Disease Control and Prevention. More than 564,000 people have died from opioids in the U.S. since 1999 in three waves — first from prescription opioids, then from heroin and most recently from fentanyl.
Opioid overdose reversal drug likely safe for OTC use, says FDA
  + stars: | 2022-11-15 | by ( ) www.reuters.com   time to read: +1 min
Nov 15 (Reuters) - Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration (FDA) said on Tuesday, potentially paving the way for its use federally. The FDA would still require data on individual products from manufacturers for them to be available over the counter at a federal level. The drug regulator's preliminary assessment included up to 4 milligrams dose of naloxone nasal spray and up to 2 milligrams when given through an auto injector. The agency said the assessment does not cover higher dose naloxone products and those supplied in other forms for which more data was needed. More than 16,000 people have died from overdoses involving prescription opioids in 2020, according to government data.
A powerful animal tranquilizer is increasingly showing up in the illicit drug supply, putting unsuspecting users at risk for hard to treat overdoses and dangerous side effects, the Food and Drug Administration warned Tuesday. The drug, called xylazine, is primarily found in heroin and illicit fentanyl, the FDA said, and overdoses can look similar to an opioid overdose. But because xylazine isn't an opioid, these overdoses can't be reversed using the antidote naloxone, or Narcan. It's also linked with gaping skin wounds not seen with other injectable drug use, the FDA said. Because the drug isn't included in routine toxicology screenings, the FDA added, it may be underdetected in overdoses.
"Colored fentanyl pills have been around for a few years. At the time, the agency said that it and its law enforcement partners seized the brightly colored fentanyl and fentanyl pills across 18 states. While he and his colleagues are aware of rainbow fentanyl warnings, he hasn't heard any patients or parents mention it. When it comes to rainbow fentanyl, "the fentanyl itself is going to be the same issue as the counterfeit pharmaceutical fentanyl. The only difference between rainbow fentanyl and the fentanyl products of the past appears to be the coloring.
US President Joe Biden speaks about the DISCLOSE Act at the Roosevelt Room of the White House in Washington, DC on September 20, 2022. The Biden administration announced Friday it is awarding $1.5 billion in grants to help states, territories and tribal lands combat the opioid crisis. More than $104 million in funding will specifically aim to support rural communities, which have been particularly hard-hit by the opioid crisis. Biden also called for an investment of more than $42.5 billion in funding for National Drug Control Agencies as part of his 2023 fiscal-year budget. The investment would mark a $3.2 billion increase from the previous year.
A Cataldo Ambulance medic holds used doses of naloxone after medics revived a man in his 40's who was found unresponsive from an opioid overdose in the Boston suburb of Salem, Massachusetts, U.S., August 9, 2017. REUTERS/Brian SnyderWASHINGTON, Sept 23 (Reuters) - U.S. President Joe Biden will announce on Friday nearly $1.5 billion to fund access to medications for opioid overdoses, sanctions against traffickers, and increased funding for law enforcement, the White House said. The Biden administration is keen to show it is taking action on a worsening nationwide opioid crisis, which according to U.S. Centers for Disease Control and Prevention data fueled more than 107,000 drug overdose deaths in 2021, a nearly 15% increase from the previous year. Biden will announce nearly $1.5 billion in grants from the U.S. Department of Health and Human Services to states, tribal lands and territories, said Miriam Delphin-Rittmon, assistant secretary for mental health and substance use. The funds will go toward treating substance-use disorders and removing barriers to key tools like naloxone, a medication that can reverse opioid overdoses, Delphin-Rittmon said.
Morrisey recently announced a settlement with Rite Aid for up to $30 million to resolve similar litigation. Morrisey said the deal with CVS includes a provision that means West Virginia can still receive money from any future national settlements that arise. The money from all opioid settlements will be distributed throughout the state to abate the opioid crisis. In August, West Virginia cities and counties reached a $400 million tentative settlement with three major U.S. drug distributors: AmerisourceBergen, Cardinal Health and McKesson. In April, Morrisey announced the state would receive $99 million in a settlement finalized with Johnson & Johnson’s subsidiary Janssen Pharmaceuticals Inc.
CNN —Drug overdose deaths in the United States increased sharply throughout the Covid-19 pandemic, reaching record levels in 2021. But by 2021, rates among Black men had surpassed those of American Indian men. In 2021, overdose death rates among Black men ages 35 to 64 were higher than any other demographic group. Drug overdose deaths continue to rise, with the CDC’s latest provisional data showing that more than 109,000 people died of a drug overdose in the 12-month period ending March 2022. Relative to state population, rates of overdose deaths were by far the highest in West Virginia, with 83 overdose deaths for every 100,000 residents.
Two dangerous and highly potent illicit drugs are increasingly infiltrating the supply of street drugs, putting people at risk for deadly overdoses. "Nitazenes are an emerging group of highly potent psychoactive substances" that are often left out of drug screening tests, the report's authors wrote. The highly potent opioids has been found in street drugs across the Midwest and Northeast since 2019, but has since spread to other states. She and her colleagues have recently begun to detect nitazenes in illicit drug samples gathered across the state. The drug has also been linked to reports of skin abscesses, not unlike cases seen in other injectable drug users.
Opioid Crisis Fast Facts
  + stars: | 2017-09-18 | by ( Cnn Editorial Research | ) edition.cnn.com   time to read: +15 min
March 29, 2017 - Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. April 9, 2018 - The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. The settlement will be used to fund addiction research and help cities and counties with the opioid crisis. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. November 15, 2022 - Walmart agrees to the framework of a $3.1 billion settlement, which resolves allegations from multiple states’ attorneys general that the company failed to regulate opioid prescriptions contributing to the nationwide opioid crisis.
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