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Tag: FDA

  • Inside The Push For Over-The-Counter Naloxone

    Inside The Push For Over-The-Counter Naloxone

    The FDA has recently taken an unprecedented step to kickstart the development of over-the-counter naloxone products. 

    Last week the FDA took an unprecedented step to make the anti-overdose drug naloxone directly available to opioid users.

    Currently, naloxone requires a prescription. But in an effort to make approval for non-prescription versions of the drug easier for pharmaceutical companies to get, the FDA developed sample labels that would meet federal Drug-Facts Label requirements for over-the-counter products. It marks the first time the drug agency has ever proactively created labelling to expedite the process.

    “Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority,” the agency wrote in an unsigned statement. “Increased availability of naloxone for emergency treatment of overdoses is an important step.”

    The agency created two model labels, one for a nasal spray version of the drug and one for an auto-injector version. Both versions include a short information box about the drug and its uses, followed by an illustrated guide on how to administer the life-saving treatment and a warning about the drug’s expected effects.

    “These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” the FDA wrote. The agency tested the labeling through a research contractor to verify that potential users could understand the images and warnings.

    “This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most,” the statement continued. “In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.”

    The move comes amid a long-term rise in overdose deaths, as close to 48,000 people died from opioids in 2017 – double what the figure was seven years earlier, according to the federal agency. Overdoses can cause drug users to lose consciousness and stop breathing, but naloxone reverses those effects if given quickly enough. 

    Though the injectable version is pricier, a two-pack of the brand-name nasal spray version sells for about $125, according to CNBC. The generic is around $40 per dose. In theory, offering up a label that could make over-the-counter access easier might help lower those figures further by eliminating the need for would-be buyers to spend money on seeing a doctor for a prescription.

    “While the person administering naloxone should also seek immediate medical attention for the patient,” the agency said, “the bottom line is that wider availability of naloxone and quick action to administer it can save lives.”

    View the original article at thefix.com

  • FDA Tries To Blame Kratom In Newborn Withdrawal Case

    FDA Tries To Blame Kratom In Newborn Withdrawal Case

    The agency claims it is aware of four other NAS cases involving infants exposed to kratom in utero.

    A new case report published in the journal Pediatrics suggests that kratom was the cause of a newborn’s withdrawal symptoms. While the Food and Drug Administration (FDA) and other naysayers of the herbal supplement say this is a prime example of kratom’s potential for abuse and addiction, researchers say there’s not enough information to draw any hard conclusions.

    According to the case report, a former oxycodone user gave birth to a boy who showed signs of drug withdrawal—he was jittery, screaming, and required a morphine treatment to stay alive.

    The mother reported that she had used oxycodone for almost a decade. But she completed a treatment program and was off the drugs during her pregnancy. Indeed, no opioids were detected in a drug test.

    According to the woman’s husband, she had kratom tea every day to treat her withdrawal symptoms and help her sleep. Kratom, a plant that is native to Southeast Asia, has a fierce and loyal following of people who say it has helped them manage pain and treat opioid withdrawal.

    But people should practice caution, says lead author of the case report Dr. Whitney Eldridge, a neonatologist at BayCare Health System in Florida. “I fear that women making genuine commitments to overcome their dependency may develop a false sense of safety by using a substance that is advertised as a non-opioid alternative,” she said.

    As CNN notes, there is no explicit link between kratom and neonatal abstinence syndrome (NAS) made in the case report.

    There is not enough information to do so, says Dr. Andrew Kruegel, associate research scientist at Columbia University. “The main limitation is that we don’t know anything about the dosage that the mother was taking. Without that information, you can’t really extrapolate too much.” Nor was it verified—other than from the husband’s account—that the substance the mother was ingesting was indeed kratom.

    According to the FDA, the boy’s case “further illustrates the concerns the FDA has identified about kratom, including the potential for abuse and addiction.”

    The agency claims it is aware of four other NAS cases involving infants exposed to kratom in utero.

    In April, FDA Commissioner Scott Gottlieb went so far as to state that “compounds in kratom make it so it isn’t just a plant—it’s an opioid.”

    View the original article at thefix.com

  • Psilocybin Trials For Depression Treatment Get Greenlight From FDA

    Psilocybin Trials For Depression Treatment Get Greenlight From FDA

    The FDA has recognized the psychedelic compound’s therapeutic potential.

    The U.S. Food and Drug Administration has granted its “Breakthrough Therapy” designation to psilocybin-assisted treatment for depression.

    By giving psilocybin research its “Breakthrough Therapy” designation, the FDA is expediting the development and review of psilocybin—the psychedelic compound in “magic mushrooms”—based on the results of preliminary clinical trials that demonstrate its potential to perform better than available treatments.

    Previous research on psilocybin has yielded promising results for treating end-of-life anxiety and depression, alcohol and tobacco use disorder and obsessive compulsive disorder.

    With the FDA’s blessing, the first large-scale clinical trial for treating refractory (treatment-resistant) depression with psilocybin will run for about one year in Europe and North America.

    Psilocybin researchers say this is a significant development in the future of the psychedelic compound’s role in medicine.

    “FDA Breakthrough status is a big deal,” Matthew Johnson, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins University, told Inverse. “It implies that the FDA recognizes the treatment is potentially one with a large impact on a largely under-treated condition.”

    Johnson and his colleagues recommend that the federal government re-categorize psilocybin to Schedule IV, instead of its current place in Schedule I, the category reserved for drugs defined as having a high potential for abuse and no medical value.

    In Schedule IV, psilocybin would instead be in the same category as Xanax and Ambien. The scientists say that while there’s less of a risk for harm than heroin (Schedule I), “that doesn’t mean [psilocybin is] safe, and they certainly need to be regulated in some fashion.”

    But while the FDA’s Breakthrough designation suggests that psilocybin is closer to mainstream acceptance than ever, it’s unlikely that the potential treatment will be widely distributed to the general population.

    Roland Griffiths, PhD, another prominent psilocybin researcher and a colleague of Johnson’s, says, “It seems unlikely that these are compounds that will be dispensed at a pharmacy.”

    “This is a significant positive development in the potential future regulatory approval of psilocybin, a classic psychedelic drug, for medicinal purposes,” Griffiths told Inverse.

    “After a decades-long hiatus of research with psilocybin and related psychedelic drugs, investigators in the United States and Europe have demonstrated the safety and preliminary signs of efficacy of psilocybin for a variety of therapeutic applications.”

    View the original article at thefix.com

  • New Opioid 500 Times Stronger Than Morphine Nears FDA Approval

    New Opioid 500 Times Stronger Than Morphine Nears FDA Approval

    Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances.

    The chair of an FDA advisory panel is speaking out against the approval of a powerful new opioid that is even stronger than fentanyl, but despite his public stances it appears likely that the FDA will approve the drug. 

    “Opioids are substantially different than almost any other classification of drugs in that they carry with them the risks of tolerance, addiction, and death, and what we’ve been trying to get the FDA to come to grips with is that this class of drugs needs to be treated differently,” Raeford Brown, Jr., MD, chair of the Anesthetic and Analgesic Drug Products Advisory Committee and professor at the University of Kentucky told MedPage Today. “Some of the methodology they use to manage other drug classes are perhaps not reasonable with this.”

    The drug in question is DSUVIA, a form of sufentanil, a synthetic opioid that is 500 times more powerful than morphine. Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances, but DSUVIA would make it available in a tablet that is administered under the tongue.

    On Oct. 12, the FDA’s advising committee voted 10-3 to allow the drug to go to market. 

    However, Brown said that many committee members — himself included — were absent for that vote because they were attending the American Society of Anesthesiologists conference.

    “That’s one of the reasons I felt that I needed to speak up, because people that are regulating this drug need to be very thoughtful about the public health in this particular circumstance,” he said.

    The drug would be approved with a Risk Evaluation and Mitigation Strategy (REMS) program, but Brown said that is not enough of a safeguard. 

    “There’s no indication whatsoever that any of the REMS programs for opioids have been effective in improving the safety,” he said. 

    Brown is so against the approval of DSUVIA that he penned an open letter to the FDA, saying that sufentanil has “substantial risks of respiratory depression, diversion, abuse, and death,” and that its benefits do not outweigh these risks.  

    “It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote. “Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”

    Further information on the approval of DSUVIA is expected in early November. 

    View the original article at thefix.com

  • Will Naloxone Be Co-Prescribed With Opioid Painkillers In The Future?

    Will Naloxone Be Co-Prescribed With Opioid Painkillers In The Future?

    While some states already require the co-prescription, the FDA is considering making it a requirement across the US.

    In an effort to decrease overdose deaths, doctors could soon be required to prescribe an opioid overdose antidote any time they prescribe prescription painkillers, according to Food and Drug Administration (FDA) Commissioner Scott Gottlieb.  

    The idea of co-prescription, according to the Washington Examiner, isn’t a new idea. In fact, some states such as Arizona, Virginia, and Vermont, already require the co-prescription of the overdose reversal drug known as naloxone.

    Naloxone comes in the form of a nasal spray as well as an auto-injection so it may be administered by those not in the medical field.  

    Other states considering such laws include California, Florida, New York, Ohio, Texas, and Utah. 

    Such laws are supported by the manufacturers of popular overdose antidotes, such as Adapt Pharma, the company that distributes Narcan. 

    “We are trying to do anything we can to build awareness and broaden support,” said company chairman and CEO Seamus Mulligan, according to the Examiner. 

    Kaleo, the manufacturer of the naloxone auto-injector, is also supportive, telling the Examiner in May that it “welcomes” the idea of co-prescribing.

    “We believe that doctors, pharmacists and other healthcare professionals play a critical role in developing and managing a comprehensive treatment plan for their patients, as well as helping a patient and their loved ones recognize the potential risk for opioid emergencies, even when pain medications are taken as directed,” the company said.

    Current laws vary from state to state. In Vermont, prescription rules are connected to other laws requiring doctors to check patient databases before prescribing an opioid.

    In Virginia, it’s recommended that high doses of pain prescriptions are given with an overdose antidote prescription as well.

    Additionally, doctors are encouraged to prescribe the antidote when prescribing opioids and benzodiazepines, as the two can lead to overdose.

    The Centers for Disease Control and Prevention (CDC) has made similar recommendations in its guidelines to doctors. 

    While naloxone can save lives, it’s not considered a treatment for substance use disorder. 

    “Naloxone allows someone another day to have an opportunity to overcome their addiction,” New York state Sen. George Amedore Jr. said, according to the Examiner. “It’s not the whole answer or the cure-all.”

    As such, some officials are also calling for wider access to buprenorphine, a medication that helps to lessen cravings and withdrawals. 

    The FDA will hold a meeting on Dec. 17-18 to determine more ways to make the overdose antidote more readily available. 

    View the original article at thefix.com

  • FDA May Ban Flavored E-Cig Products From Convenience Stores

    FDA May Ban Flavored E-Cig Products From Convenience Stores

    If the ban becomes a reality, places like 7-Eleven, Circle K, Shell and Mobil would no longer carry flavored e-cig products.

    Continuing its crusade to push back on “epidemic” levels of young people vaping, the FDA is now considering whether flavored e-cigarette products should be limited to being sold in vaping shops.

    This would mean that convenience stores and gas stations like 7-Eleven, Circle K, Shell and Mobil would no longer carry flavored e-cig products.

    These four merchants were caught up in a nationwide undercover sweep over the summer that resulted in 1,300 warning letters from the FDA to retailers illegally selling e-cigarette products to minors.

    “We’re looking at what can be sold in brick-and-mortar stores and whether or not flavored products can be sold in regular stores like 7-Eleven and a truck stop and a gas station, or whether or not flavored products on the market should be confined to adult vaping shops, which generally tend to do a better job of checking ID,” said FDA Commissioner Scott Gottlieb in a recent interview.

    The FDA has been cracking down on e-cigarette makers and merchants based on the concern that vaping is becoming too accessible to middle- and high-schoolers.

    According to federal figures cited by Gottlieb, in 2017, use of e-cigarettes among high schoolers increased by 77%, and by 50% among middle schoolers.

    “We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” said Gottlieb in September news release. “We cannot allow a whole generation to become addicted to nicotine.”

    At that time, the FDA requested that five major e-cigarette brands—Juul, Vuse, MarkTen, Blu and Logic—submit plans to “immediately and substantially reverse these trends” of young people vaping.

    They were warned that if they do not comply within 60 days, the agency may require the companies to “revise their sales and marketing practices, to stop distributing products to retailers who sell to kids and to stop selling some or all of their flavored e-cigarette products until they clear the application process,” CNBC reported at the time.

    In the recent interview, Gottlieb said that so far the FDA has met with Juul, Altria (MarkTen) and Reynolds (Vuse).

    View the original article at thefix.com

  • E-Cig Maker Called Out For Putting Erectile Dysfunction Meds In Vape Juice

    E-Cig Maker Called Out For Putting Erectile Dysfunction Meds In Vape Juice

    The FDA issued a warning to one e-cig maker that reportedly violated the Food, Drug, and Cosmetic Act.

    The FDA is casting a closer eye on HelloCig Electronic Technology, an e-cigarette manufacturer, after FDA researchers discovered that not only were the fruit-flavored products found to impair lung function in trials on mice, but the liquids contained prescription erectile dysfunction drugs as well.

    While e-cigarettes, vapes, and their ilk have been touted as a healthier alternatives to smoking for years, the truth is that the products were simply too new to allow any deep understanding about the possible adverse risks they carry as well as what product regulations should be put in place to protect consumers.

    This lack of regulation may have contributed to HelloCig’s inclusion of tadafil and sildenafil, usually used as the active ingredient to treat erectile dysfunction, in their e-cigarette liquids.

    “There are no e-liquids that contain prescription drugs that have been proven safe or effective through this route of administration,” said Scott Gottleib, FDA Commissioner.

    The FDA also undertook a surprise inspection of popular San Francisco e-cig manufacturer Juul, snatching up their marketing documents to ensure the company is not marketing to minors. Juul has been a runaway success, seeing a massive increase in sales from 2.2 million devices in 2016 to 16.2 million devices in 2017.

    Considering that 2 million high schoolers reported using e-cigarettes in a National Youth Tobacco Survey study, a significant portion of these sales made their way to the hands of minors.

    That’s why last September, the FDA warned and fined any e-cig manufacturers found to have sold products to minors and gave them 60 days to prove they had mechanisms in place to prevent minors from purchasing their products.

    The fruity flavors that are most attractive to teens have been linked to impaired lung function in mice. While this does not necessarily mean that the same effects will be seen in humans, it’s an important first step to determining the risks the products present.

    “Our findings suggest that exposure to e-cig vapor can trigger inflammatory responses and adversely affect respiratory system mechanics,” wrote the study’s authors. “We conclude that both e-cig vaping and conventional cigarette smoking negatively impact lung biology.”

    Groups of mice were exposed to cigarette smoke as well as different formulations of e-cigarette vapor. After three days, all the mice were found to have problems with inflammation, mucous production, and lung function.

    View the original article at thefix.com

  • New Dosage Strength Of Opioid Addiction Drug Approved By FDA

    New Dosage Strength Of Opioid Addiction Drug Approved By FDA

    The FDA commissioner noted that the approval will expand access for patients and reduce drug development costs.

    The U.S. Food and Drug Administration (FDA) approved a new dosage strength for a maintenance drug for the treatment of opioid addiction.

    Cassipa, which is a sublingual (applied under the tongue) film that combines the opioid treatment drug buprenorphine and the opioid overdose reversal drug naloxone, will now be available in a 16 milligrams/4 milligrams dosage, and according to FDA Commissioner Scott Gottlieb, should be used in conjunction with counseling and therapy.

    The new dosage strength is approved by the FDA in both brand name and generic versions, and in various strengths.

    The approval underscores the agency’s emphasis on greater development of and access to medication-assisted treatment (MAT) for substance use disorder. The full range of MAT is a key element of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, and was the focus of guidelines issued to drug manufacturers for evaluating the effectiveness of new or existing MAT products. 

    In a statement issued in April 2018, Gottlieb described the FDA-approved MAT drugs—methadone, buprenorphine and naltrexone—as “safe and effective in combination with counseling and psychosocial support to stabilize brain chemistry [and] reduce or block the euphoric effects of opioids.”

    The FDA has also cited statistics from the Substance Abuse and Mental Health Services Administration (SAMHSA), which found that patients using MAT for opioid dependency have reduced their chance of overdose death by half.

    In addition to its suggested efficacy for opioid use disorder, Gottlieb noted that newer treatment options like the increased dosage strength for Cassipa will not only “broaden access for patients,” but may also “reduce drug development costs, so products may be offered at a lower price to patients” via the agency’s “streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine.”

    This approach is the abbreviated 505(b)(2) pathway under the Federal Food, Drug and Cosmetic Act, which allows manufacturers to use the FDA’s findings regarding the safety of their product to grant approval.

    The FDA is advising that Cassipa should be used in conjunction with a complete treatment plan that includes counseling and other support, and should only be used after the patient is introduced to the drug and stabilized up to a dose of 16 mg of buprenorphine using another marketed product. Additionally, Cassipa can only be prescribed by Drug Addiction Treatment Act-certified prescribers.

    View the original article at thefix.com

  • FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic

    FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic

    Around 1,300 warning letters have been sent to retailers of e-cigarettes found to be illegally selling e-cigarette products to minors.

    The Food and Drug Administration, concerned about the rising numbers of teenagers who “vape,” is cracking down on major e-cigarette brands to try and stop this trend.

    In a press release issued on Wednesday (Sept. 12), the FDA announced that it is requesting major brands—JUUL, Vuse, MarkTen, Blu, and Logic—to submit plans to “immediately and substantially reverse these trends” of young people vaping.

    If they do not comply within 60 days, the agency “may require the companies to revise their sales and marketing practices, to stop distributing products to retailers who sell to kids and to stop selling some or all of their flavored e-cigarette products until they clear the application process,” according to CNBC.

    The latest crackdown is the result of a nationwide undercover sweep over the summer. Since then, 1,300 warning letters have been sent to retailers of e-cigarettes found to be illegally selling e-cigarette products to minors.

    The vast majority of the violations were for the illegal sale of JUUL, Vuse, MarkTen, Blu and Logic—which account for over 97% of the U.S. e-cigarette market.

    Initially, e-cigarettes were touted as a less harmful alternative to traditional cigarettes for people who want to quit. But growing use among young people is now a concern for the FDA.

    “In enabling a path for e-cigarettes to offer a potentially lower-risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products,” said FDA Commissioner Scott Gottlieb in the press release.

    “We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” Gottlieb declared, going on to say that promoting smoking cessation can’t come “at the expense of kids.”

    “We cannot allow a whole new generation to become addicted to nicotine,” he added.

    In the coming weeks, the FDA said it will take additional action under its Youth Tobacco Prevention Plan, and ramp up enforcement of the illegal sale of these products to kids.

    View the original article at thefix.com

  • Stop Illegally Selling Opioids Online, FDA Warns

    Stop Illegally Selling Opioids Online, FDA Warns

    Over the summer, the FDA has issued similar warnings to 70 websites. 

    The Food and Drug Administration issued a warning this week to the operators of 21 websites that the administration says sell mislabeled and illegal opioids to Americans. 

    The websites, which are run by four companies, have been “illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol,” according to a press release issued by the FDA on Tuesday (August 28). 

    “The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice,” FDA Commissioner Scott Gottlieb said in the news release.

    Over the summer, the FDA has issued similar warnings to 70 websites. 

    “The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health,” Gottlieb said. “We have more operations underway, and additional actions planned. We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.”

    People who buy their opioids online can often wind up with expired, counterfeit or contaminated pills, according to the FDA. Some of the pills are marketed under one name, but are really just pressed fentanyl, a dangerous synthetic opioid. On CNBC’s Squawk Box, Gottlieb said that online sales are making the ongoing opioid crisis worse.

    “As we see doctors prescribe fewer opioids, we’re fearful that more and more of the new addiction is going to shift to illicit sources, and a lot of those illicit sales are taking place online,” he said on Tuesday.

    The four companies that received warnings on Tuesday were CoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics. They have 10 days to respond to the FDA’s letter, outlining the specific actions that they will take to avoid selling illegal opioids to Americans. If the companies do not respond they may face legal action. 

    On Wednesday, Gottlieb said that the FDA will continue to aggressively pursue companies and practices that make opioids too easily available. 

    “The reason that we find ourselves with a crisis of such proportion is that as a medical profession, we’ve been one step behind its sinister advance,” he said in a press release.

    “Collectively, we didn’t take all the steps we could, when we could, to stop the advance of this crisis. We shunned hard decisions. As a profession, providers were too liberal in our use of these drugs well past the point where there were signs of trouble, and the beginning of a crisis of addiction. I’m committed to making sure that we don’t perpetuate these mistakes of the past. And so, when we see this crisis taking new twists and turns, we’ve acted swiftly.”

    View the original article at thefix.com