FDA approves first generic naloxone nasal spray to treat opioid overdose

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.

“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

Read the full article here .. 

Medication Assisted Treatment ( MAT ) gets a big expansion in California

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Medication Assisted Treatment ( MAT ) gets a big expansion in California

In an effort to address the opioid epidemic throughout the state, the California Department of Health Care Services (DHCS) is implementing the California Medication Assisted Treatment (MAT) Expansion Project. The California MAT Expansion Project aims to increase access to MAT, reduce unmet treatment need, and reduce opioid overdose related deaths through the provision of prevention, treatment, and recovery activities.

Visit the SAMSHA / State of California website here: http://choosemat.org/

Drug Treatment Program for Couples

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Five States to Pilot ‘Rating System for Addiction Treatment Programs’

The rating system would drive improvement by setting a standard in the industry and increasing transparency and accountability.  Five states are partnering with national nonprofit Shatterproof to create the Rating System for Addiction Treatment Programs — a system that would essentially do for addiction treatment centers what TripAdvisor does for hotels.  The system, according to the organization, will deliver “trustworthy, standardized information about the levels and quality of care offered at all types of treatment centers.”

The first three states are Louisiana, Massachusetts and New York, and they’ll be joined by two more, which Shatterproof says it will announce in the next few weeks.

SETTING A STANDARD
Creating such a system “will drive improvement among treatment programs by increasing accountability and transparency, and it will supply states and health-care payers with the information necessary to reward high-quality care,” according to Shatterproof, which Founder and CEO Gary Mendell launched after his son committed suicide over the shame he felt about his own addiction.

Abuse of tobacco, alcohol, illicit drugs and prescription opioids costs more than $740 billion annually by way of crime, lost work productivity and health care, according to the National Institute on Drug Abuse. And according to a survey by the Substance Abuse and Mental Health Services Administration, as many as 90 percent of those who need drug rehab the most don’t receive it.

For those who do receive help, no system exists that makes it easy to choose a quality treatment program.

“The quality of care varies widely among addiction treatment programs, and individuals looking for care can’t identify high-quality programs,” Mendell said in a press release. “It is time a standard be set across all of addiction treatment, and the entire system aligns behind evidence-based care.”

Within the addiction treatment field, many addiction treatment practices are based not on what the evidence and research show best improves patient outcomes, said Samantha Arsenault, director of national treatment quality initiatives at Shatterproof, but on people’s life experiences, their philosophies about addiction or on payment structures versus what is best for the patient.

“One concrete example of that is that we are in the wake of an opioid epidemic and yet 60 percent of the specialty addiction treatment programs in the U.S. don’t offer a single medication to treat opioid use disorder,” she told Government Technology. “That would be like saying, ‘We are in the height of a diabetes crisis and 60 percent of the facilities that treat diabetes don’t offer insulin.’”

And this is why Shatterproof finds it absolutely critical not only to bring transparency for people seeking treatment so they can locate high-quality care, Arsenault added, but also to bring accountability to adhering to those best practices within the industry.

Read more here .. 

FDA to broaden access to medication-assisted treatment for opioid addiction

New federal drug rehab bill inspired by “Florida Shuffle”

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OxyContin maker Purdue Pharma explores bankruptcy

OxyContin maker Purdue Pharma LP is exploring filing for bankruptcy to address potentially significant liabilities from roughly 2,000 lawsuits alleging the drug manufacturer contributed to the deadly opioid crisis sweeping the United States, people familiar with the matter said on Monday.

The potential move shows how Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the drugmaker of misleading doctors and patients about risks associated with prolonged use of its prescription opioids.

Purdue denies the allegations, arguing that the U.S. Food and Drug Administration-approved labels for its opioids carried warnings about the risk of abuse and misuse associated with the pain treatments.

Filing for Chapter 11 protection would halt the lawsuits and allow Purdue to negotiate legal claims with plaintiffs under the supervision of a U.S. bankruptcy judge, the sources said.

Shares of Endo International PLC and Insys Therapeutics Inc, two companies that like Purdue have been named in lawsuits related to the U.S. opioid epidemic, were down more than 12 percent and more than 5 percent, respectively, on Monday morning.

More than 1,600 lawsuits accusing Purdue and other opioid manufacturers of using deceptive practices to push addictive drugs that led to fatal overdoses are consolidated in an Ohio federal court. Purdue has held discussions to resolve the litigation with plaintiffs’ lawyers, who have often compared the cases to widespread lawsuits against the tobacco industry that resulted in a $246 billion settlement in 1998.

BANKRUPTCY FILING NOT CERTAIN
A Purdue bankruptcy filing is not certain, the sources said. The Stamford, Connecticut-based company has not made any final decisions and could instead continue fighting the lawsuits, they said.

“As a privately-held company, it has been Purdue Pharma’s longstanding policy not to comment on our financial or legal strategy,” Purdue said in a statement.

“We are, however, committed to ensuring that our business remains strong and sustainable. We have ample liquidity and remain committed to meeting our obligations to the patients who benefit from our medicines, our suppliers and other business partners.”

Read the complete article at Reuters.com

Kentucky sues Walgreens for its alleged role in the opioid crisis

The more opioids doctors prescribe, the more money they make

 

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Doctors say controversial treatment for new moms with drug addiction a success

Doctors say a treatment strategy is a proven success in battling the opioid epidemic among new mothers even though it still has some opponents.

Doctors say a treatment strategy is a proven success in battling the opioid epidemic among new mothers even though it still has some opponents.

Since the beginning of the opioid epidemic, there has been a disconnect in treatment for pregnant women and continuing that treatment after they give birth.

Many times, pregnant women would be prescribed a form of medically assisted treatment (MAT), and then after the baby came, they’d go back to their old habits. But now, treatment specialists are making sure the new moms stay on track after they have given birth.

“It was almost like, ‘This is okay. I can be a mom again. I can have that title back. I have this other chance,'” Bethany Wilson explained.

Wilson went through the recently-opened University of Kentucky “Pathways Beyond Birth” program to continue to receive MAT. MAT, like Suboxone, has been a controversial treatment for opioid abuse because of diversion and its own abuse tendencies.

However, Wilson said MAT can also save lives.

“A lot of times we look at each other, and we’re like, ‘Well, you’re not sober because you’re on MAT.'”

She said the more people start talking about MAT as an option for treatment, the better off new mothers will be.

“It’s very hush, hush. So if you don’t hear those and you’re hearing negative things, it won’t move forward and get better.”

Wilson was close to death battling a heart problem caused by drug abuse.

“I had endocarditis. I was in septic shock, I had a stroke, I was suffering from liver and kidney failure — all these different things,” she recalled. “They called my family in to come and say their goodbyes. They didn’t expect me to make it through the first night.”

Wilson stayed in the hospital for months. When she was discharged, she was to serve one year in jail because of prior legal issues, but she only made it about a month before the infection put her back in the hospital. She ended up being incarcerated in the hospital.

“Even after all of that, I still struggled to be sober,” Wilson said, admitting to once again using drugs.

Since the beginning of the opioid epidemic, there has been a disconnect in treatment for pregnant women and continuing that treatment after they give birth.

Many times, pregnant women would be prescribed a form of medically assisted treatment (MAT), and then after the baby came, they’d go back to their old habits. But now, treatment specialists are making sure the new moms stay on track after they have given birth.

“It was almost like, ‘This is okay. I can be a mom again. I can have that title back. I have this other chance,'” Bethany Wilson explained.

Wilson went through the recently-opened University of Kentucky “Pathways Beyond Birth” program to continue to receive MAT. MAT, like Suboxone, has been a controversial treatment for opioid abuse because of diversion and its own abuse tendencies.

However, Wilson said MAT can also save lives.

“A lot of times we look at each other, and we’re like, ‘Well, you’re not sober because you’re on MAT.'”

She said the more people start talking about MAT as an option for treatment, the better off new mothers will be.

“It’s very hush, hush. So if you don’t hear those and you’re hearing negative things, it won’t move forward and get better.”

Wilson was close to death battling a heart problem caused by drug abuse.

“I had endocarditis. I was in septic shock, I had a stroke, I was suffering from liver and kidney failure — all these different things,” she recalled. “They called my family in to come and say their goodbyes. They didn’t expect me to make it through the first night.”

Wilson stayed in the hospital for months. When she was discharged, she was to serve one year in jail because of prior legal issues, but she only made it about a month before the infection put her back in the hospital. She ended up being incarcerated in the hospital.

“Even after all of that, I still struggled to be sober,” Wilson said, admitting to once again using drugs.

Anti-Craving Therapy

 

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Novel app may help anticipate opioid overdose

A recently developed app identified changes in breathing patterns that preceded likely opioid overdoses, as well as during an actual overdose, according to a report recently published in Science Translational Medicine.

“Existing, human-based approaches to diagnose overdose rely on medical-grade equipment or trained recognition of diagnostic signs of opioid toxicity system. … Validating the efficacy of any opioid toxicity system requires access to patients and data while high-risk opioid use occurs, which is difficult because this can represent a medically life-threatening situation, Rajalakshmi Nandakumar, a PhD candidate at the Paul G. Allen School of Computer Science and Engineering, University of Washington, and colleagues wrote.

Researchers created an algorithm that used sonar to monitor patients’ breathing rate and identify when an opioid overdose has occurred. The app accurately identified respiratory depression, apnea and gross motor movements tied to acute opioid toxicity.

The app, named Second Chance, was then tested in 209 patients that used the legally-sanctioned supervised injection facility in Vancouver, British Columbia.

“We asked participants to prepare their drugs like they normally would, but then we monitored them for a minute pre-injection so the algorithm could get a baseline value for their breathing rate,” Nandakumar said in a press release. “After we got a baseline, we continued monitoring during the injection and then for 5 minutes afterward, because that’s the window when overdose symptoms occur.”

Researchers found that Second Chance identified postinjection, opioid-induced central apnea with 96% sensitivity and 98% specificity. The app also identified respiratory depression with 87% sensitivity and 89% specificity.

Nandakumar and colleagues also tested Second Chance in 20 simulated overdose events in the operating room during routine induction of general anesthe

 

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The 5 Important Aspects of your Life and How Substance Abuse Affects Them

Every action a person performs in his life has an effect on him. Repetitive and constant actions have an even bigger and deeper impact on how his life is. Of course, the facets of his life cannot be contained into only four or five aspects. It is more complex and diverse in actuality. Generally speaking however and in common experiences for most substance abusers, the next 5 departments in one’s precious existence are immensely affected by drug and alcohol abuse, which imminently require affordable drug rehab. Watch out for the signs below because these could serve as red flags as to when to resort for affordable drug rehab.

Physical Capability and Beauty

The appearance of a person is influenced by what he takes in his body thus the saying what you eat is what you are. Healthy and nutritious food apparently makes a glowing and strong physique while alcohol and drugs does otherwise. Some common effects of consistent substance use on people are:

• Heart problems
• Respiratory problems, lung cancer, emphysema and difficulty breathing
• Abdominal pain, vomiting, constipation, diarrhea, nausea
• Kidney and liver damage
• Changes in appetite – sudden lose weight or gain weight
• Changes in body temperature
• Changes in sleeping patterns – insomnia or oversleeping
• Bloodshot eyes
• Halitosis and body odors
• Slurred speech
• Impaired coordination
• Dry skin and discoloration
• Poor grooming

Drug and alcohol use does not only affect one’s internal organs and mental ability but it does influence one’s looks and capacity to function.

Mental Health and Prowess

Probably the most affected faculty in one’s life in drug and alcohol use is one’s psychological well being. Especially that the different kinds of drugs and alcohol have different effects on the brain, the varied chemical reactions messes up with the brain’s function. Some are depressants while the others are stimulants. Excessive intake of the same kind or the large consistent dosage of various kinds induces extreme consequences as well. Besides low inhibition and impaired judgment, drugs and alcohol affects one’s mind in more ways such as:

• Mood Swings
• Anxiety
• Depression
• Confusion
• Paranoia
• Hallucinations
• Violence towards self and others
• Detachment and disinterest in daily things
• Symptoms of mental illness
• Tolerance and eventually dependence on the substance
• Reckless desires and behavior

Social Adaptability and Love

When one is physically incapable to fully function due to drugs, has poor grooming, and has poor judgment, his social adaptability becomes impaired as well. His relationships with everyone including his elderly, siblings, children, relatives, friends, and romantic partner become damaged. He is most likely to misunderstand friends and family’s intention to bring him to drug detox centers. He is most likely to verbally and physically harass others. He is most likely to steal things and money from others. He is most likely to get involved in more intricate and bigger illegal activities because of his substance addiction. Because of this, his interaction with the society becomes changed and altered. His freedom is lessen, and his life becomes a risky routine. In order to relieve this stressful situation, one must seek help from drug detox centers.

Career and Dreams

Alcohol and drug abuse occurs to all age groups including those that are still under formal education, those that are working, and those that have already retired. Either one is a student, an employee, business person, or retired, he has these aspirations and goals he has to fulfill in life. Drugs and alcohol however gets in the way. Students drop out because of uncontrolled substance usage – they would wallow in debts or get into drug related conflicts. Career people loses balance over when to work and when not to work, when to stand up against the boss and coworkers, and when not to. Businessmen may lose control over expenditures directed by their unsatisfied substance craving. Retired individuals may get distracted of their aim once they get the free time they longed for. Drug and alcohol are destroyers of career and aspirations.

Life and Spirituality

One does not necessarily have to be religious to be spiritual. Life itself is a spiritual journey – a series of motivations towards goals and falling out of track. The effects of drugs and alcohol on a person are not limited to physical, mental, social, and career because these things occupy a large portion of one’s life. When these parts are damaged, the whole life is imbalanced as well. So get a grip of everything. Like how addiction slowly crept into your system, remove it step by step as well.

Through the best drug rehab you can bit by bit reverse the effects that substance abuse has brought to your life. You can regain control over your life again through the power of the strong motivation that’s already in you and the science of detoxification. The best drug rehab will kick drug and alcohol out of your life and reinstate you as the master of yourself.

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