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☆ U.S. FDA approves second over-the-counter opioid overdose reversal drug
▼ + stars: | 2023-07-28 | by ( ) www.cnbc.com time to read: +1 min

Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc to manufacture RiVive.

Persons: drugmaker, Michael Hufford, BioSolutions Organizations: Reduction Coalition, U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc Locations: Baltimore, U.S, United States

☆ US FDA approves second over-the-counter opioid overdose reversal drug
▼ + stars: | 2023-07-28 | by ( ) www.reuters.com time to read: +1 min

July 28 (Reuters) - The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc (CTLT.N) to manufacture RiVive. Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: drugmaker, Michael Hufford, Sriparna Roy, Bhanvi, Pooja Desai Organizations: U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc, Thomson Locations: U.S, United States, Bengaluru

☆ In Phoenix, Firefighters Battle an Invisible Inferno
▼ + stars: | 2023-07-16 | by ( Jack Healy | More About Jack Healy | ) www.nytimes.com time to read: +1 min

On the hottest days, an additional engine is often dispatched to fight fires as a safeguard against the draining heat’s effects on fire crews. After a relatively mild and wet winter and spring, heat calls to the Phoenix Fire Department are higher this summer compared with last year, a department spokeswoman said. The department said it did not yet have precise figures, but a digital readout of all the active fire calls around Phoenix offered a glimpse. At 3 p.m. on Saturday, about one of every 10 calls was from someone overwhelmed by the day’s heat. There was a dehydrated 69-year-old hiker who had to be wheeled off a trail near the cowboy-inflected town of Cave Creek.

Persons: Captain DiCosmo, Deirdre Organizations: Phoenix Fire Department, Phoenix, telltale Locations: Cave

☆ Opioids may not work for back pain, study finds
▼ + stars: | 2023-06-28 | by ( Kristen Rogers | ) edition.cnn.com time to read: +7 min

The authors found that in terms of effects on back and neck pain, opioids weren’t any more helpful than the placebo. More people in the opioid group had ongoing pain at weeks 26 and 52 than in the placebo group. The opioid group had worse mental health scores and more reports of nausea, dizziness and constipation than the placebo group. Opioids and painThe study authors and experts who weren’t involved in the new study have theories on why opioids weren’t found to be more helpful than the placebo. “The good news is most people with acute low back pain and neck pain recover within 6 weeks naturally.”The authors studied nonspecific back or neck pain, which is pain with an unknown cause.

Persons: haven’t, ”, Christine Lin, Lin, Naloxone, ” Lin, weren’t, Mark D, Sullivan, Jane C, Ballantyne, ” Sullivan, ” Dr, John Finkenberg, wasn’t, don’t, Finkenberg, ” Finkenberg Organizations: CNN, American Spine Society, University of Sydney, University of Washington Locations: Australia, Sydney, San Diego

State and local officials have touted the settlements as providing desperately needed relief to communities hit hard by the crisis. But when the money will be paid out, and who will get it, remains far from clear, Reuters has found. Among the states where money is already reaching organizations on the ground are Massachusetts, Kentucky and Arizona. Most states share a significant portion of their total settlement funds with their city and county governments, which make their own independent decisions about how to spend. But in May, the board overseeing the state’s opioid settlement denied a joint application by Challenges and a county health department to fund harm reduction efforts, without explaining its decision.

Persons: Johnson, ”, Brandon Marshall, Julie Burns, Chris Bryan, Glenn Hegar, Lisa Ruzicka, “, Ruzicka, “ I’ve, drugmakers Johnson, Lauren Kestner, Tricia Christensen, –, we’re, ” Marc Burrows, Brendan Pierson, Disha, Alexia Garamfalvi, Claudia Parsons Organizations: Johnson, U.S . Centers for Disease Control, Reuters, District of Columbia, Reuters Graphics Reuters Graphics Reuters, Brown University School of Public Health, Rhode, Texas, Hope Foundation, Walgreens, Alliance, state’s Department of Health, Human Services, Prevention Services, Community Education Group, Alabama Attorney, University of Mississippi Medical, Inc, Thomson, & $ Locations: Massachusetts, Texas, United States, Maryland, Illinois, . Arkansas, Kentucky, Arizona, Rhode, RIZE Massachusetts, RIZE, Kansas, North Carolina, Charlotte, Appalachia, Mississippi, Alabama, New York

[1/3] Paramedics display a dose of the opioid overdose reversal drug Narcan, or Naloxone Hydrochloride, in an ambulance in Peabody, Massachusetts, U.S., August 8, 2017. The figure is up 0.7% from 108,825 overdoses recorded in the 12-month period ending January 2022, according to U.S. data. The U.S. drug overdose death toll crossed the 100,000-mark for the first time in 2021, as the COVID pandemic disrupted medical care and increased mental health problems. U.S. drug overdose deaths rose 13.7% between January 2021 and January 2022 and by 31.4% in the prior 12 months at the height of the pandemic. But the surge in overdose deaths began before the pandemic took hold due to abuse of prescription opioid painkillers and illegal drugs like heroin.

Persons: Brian Snyder, Joe Biden's, Biden, Tom Britton, Stacey McKenna, McKenna, Nandhini Srinivasan, Khushi, Bill Berkrot Organizations: REUTERS, U.S . Centers for Disease Control, Prevention, American Addiction Centers, U.S, R Street Institute, D.C, CDC, Thomson Locations: Peabody , Massachusetts, U.S, China, Mexico, Washington, Bengaluru

☆ Opinion | The Drug That Saves Lives Even if It’s Never Used
▼ + stars: | 2023-05-07 | by ( Elizabeth Spiers | ) www.nytimes.com time to read: +2 min

Although the drug has no major adverse effects, until later this year, New York State requires people to get some training before they can administer it. Dr. Avery, the vice chair for addiction psychiatry at Weill Cornell Medicine, had conducted many such trainings, and in his office that day he got right to it. Still, the drug has yet to become a standard part of the public’s tool kit. Dr. Avery, whose research is in negative attitudes toward addiction, says it’s because legal and regulatory issues were only part of the problem. It shapes the language we use to talk about addiction and the responses we think are appropriate.

☆ A former fentanyl user describes the first time she took the illicit drug laced with xylazine as 'the scariest experience of my life'
▼ + stars: | 2023-04-21 | by ( Kelly Burch | ) www.businessinsider.com time to read: +9 min

Opioids contributed to 80,411 overdose deaths in 2021, up from 68,630 deaths in 2020, data from the National Institute on Drug Abuse shows. Xylazine is a sedative that can lead to respiratory and cardiac issuesOpioids, like fentanyl, contributed to more than 80,000 overdose deaths in 2021. Mixing xylazine with fentanyl is particularly problematicMixing xylazine and fentanyl can amplify xylazine's sedative effect and the associated health risks. ReutersThe opioid overdose reversal drug Narcan, also known as naloxone, will not reverse the impact of xylazine, since the drug is not an opioid, according to the DEA. That's because opioids account for nearly 75% of all drug overdose deaths in the US.

☆ FDA Approves Narcan for Non-Prescription Sale
▼ + stars: | 2023-03-29 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

Narcan is an over-the-counter version of a widely used opioid-reversal nasal spray. People will soon be able to walk into a pharmacy and purchase medication to reverse an opioid overdose alongside other non-prescription items like aspirin and vitamins. The Food and Drug Administration on Wednesday said the overdose reversal medication Narcan could be sold over-the-counter for the first time since the opioid crisis began. Narcan’s manufacturer, Emergent Biosolutions Inc., said the nasal-spray version of the medication naloxone would likely begin appearing on shelves by late summer. Emergent is the first company to gain approval to sell naloxone without a prescription.

☆ FDA Makes Overdose-Reversal Drug Narcan Available Over-the-Counter
▼ + stars: | 2023-03-29 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

The nasal-spray version of naloxone will likely be available on pharmacy shelves by late summer. People will soon be able to walk into a pharmacy and purchase medication to reverse an opioid overdose alongside other nonprescription items like aspirin and vitamins. The Food and Drug Administration on Wednesday said the overdose reversal medication Narcan could be sold over-the-counter for the first time since the opioid crisis began. Narcan’s manufacturer, Emergent BioSolutions Inc., said the nasal-spray version of the medication naloxone would likely begin appearing on shelves by late summer. Emergent is the first company to gain approval to sell naloxone without a prescription.

☆ US FDA approves first OTC opioid overdose reversal drug
▼ + stars: | 2023-03-29 | by ( ) www.reuters.com time to read: +2 min

[1/2] A box of NARCAN nasal spray is photographed at an outpatient treatment center in Indiana, Pennsylvania, U.S. on August 9, 2017. The approval for OTC use of the naloxone-based nasal spray will help align the federal government's stance with states that have provisions to offer the drug without prescription at pharmacies. Drug-related overdose deaths in the United States rose about 15% year-over-year to more than 100,000 in 2021, as per official data. While the approval puts Emergent ahead in the OTC product race, analysts have said it is not likely to derive significant sales from the approval. Benchmark analyst Robert Wasserman said ahead of the approval that Narcan sales peaked in 2020 and have declined since.

☆ FDA approves over-the-counter sales of lifesaving opioid overdose treatment Narcan nasal spray
▼ + stars: | 2023-03-29 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration on Wednesday approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses, a decision that promises to significantly expand access to the lifesaving treatment. The FDA's decision means people will be able to buy the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. FDA Commissioner Dr. Robert Califf, in a statement, said the agency is encouraging the company to make the nasal spray available as soon as possible at an affordable price. The nasal spray must be administered as soon as an overdose is suspected. Two nasal spray devices typically come in a single package.

☆ The government is cracking down on online prescriptions. Patients with addiction and the startups caring for them are caught up in the fight.
▼ + stars: | 2023-03-27 | by ( Blake Dodge | ) www.businessinsider.com time to read: +9 min

Proposed rules would limit online addiction treatmentIn February, the Drug Enforcement Administration, or DEA, published much-anticipated rules meant to set the record straight on online prescribing. The rules, if implemented, generally don't allow providers to prescribe controlled medications online if they don't see the patients in person. For buprenorphine and other drugs, there's an exception that would allow for initial 30-day prescriptions for online patients. Some patients are flights away from in-person careFor some patients, especially in rural areas, in-person appointments are hard to find. Last year, Alabama passed a new law prohibiting providers from prescribing controlled drugs to patients they hadn't seen in person within the past year.

Feb 15 (Reuters) - Emergent BioSolutions Inc's (EBS.N) over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market. The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide. Naloxone rapidly reverses or blocks the effects of an overdose, restoring normal respiration. However, most panelists emphasized that OTC use of the nasal spray was safe and proposed ways to improve its labeling, to avoid using the drug wrong. Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.

☆ FDA advisors recommend over-the-counter use of life-saving opioid overdose treatment Narcan
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Narcan nasal spray quickly reverses an overdose from heroin and prescription painkillers. The Food and Drug Administration's independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment. Emergent BioSolutions ' Narcan is the most commonly sold treatment for opioid overdoses. Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.

☆ 2 Colorado libraries close after meth contamination
▼ + stars: | 2023-01-16 | by ( The Associated Press | ) www.nbcnews.com time to read: +5 min

ENGLEWOOD, Colo. — For the second time in a month, a Colorado library has closed its doors to clean up methamphetamine contamination. The city of about 33,000 just south of Denver decided to test for the drug after officials in the nearby college town of Boulder closed its main library after finding meth contamination, Harguth said. The group declined to comment on whether drug use has been increasing in libraries, citing a lack of up-to-date data. They also pointed out that standards for how much meth contamination is acceptable were developed with an eye toward homes, where frequent exposure is more likely than in public buildings. The Englewood library has made some changes to help homeless people who go there.

☆ Teva says opioids settlement to move forward in U.S
▼ + stars: | 2023-01-09 | by ( Reuters Staff | ) www.reuters.com time to read: +1 min

The logo of Teva Pharmaceutical Industries is seen in Tel Aviv, Israel February 19, 2019. REUTERS/Amir Cohen(Reuters) -Israeli drugmaker Teva Pharmaceutical Industries Ltd said there was sufficient participation from U.S. states and local authorities to move forward with its nationwide settlement agreement to resolve opioid-related claims and litigation. Teva said on Monday it has either already settled with or confirmed participation from 48 of the 50 states and will continue to pursue participation by the states that are yet to join. The litigation over opioids, which began in 2017, has yielded more than $40 billion in settlements from drugmakers, distributors and pharmacy chains. More than 932,000 people have died since 1999 from a drug overdose, according to Federal data.

The problem was the Neris had switched to a new, high-deductible health insurance plan to save money. The 2010 Affordable Care Act expanded access to health insurance, so companies were faced with covering more people than ever before. But the epinephrine auto-injectors — which deliver a shot of epinephrine and are the only emergency medicine available for life-threatening allergic reactions — usually are not. But AHIP (formerly known as America’s Health Insurance Plans), a group that represents such companies, said drug manufacturers are to blame. Fight it with your health care provider, fight it with your insurance company.”“No almost never means no in health insurance,” he said.

☆ FDA Fast-Tracks Review of Overdose Drug Naloxone for Use Without Prescription
▼ + stars: | 2022-12-26 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

A worker with the Brooklyn Community Recovery Center demonstrates how to use an overdose-reversal drug. A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

☆ FDA Fast-Tracks Overdose Drug Naloxone for Use Without Prescription
▼ + stars: | 2022-12-26 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

☆ Drug overdose deaths among teenagers surged during the pandemic driven by illicit fentanyl
▼ + stars: | 2022-12-19 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Drug overdose deaths among adolescents surged during the Covid-19 pandemic, driven overwhelmingly by illicit fentanyl, according to a report from the Centers for Disease Control and Prevention. Monthly drug overdose deaths nearly tripled among adolescents ages 10 to 19 during the first two years of the pandemic. But illegally manufactured fentanyl, often consumed as a pill, has become an increasingly common cause of overdose deaths. There was evidence that 25% of adolescent overdose deaths may have involved counterfeit pills that often resemble OxyContin or Xanax but frequently include fentanyl as well. Teens should also be educated about the potential presence of illicit fentanyl in pills that may resemble prescription drugs.

☆ Fentanyl Awareness Campaign Urges Parents to ‘Drop the F-Bomb’ With Their Kids
▼ + stars: | 2022-12-13 | by ( Megan Graham | ) www.wsj.com time to read: +2 min

A new campaign from the Ad Council and Meta Platforms Inc. is encouraging parents of teen and young-adult children to speak to them about the dangers of fentanyl. The campaign aimed at parents follows a previous effort speaking to kids directly about fentanyl. The campaign, which is set to roll out Wednesday, includes videos of parents having conversations with children about the risks of fentanyl. The Ad Council also aims to expand the campaign beyond Meta platforms, including with digital display ads on other websites. Next, the Ad Council plans to educate 18-to-24-year-olds about the benefits of carrying naloxone.

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.

☆ Here's what health insurance providers are doing to lower the cost of prescription drugs
▼ + stars: | 2022-12-09 | by ( Sponsor Post | Created Insider Studios With Unitedhealthcare | ) www.businessinsider.com time to read: +6 min

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.

☆ More than 180,000 people overdosed on opioids and survived in the past year, new White House dashboard shows
▼ + stars: | 2022-12-08 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +5 min

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.

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