Answer Addiction

Tag: FDA

  • Misuse Of Unapproved Antidepressant With Opioid-Like Effects Spikes

    Misuse Of Unapproved Antidepressant With Opioid-Like Effects Spikes

    Though tianeptine isn’t FDA-approved, it’s not illegal and can be purchased online as a dietary supplement.

    An apparent spike in the use of an unapproved antidepressant called tianeptine is poisoning people who are looking to benefit from the drug’s mild opioid-like effects, according to a Centers for Disease Control and Prevention (CDC) report released last week.

    From 2000 to 2013, the U.S. saw 11 tianeptine-related poison control center calls; from 2014 to 2017, there were more than 200. That’s all according to the CDC analysis of National Poison Data System information, which sheds new light on a growing trend.

    Though tianeptine isn’t FDA-approved, it’s not illegal and can be purchased online as a dietary supplement. It’s often marketed elsewhere under brand names Coaxil and Stablon, according to Vice News.

    The drug was first discovered by the French Society of Medical Research back in the 1960s, and it’s been shown to help fight depression and anxiety, according to CNN.

    When it was patented, scientists weren’t entirely clear on how it worked. But in 2014, researchers found that the drug lights up certain opioid receptors. While that appears to help with some depression symptoms, it also means that people taking tianeptine can have opioid-like withdrawal when they stop taking the drug.

    “Tianeptine has an abuse potential in former opiate drug users,” the CDC researchers wrote. “This study further highlights that the withdrawal effects of tianeptine mimic those of opioid withdrawal.”

    But, unlike with traditional opioids of abuse, tianeptine doesn’t show up on drug screens, which can make it a tempting choice for justice-involved individuals looking for a high that won’t land them in legal hot water.

    “I think people have this misguided belief that if you can get it on the internet and it’s not overtly illegal and you’re not going through the dark web to acquire these substances, so it must be OK,” Raphael Leo, an associate professor in the Department of Psychiatry at the University of Buffalo, told CNN.

    But, earlier this year, the Journal of Analytical Toxicology reported on two tianeptine-related deaths in Texas, and more have been reported in other countries.

    The potential dangers of the unapproved drug have sparked some calls to ban it. In April, Michigan greenlit a law banning the substance on the heels of a number of overdoses, according to the Associated Press.

    View the original article at thefix.com

  • FDA Warns Of Synthetic Marijuana Laced With Rat Poison

    FDA Warns Of Synthetic Marijuana Laced With Rat Poison

    The warning comes amid a wave of synthetic marijuana overdoses. 

    The FDA warned this week about the ongoing danger of synthetic cannabis laced with rat poison, floating concerns that the tainted drug could pose a threat to the nation’s blood supply. 

    Poisoned supplies of the drug have already accounted for several deaths and sent hundreds of users to the hospital this year with severe bleeding or seizures, officials said. 

    Concern about contaminated drug stashes comes amid an ongoing effort to stamp out the use of the cannabis copycat often sold illegally in convenient stores and corner markets. The Centers for Disease Control and Prevention raised a red flag about the risks of rat poison-laced supplies earlier this year. 

    “Despite our efforts, certain entities continue to bypass state and federal drug laws by making and distributing these products – often marked or labeled as ‘not for human consumption’ – and changing the structure of the synthetic chemicals to try to skirt legal requirements,” the FDA wrote in its release. 

    But the real danger in recent months, the agency said, is that K2 makers have begun adding in brodifacoum – an anticoagulant used in rat poison – in an effort to prolong the high. 

    Adding that chemical can pose other health risks, including severe bleeding. Hundreds of users across 10 Midwestern states have been hospitalized in recent months as a result of complications stemming from the presence of brodifacoum, the agency said. 

    “Today, we’re joining together to send a strong warning to anyone who may use synthetic marijuana products that these products can be especially dangerous as a result of the seemingly deliberate use of brodifacoum in these illegal products,” the agency wrote in a release Thursday. 

    Aside from the risk to users, the agency also highlighted the threat to the blood supply. 

    “The FDA has received several reports of donors who used synthetic cannabinoids contaminated with brodifacoum. Because of its long half-life, the bleeding risk from brodifacoum, which prevents vitamin K from being reused within the body, can persist for weeks,” the agency wrote.

    “Given the known and unknown risks associated with these synthetic cannabinoid products, the FDA urges individuals to avoid using them, especially since there’s no way of telling which synthetic marijuana products have been contaminated with the powerful anticoagulant brodifacoum.” 

    The agency vowed to continue monitoring the situation, along with the CDC and DEA.

    View the original article at thefix.com

  • FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    The FDA commissioner issued a statement addressing the stigma aimed at pain patients and the need for providers to take a patient-centric approach.

    Strict opioid prescribing regulations are harming some chronic pain patients, according to U.S. Food and Drug Administration Commissioner Scott Gottlieb.

    On Monday, July 9, the FDA released a statement about its Patient-Focused Drug Development Meeting, during which Gottlieb brought up the struggles some patients face because of strict opioid prescribing laws. 

    According to PatientEngagementHIT, there are some instances in which patients, such as those those facing “metastatic cancer pain management and chronic migraine management,” are best fit for a long-term opioid prescription.

    “Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide,” Gottlieb said in the statement. “This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies.”

    While Gottlieb acknowledges that prescribing regulations are necessary in order to fight the opioid crisis, he also says those strategies are negatively affecting patients who rely on the medications for pain management.

    Gottlieb and his colleagues have learned through patient workgroups that patients in need of pain management say they feel stigmatized and have a difficult time building healthy relationships with care providers.

    According to Gottlieb, simply banning opioids or increasing the difficulty of obtaining a prescription is not the solution to the issue. He says instead, better education needs to be available to providers and opioid prescribing should take a “patient-centric” approach, taking patient “preferences, needs, and patient education approaches” into account.

    “Balancing the need to maintain access with the mandate to aggressively confront the addiction crisis starts with good medical management,” Gottlieb said in the statement. “All patients in pain should benefit from the skillful and appropriate care of their pain. It’s also critical that we take this same aggressive approach to changing the culture of medicine around treating pain… Patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions.”

    The statement also outlines steps the FDA has taken to push responsible prescribing methods. For example, the FDA released a blueprint for drug manufacturers focusing on how they can educate prescribers. Additionally, the FDA is working with medical professionals to develop resources for clinicians.

    “We need to be mindful of this history, learn from it and make sure that we act aggressively to confront new trends that may continue to fuel the current crisis or lead to a new epidemic of addiction,” Gottlieb explained.

    The FDA also stated that combating the opioid crisis should not involve limiting or banning opioids, but instead has to do with better education about practices.

    “Our goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids,” Gottlieb said in the statement. “In this way, we’ll help ensure that we’re not unnecessarily putting patients as risk of addiction by overprescribing opioids, while also maintaining appropriate access to care for patients with serious pain. In pursuing these goals, we must make sure that patients inform our work.”

    View the original article at thefix.com

  • Frustrated Pain Patients Meet With FDA About Opioid Access

    Frustrated Pain Patients Meet With FDA About Opioid Access

    A group of pain patients met at FDA headquarters to share their personal stories in a bid to get the agency to ease opioid restrictions.

    The FDA called a meeting in Washington, D.C. to listen to pain patients’ experiences of lacking access to opioids to manage their symptoms.

    A group traveled to the FDA’s headquarters outside the nation’s capital to ask the agency to ease restrictions that they say has made it harder for them to obtain opioids.

    NBC News reported on the stories of some of those who urged the FDA to consider what it is like to have acute or intractable pain and be unable to find relief.

    Dr. Sharon Hertz, director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, told NBC of the informal meeting, “We don’t have expectations for what we are asking. If we thought we knew, we wouldn’t be asking.”

    The Patient-Focused Drug Development Meeting included harrowing stories of suffering. Sandra Flores has a condition called adhesive arachnoiditis, which is an inflammation of membranes in the brain, spine and nerve endings. She has repeatedly attempted to obtain the correct drugs for her pain.

    “I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”

    FDA Commissioner Scott Gottlieb made an emphatic statement on the plight of pain patients without access to relief. 

    “Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide. This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies,” said Gottlieb, according to PatientEngagementHIT.

    The FDA does not regulate physicians’ prescribing habits; states do. As of now, 28 states enforce limits on opioid prescriptions, says data from the National Conference of State Legislatures.

    Although the FDA, CDC and most major medical institutions agree that limiting access to opioid prescriptions is a necessary step in fighting the opioid epidemic, they do not want intractable pain patients to suffer.

    Under the new regulations, many doctors have simply stopped prescribing out of fear of lawsuits. Flores has been unable to find a doctor that will take her on as a patient. “No doctors will fight. They just don’t want to get into trouble. They have forgotten the people that these drugs were made for.”

    Rose Bigham, speaking on behalf of the Alliance for the Treatment of Intractable Pain, said in the Washington meeting, “To the FDA—we are begging you. Correct the CDC’s egregious mistakes. The CDC recommendations have done irreparable harm to people in pain.”

    View the original article at thefix.com

  • Kratom Supporters Converge on Washington to Fight Potential Ban

    Kratom Supporters Converge on Washington to Fight Potential Ban

    Kratom advocates met at the U.S. Capitol in early June to begin a week of lobbying in favor of the substance.

    With a federal ban on kratom gaining traction in Washington, D.C, advocates of the plant’s pain management and potential opioid withdrawal properties traveled to the nation’s capital to lobby support for the Southeast Asian plant.

    Participants hoped to correct legislators’ misconceptions about the plant, which has been labeled as an equivalent to prescription opioids with no medical benefit by the U.S. Food and Drug Administration (FDA).

    But as the Huffington Post noted, supporters found that their efforts generated a mixed response from the House and Senate, where legislative aides reportedly said that if the FDA followed through with the ban, it would most likely receive backing from the Drug Enforcement Administration (DEA).

    Surveys have suggested that between three and five million Americans use kratom, which is consumed as a supplement made from the dried or powdered leaves of the kratom tree.

    Users claim that kratom can serve as a stimulant or sedative, and it has been touted as an alternative to prescription opioids for pain management, and in some cases, as a potential tool for withdrawal from opioids. It is currently unregulated in America, though some states have enacted a ban on the substance within their own borders.

    Kratom’s interaction with opioid receptors in the body has placed it in the crosshairs of the FDA, which has claimed that it can impact the user in the same manner as opioids, and has the same potential for abuse and dependency.

    The agency’s negative press eventually spurred the DEA’s decision to temporarily add kratom to its list of Schedule I drugs in 2016, though public outcry from users who relied on the substance for their quality of life forced it to rescind its order that same year.

    The FDA has since renewed its efforts to take kratom off the market, this time with computer analysis that suggested the most prevalent compounds in the substance share “structural similarities” to opioids. It also officially recommended that the DEA move forward with its rescheduling, a decision which, according to sources within the agency, may happen as early as summer 2018.

    In hopes of heading off such measures, kratom advocates met at the U.S. Capitol on June 5 to begin a week of lobbying in favor of the substance. Proponents testified to the positive impact of kratom use on their chronic pain, which they claimed to have treated unsuccessfully with prescription opioids.

    As the HuffPost article noted, one individual spoke about her anxiety that had driven her to consider suicide, and how she had found relief through kratom use.

    But attendees also reported that meetings with legislative aides at the House and Senate could not generate a concrete statement of support. Most appeared to hear and support the advocates’ aims, but could not assure the visitors that they would work on their behalf; others stated that if the FDA wanted to reassign kratom, there would be little they could do to stave off or reverse that decision.

    “They were pretty much letting us know that this isn’t looking too great,” said Melanie Victor, a volunteer from Tennessee. “This is probably going to be a pretty big fight.”

    View the original article at thefix.com

  • Generic Suboxone Strips Get The Green Light

    Generic Suboxone Strips Get The Green Light

    The FDA’s move could mean wider availability and more competitive pricing for the popular addiction-fighting drug. 

    The FDA last week sparked a flurry of legal wrangling when it gave the go-ahead for two drugmakers to sell generic versions of Suboxone strips.

    Part of an agency push to expand access to medication-assisted treatment, the move could open up the door to more competitive pricing for the popular addiction-fighting drug—but it also turns up the heat in an ongoing battle between drug companies intent on protecting profits. 

    “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them,” Commissioner Scott Gottlieb said in a statement. “That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”

    Currently, the brand-name under-the-tongue strips are sold by Indivior and cost around $200 per month without insurance. The British company is already embroiled in litigation over claims that it strategically worked to block competition from generic Suboxone in order to maintain soaring profits. At one point, the drug brought in $2 billion in sales a year, according to FiercePharma.

    But now, the Pennsylvania-based drug maker Mylan and the India-based company Dr. Reddy’s both have the green light to bring out generic versions of the drug. Mylan did not immediately comment on the approval or its plans moving ahead, but the Hyderabad competitor issued a statement Friday praising the move and detailing its 2 mg, 4 mg, 8 mg and 12 mg formulations.

    “With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” said Dr. Reddy’s CEO Alok Sonig. 

    But Indivior took the matter straight to the courthouse and on Friday—just a day after the FDA announcement—the company won a temporary restraining order blocking Dr. Reddy’s from moving forward with its product release in light of ongoing patent litigation. A judge will decide on the path ahead at a June 28 federal court hearing in New Jersey. 

    Indivior CEO Shaun Thaxter put out a statement expressing surprise at his competitor’s decision to launch the generic drug—and promised to keep up the courtroom fight.

    “We will continue to pursue all legal avenues, including an immediate injunction until the legal status of our intellectual property is confirmed by the courts,” he said.

    And Mylan won’t necessarily have an easier time pushing out its generic formulation of the medication-assisted treatment, as the company had previously agreed to delay its generic launch until 2023.

    Suboxone, which combines naloxone and buprenorphine to ease withdrawal and fight cravings, initially hit the U.S. market in 2002 as a pill. Five years later, Indivior announced plans to launch a sublingual film, a formulation that wouldn’t immediately have a generic alternative. 

    But in 2016, 35 states joined together to sue the company for anticompetitive practices. The states claimed that Indivior raised unfounded safety concerns to delay the FDA’s approval of the generic Suboxone tablet. Then, the company allegedly used those concerns to push strips over pills, a move that the states alleged was intended to prevent patients from taking generic versions of the pill. 

    The Federal Trade Commission (FTC) has since been investigating the company over antitrust claims, according to reports. 

    Whatever the legal drama surrounding the drug approvals, the FDA framed its announcement as an important step toward increasing access to lifesaving treatments and reducing stigma around medication-assisted treatments.

    “The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction,” Gottlieb said. “When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”

    View the original article at thefix.com

  • New Generation Of Antidepressants On FDA Fast Track

    New Generation Of Antidepressants On FDA Fast Track

    The medications, which are still in development, may be able to help those who have not found success with currently available antidepressants.

    Pharmaceutical companies are honing in on the potential of ketamine and more to provide fast-acting antidepressant relief, Healthline reports.

    Two examples are Janssen Pharmaceuticals’ esketamine nasal spray and Allergan’s rapastinel (a different, but similarly-acting antidepressant to ketamine), both which the FDA has granted fast-track approval.

    On May 5, Janssen (a subsidiary of Johnson & Johnson) announced findings from Phase 3 trials of its esketamine nasal spray. The study administered esketamine (a close relative of ketamine) to adults with treatment-resistant depression, in addition to a “newly initiated oral antidepressant,” and discovered a “statistically significant, clinically meaningful rapid reduction of depressive symptoms” compared to the placebo.

    According to a Johnson & Johnson press release, the yet-to-be-approved esketamine nasal spray has the potential to address a “significant unmet need for the more than 30% of people suffering from major depressive disorder who do not respond to… currently available antidepressants.”

    Ketamine is typically administered as a veterinary anesthetic, but off-label use of the drug has become more popular for pain, post-traumatic stress disorder (PTSD), anxiety and depression, according to CNN.

    The initial findings of Johnson & Johnson’s research, reported by the BBC in April, found that the nasal spray led to “significant” improvements in depressive symptoms in the first 24 hours. By 25 days, the effects had waned, the report noted, but this does not detract the drug’s potential value as a rapid antidepressant treatment to initiate therapy, said the study’s authors.

    Another potential new antidepressant on the fast track for FDA approval is rapastinel, developed by Allergan. Currently the drug has completed Phase 2 trials and is expecting the results of its Phase 3 trials in 2019, according to Healthline.

    These “rapid-acting therapies” have the potential to be “game-changing in the treatment of depression,” said Allergan executive vice president and chief research and development officer David Nicholson, PhD, in a statement to Healthline. He continued, “Our studies so far demonstrated rapid onset of efficacy within one day, which lasts days after a single dose and a low potential for abuse.”

    Another recent report opens even more possibilities for alternative antidepressant therapies. New research demonstrated that psychedelics (specifically LSD, DMT, MDMA and DOI, an amphetamine) showed positive effects on neural plasticity, meaning that neurons were more likely to branch out and connect with one another.

    Ketamine is said to have the same effect.

    This is a positive development for people living with depression, anxiety, substance use disorder, and PTSD, since research has shown that their brain plasticity and neurite growth are less active.

    View the original article at thefix.com

  • FDA Challenges Developers To Make Better Pain Treatment Devices

    FDA Challenges Developers To Make Better Pain Treatment Devices

    For an innovation challenge, the FDA is looking for devices that provide more benefits than opioids, with fewer risks. 

    The Food and Drug Administration wants better options available for treating pain—and it is turning to developers for help. 

    The FDA announced this week that it is running a new innovation challenge for medical devices that provide solutions to detecting, treating and preventing addiction, addressing drug diversion and treating pain.

    Applications will be accepted through September, and the developers of devices that are chosen will be able to work closely with the FDA to bring their product to market. 

    “Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D. 

    Gottlieb hopes that by encouraging the development of medical devices, fewer patients will need to rely on opioid pain relief, which has a high risk of addiction. 

    “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids,” he said. 

    Finding replacements for opioids is an important piece of confronting the opioid epidemic, he added. 

    “This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction,” he said. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”

    Developers can submit devices that are in any stage of development, including the concept phase. The FDA will be looking for devices that provide more benefits than opioids, with fewer risks. 

    In 2012, the FDA ran a similar innovation challenge that helped develop and bring to market new ways of treating renal disease, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. He hopes this challenge will have similar results. 

    “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” he said. “We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”

    View the original article at thefix.com