Some pharmacies thwart efforts to improve access to the opioid overdose reversal drug

In response to the opioid crisis, all 50 states have changed their laws to make naloxone, the overdose reversal drug, easier to get and use.

Many states have issued standing medication orders so pharmacists can dispense the life-saving antidote without a prescription. Cities such as Philadelphia have campaigns encouraging family and friends of people at risk of overdose to carry naloxone.

Whether this is saving lives is just beginning to be evaluated, but one obstacle is clear: Many pharmacies haven’t gotten with the program.

In California, 3 out of 4 pharmacies still required a doctor’s prescription for naloxone early this year—two years after the law was changed, according to a new study by the University of California, San Francisco. Only half the stores had the easy-to-administer nasal spray in stock.

In Texas, where big chains such as CVS and Walgreens were surveyed, more than 80 percent dispensed naloxone without a prescription—but a quarter didn’t have it in stock, a study by the University of Texas found.

Why are pharmacies a weak link in this public-health effort? “Lack of knowledge of legislation, lack of required training, stigma about substance use disorder, and time,” the California researchers wrote this week in the Journal of the American Medical Association, where both studies appear.

Recognizing ongoing access issues, a Philadelphia City Council committee on Tuesday recommended a bill that would require pharmacies to have a least one naloxone pack (with two doses) in stock. Council is expected to vote on the measure next week.

“We did a survey and found 25 percent of pharmacies don’t have it,” city Health Commissioner Thomas Farley said. “We want 100 percent to have it on hand.”

Almost 50,000 people died of opioid overdoses last year, according to federal data. In Pennsylvania, the death toll was more than 5,400, including 1,200 in Philadelphia. The epidemic has turned drug overdose into the leading cause of death among Americans under 50.

Naloxone, used by medical professionals and emergency responders for more than 40 years, reverses the potentially lethal effects of opioids, which depress breathing and induce sleepiness.

Though the most popular brand, Narcan, is not cheap—about $150 for a two-dose pack of the nasal spray—public and private insurance covers the drug, and community groups supply it for free as part of prevention programs. Philadelphia has distributed 57,000 doses through such programs since June 2017, Farley said.

On Tuesday, New Jersey launched an “opioid data dashboard” to track drug-related overdose indicators. It shows that 19,809 people in the state were given naloxone by emergency responders or police between June 2017 and September 2018. That includes 600 who died.

Eventually, the dashboard may include naloxone dispensed without prescription under the state’s standing order, said New Jersey Health Commissioner Shereef Elnahal.

The finding that most California pharmacies are ignoring that state’s naloxone access law “speaks to the stigma that still exists around opioid addiction,” Elnahal said. “We want to change that with strong public messaging.”

After Pennsylvania’s standing order took effect three years ago, community health nurses raised awareness by going to pharmacies in each county.

The impact of the order “is anecdotal at this point,” said Ray Barishansky, a deputy secretary with the state Department of Health. “But we are seeing an increase in the amount of naloxone being distributed.”

Studies are beginning to measure the effect of access laws, as well as so-called Good Samaritan laws that legally protect lay people who administer naloxone in an emergency.

In states with access laws, pharmacies dispensed 79 percent more naloxone between 2007 and 2016 than those in states without such laws, one study found. Another study linked access and Good Samaritan laws to a 14 percent reduction in opioid overdose deaths.

“It’s not a magic bullet,” said Corey S. Davis, deputy director of the Network for Public Health Law and a co-author of those two impact studies. “It’s not going to single-handedly solve the overdose crisis. But all the data we have suggest the more naloxone dispensing we have, the fewer deaths there will be.”

Davis hopes the next wave of naloxone access laws will require doctors to provide a prescription for the antidote to any patient taking opioids chronically.

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Many drugstores won’t dispense opioid antidote as required

(HealthDay)—People who overdose on opioids have one lifeline, the drug naloxone, but two new studies find that many pharmacies won’t offer this lifesaving antidote without a doctor’s blessing.

Though many states have passed laws mandating that naloxone be made available without a prescription, researchers from California found that fewer than 25 percent of pharmacies in that state would give the drug without a prescription. And in the second study from Texas, investigators found that although 8 in 10 drugstores would dispense the drug, less than 7 in 10 had naloxone in stock.

Why? A lack of training, a lack of desire to make room for the drug on their shelves, and outright moral objections to giving an opioid user a medication that might encourage drug abuse, the scientists said.

“We have an opioid crisis in our country, and we have a large number of opioid overdose deaths, about half of which are due to prescription opioids,” said Talia Puzantian, lead researcher of the first study, and associate professor of clinical sciences at Keck Graduate Institute School of Pharmacy and Health Sciences in Claremont, Calif.

People getting prescriptions for these narcotic painkillers may not think they are at risk for overdosing, she said. “But these drugs have significant safety issues,” Puzantian said.

Part of a pharmacist’s role is to educate patients about the dangers of opioids and make naloxone available when they think the patients may be at risk for an overdose, she said. These include people who are taking high doses of the painkillers or are mixing them with other drugs that can increase the risk.

Since 2016, California law has allowed pharmacists to provide naloxone without a prescription.

For the California study, Puzantian and her colleagues called more than 1,100 pharmacies asking if they would provide naloxone without a physician’s prescription. Fewer than 25 percent said they would. Of those, only about 50 percent stocked nasal spray naloxone, the researchers found.

Puzantian said that pharmacists need to be taught about the law allowing them to give patients naloxone without a prescription.

In addition, they need to have the drug on hand. Many pharmacies that don’t stock naloxone said they didn’t have the shelf space, given all the other more popular drugs they need to carry and the low demand for naloxone.

Some pharmacists have a moral objection to providing drugs to opioid users, Puzantian said. They believe that it only encourages drug abuse, but that’s not the case, she said.

“Opioid overdoses don’t only occur in people using heroin, so patients should talk with their pharmacists about whether they are at risk for overdose and whether they might be a good candidate for having naloxone on hand,” Puzantian said.

In the second study, researchers led by Kirk Evoy, a clinical assistant professor at the University of Texas at Austin, studied the availability of naloxone at chain pharmacies in the state. Texas also allows pharmacists to provide the drug without a prescription.

Of the 2,300 drugstores contacted, 84 percent said they would provide the drug, but only 69 percent had it on their shelves. The nasal spray form of the drug was the one most commonly available, the researchers found.

In drugstores that had the drug in stock and would provide it without a prescription, patients could walk into the pharmacy without having seen a doctor and obtain naloxone the same day in approximately 70 percent of the chain pharmacies contacted, Evoy said.

Although chain stores like CVS and Walmart stock naloxone, more need to make the drug available, he said.

“Hopefully, this study serves as a call to action for community pharmacies to better educate their pharmacists and support staff regarding naloxone access laws and company policies regarding naloxone dispensing,” Evoy said.

Dr. Sandeep Kapoor, director of screening, brief intervention and referral to treatment at Northwell Health in New Hyde Park, N.Y., said the public also needs to be educated about naloxone.

“We need to encourage education for the community, schools and hospitals to relieve apprehensions one may feel in going directly to a pharmacy to get naloxone,” said Kapoor, who was not involved with the studies.

It might be that people feel uncomfortable asking for naloxone because of fear or the stigma associated with opioid use, he said.

“We should continue identifying barriers to utilization and focus efforts to further normalize and destigmatize substance use disorder,” Kapoor said.

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Hypertension up to 40 increases the risk of heart disease

High blood pressure to 40 years can result in serious cardiovascular diseases. To such conclusion the American scientists.

A new study by American scientists has shown that young people, already suffering from high blood pressure before the age of 40 years are at high risk of cardiovascular diseases like heart failure, strokes, and blockage of blood vessels with aging. These findings are made on the basis of the analysis of health 4 851 young man aged 18 to 30 years, which for a certain period made measurements of blood pressure to 40 years. The study itself began in 1985. The participants were divided into four groups in accordance with the indicators of pressure – normal to the second stage of hypertension when the level of pressure steadily shown from 140/90 and above.

The study allowed to follow the health of these people for almost 20 years. The results showed that even slightly elevated blood pressure, as well as both stages of hypertension before 40 years significantly increased the risk of developing cardiovascular diseases later, compared to those young people who have the pressure to 40 years old should not be out of the norm. Note that in 2017, the standards of hypertension has decreased, and now the first stage of the disease is put under pressure from 130-139/80-89.

In accordance with the new regulations, tens of millions of people in Russia who consider themselves healthy may be faced with a diagnosis of first stage hypertension. So, they need to start treatment now and not wait for the indicators of pressure will be much higher. (READ MORE)

FDA Approves Sympazan

WARREN, N.J., Nov. 2, 2018 /PRNewswire/ — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Sympazan™ (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.1 Sympazan is the first and only oral film FDA-approved to treat seizures associated with LGS. Previously, clobazam was marketed as ONFI® and offered in two formulations – either tablet or oral suspension.2

"Aquestive Therapeutics is pleased to bring Sympazan to the LGS community," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "Treating LGS can be difficult; patients may have a hard time swallowing oral medications. We're optimistic Sympazan can help address unmet medical needs and be an important treatment option for this patient population."

LGS is a severe form of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disability.3 LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or cognitive impact.4,5 Challenges with treatment administration can lead to uncertain and inconsistent dosing, and increase the burden of care, particularly for patients that may be combative or resistant to treatment.5-8

Since FDA approval in 2011, clobazam tablets and oral suspension (brand name ONFI®) have been a trusted adjunctive treatment for LGS. In a Phase 3, randomized, double-blind, placebo-controlled study of 238 LGS patients, clobazam tablets significantly reduced the frequency of drop seizures (which involve falls) compared to baseline by 41 percent (low dose) to 68 percent (high dose) vs. 12 percent for placebo (p<0.05 for all doses vs. placebo).2,9 Please see more Important Safety Information below, including the Boxed Warning on the risks associated with concomitant use of opioids.

"Many LGS patients have a hard time swallowing pills and suspensions. This can make administering medication hard for caregivers," says Christina SanInocencio, Executive Director of the LGS Foundation. "We believe Sympazan will be welcomed by patients and caregivers impacted by LGS and searching for treatment solutions."

Sympazan is a formulation based on Aquestive's proven PharmFilm® technology. Multiple pharmacokinetic studies were conducted to compare Sympazan with ONFI. Based on the studies, Sympazan oral film was demonstrated to be bioequivalent to clobazam tablets and have comparable safety profiles.1 Aquestive's clinical development of Sympazan followed the 505(b)(2) regulatory pathway.

"Sympazan is the beginning of a meaningful CNS franchise for Aquestive," Kendall says. "We are actively working to advance more redesigned, proprietary treatments that can offer meaningful improvements for patients and caregivers who live with epilepsy and other complex conditions."

Aquestive plans to commercialize Sympazan in November, and has engaged Ashfield Healthcare, a company specializing in commercialization services, to build and train a highly qualified, national sales force. The sales force will focus on pediatric neurologists and epileptologists.

Sympazan oral film is berry flavored and offered in 5 mg, 10 mg, and 20 mg dosages to meet a range of LGS patient and caregiver needs.1

About Aquestive Therapeutics

Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

CONTRAINDICATIONS

Sympazan is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.

WARNINGS AND PRECAUTIONS

Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants
Sympazan has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.

Somnolence or Sedation
Sympazan causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of Sympazan is known.

Withdrawal Symptoms
Abrupt discontinuation of Sympazan should be avoided. The risk of withdrawal symptoms is greater with higher doses. Withdraw Sympazan gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.

Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue Sympazan at the first sign of rash, unless the rash is clearly not drug-related.

Physical and Psychological Dependence
Patients with a history of substance abuse should be under careful surveillance when receiving Sympazan.

Suicidal Behavior and Ideation
AEDs, including Sympazan, increase the risk of suicidal thoughts or behavior in patients. Patients treated with Sympazan should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients, their caregivers, and families of the increased risk of suicidal thoughts and behaviors. Advise them to be alert for and report immediately to healthcare providers any emergence or worsening signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.

ADVERSE REACTIONS

Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.

DRUG INTERACTIONS

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation. Concomitant use of Sympazan with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated. Hormonal contraceptives that are metabolized by CYP3A4; effectiveness may be diminished when given with Sympazan. Additional non-hormonal forms of contraception are recommended when using Sympazan. Dose adjustment may be necessary of drugs metabolized by CYP2D6 and of Sympazan when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: Sympazan may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. Sympazan is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Sympazan, discontinue nursing or discontinue the drug. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "project," "will," "would," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. Such statements include, but are not limited to, statements about regulatory approvals and pathways, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business strategies, market opportunities, financing, and other statements that are not historical facts.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials; the risks of delays in FDA approval of our drug candidates or failure to receive approval; the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); development of our sales and marketing capabilities; the rate and degree of market acceptance of our product candidates; the success of any competing products; the size and growth of our product markets; the effectiveness and safety of our product candidates; risks associated with intellectual property rights and infringement; unexpected patent developments; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Registration Statement on Form S-1 declared effective by the SEC on July 24, 2018. As with any pharmaceutical product candidate under development, there are significant risks with respect to the development, regulatory approval and commercialization of new products. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. We assume no obligation to update our forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required under applicable law.

References:

SOURCE Aquestive Therapeutics, Inc.

Posted: November 2018

Sympazan (clobazam) FDA Approval History

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To get cancer of the stomach through the kiss, perhaps because of H. pylori

Helicobacter or Helicobacter pylori bacterium can contribute to the infection of cancer through kissing, – this conclusion of the scientists was published by the Clutch. In particular, according to experts, Helicobacter causing stomach cancer.

Researchers their concern over the fact that the bacterium Helicobacter pylori (H. pylori) infected more than sixty percent of the world’s population. According to scientists, the H. pylori “refers to the carcinogens of the first class, and this means that the likelihood of cancer of the stomach because of the bacteria – maximum”.

Helicobacter, according to the doctors, provoking the emergence of such problems with the stomach, as ulcer and gastritis. To treat these diseases should be strictly under the supervision of a physician, said the researchers. Self-treatment may play a fatal role in the occurrence of cancer, the experts warned. 8 million people die because of cancer of the stomach in connection with their own negligence, as not timely appealed to the doctor, say data scientists.

Scientists reported that the areola habitat of H. pylori in the human body is very extensive: covering bacteria found in teeth plaque and saliva.

“Therefore, even a simple kiss can serve as a shock mechanism to cancer development,” said the experts.
Earlier Magicforum wrote about how the surface in the plane containing the largest accumulation of dangerous bacteria and microorganisms.

Transfusion of young blood restores damaged liver

Experts Huajumbaro University of science and technology in China has received confirmation of the therapeutic effect of the transfusions of young blood plasma. In particular, it became clear what the transfusion triggers mechanisms of accelerated liver regeneration after injury.

In a press release on EurekAlert! it is the opinion of the researchers that plasma transfusions of young blood helps to restore the liver after ischemia-reperfusion. This condition is very dangerous for a man: thus there is violation of blood supply of the liver, caused as consequences of the surgical intervention, and shock States (hypovolemic, hemorrhagic, traumatic, burn, septic shock).

Scientists have conducted an experiment with three groups of rats. In the first group of animals received injection of young blood plasma, the second plasma old blood. The third group was a control. In all three groups of rats subjected to as ischemia-reperfusion.
The results of the experiment were as follows. In the first group, where animals received injections of young blood plasma, the liver has recovered after the breach much faster.

Scientists admit that the method of plasma transfusions of young blood might be useful for people.

Previously, the journal Nature published the findings of a study conducted by researchers from London studied whether blood transfusion to stop the aging process. The researchers came to the conclusion that I can’t, but at the same time they received evidence that such experiences may prevent the development of in the elderly life-threatening diseases such as cancer, heart disease, dementia.

Earlier Magicforum wrote that scientists were able to understand how high blood pressure causes the development of heart attacks and strokes.