Tag: esketamine

  • Veterans Affairs To Offer Ketamine-Based Nasal Spray For Depression Treatment

    Veterans Affairs To Offer Ketamine-Based Nasal Spray For Depression Treatment

    The recently approved drug is said to relieve symptoms of depression as well as suicidal ideation in a short timeframe. 

    Veterans Affairs officials are now allowing VA doctors to prescribe Spravato, a medically viable variation of ketamine, to service members who suffer from depression.

    The drug has been known to beat some symptoms of depression extraordinarily quickly—taking just a few short days, or hours instead of weeks. Suicidal thoughts have been seen to dissipate in a timeframe as short as 40 minutes.

    “That first skyrocket up was my first infusion,” said Matthew Ayo, a 23-year-old who underwent ketamine treatment. “I went from severe depression to no depression symptoms.”

    Doctors will be able to prescribe Spravato only if at least two other antidepressants have been tried and failed to produce results.

    “We’re pleased to be able to expand options for Veterans with depression who have not responded to other treatments,” said VA secretary Robert Wilkie.

    Of the United States’ 20 million veterans, an estimated 14%—or 2.8 million veterans—are diagnosed with depression. Of those veterans, one-third to one-half may suffer from treatment-resistant depression, which is why it was so critical to find something new and fast.

    “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process, including a robust discussion with our external advisory committees, were important in our decision to approve this treatment,” said Dr. Tiffany Farchione, acting director of the FDA’s Center for Drug Evaluation and Research Division of Psychiatry Products.

    Spravato isn’t without side effects, however—including sedation, blood pressure spikes, and dissociation, including feeling paralysis or out-of-body sensations. Ironically, misuse may lead to suicidal thoughts and behaviors. Hence, the FDA approved the drug for VA prescriptions with restrictions.

    Veterans approved for the treatment would use the nasal spray under medical supervision. Afterwards, medical staff would monitor the patient for two hours. The patient would have to return for two doses a week for the first month, and one dose every two or three weeks in the months following. To prevent potential misuse, there is no option for home treatment.

    Ketamine’s new role is a far cry from its former life as “Special K,” an anesthetic that saw use on the dance floor as well as the battlefield. In the latter usage, military medical staff found that those prescribed with ketamine for pain also had fewer symptoms of PTSD.

    View the original article at thefix.com

  • FDA Approves Ketamine-Derived Spray for Depression

    FDA Approves Ketamine-Derived Spray for Depression

    The newly approved esketamine nasal spray will be administered under a doctor’s supervision at approved and certified treatment centers. 

    Clearing the way for the first major change to depression treatment in decades, the FDA approved a ketamine-derived nasal spray that can be used to rapidly treat depression on Tuesday (March 5). 

    “Thank goodness we now have something with a different mechanism of action than previous antidepressants,” Dr. Erik Turner, who teaches psychiatry at Oregon Health & Science University, told The New York Times

    In recent years ketamine has garnered a lot of attention from the medical community because it quickly and effectively relieves depression and suicidal ideation. Ketamine treatments have become popular, but until now the drug, which is approved as an anesthetic, has been used off label. This means treatments are unregulated and not covered by insurance. 

    The medication approved this week is esketamine, which contains a part of the ketamine molecule. It was developed by Janssen Pharmaceuticals and will be sold under the name Spravato.

    Since up to a quarter of depression patients don’t get relief from current antidepressants, people in the mental health community are happy to see a new option for treatment. However, Turner and others are cautious in their excitement. 

    “I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away,” Turner said. 

    Under the FDA recommendations, esketamine will be used in conjunction with an established antidepressants. Patients will get treatment twice a week for four weeks, and then as needed.

    Although the nasal spray is non-invasive, it must be administered in a doctor’s office where patients can be observed for two hours. The use of esketamine could give patients fast relief from their symptoms, which is important since traditional antidepressants can take weeks to become effective. 

    Dr. Todd Gould, a psychiatrist at the University of Maryland School of Medicine who has done ketamine research, said that the potential for fast-acting relief is appealing, even if ketamine doesn’t completely revolutionize depression treatment. 

    “These are exciting times, for sure,” he said. “We have drugs that work rapidly to treat a very severe illness.”

    Vanderbilt University professor Steven Hollon agreed. 

    “We’ve had nothing new in 30 years, so if this drug is an effective way to get a more rapid response in people who are treatment resistant, and we can use it safely, then it could be a godsend.”

    The FDA fast-tracked esketamine’s approval process. Although the drug has been used safely as an anesthetic for decades, medical professionals will be carefully monitoring its use in the mental health space, researcher James Stone told Newsweek last year. 

    “Although ketamine is potentially a huge breakthrough in the treatment of depression, we still don’t know about the long-term safety, or about how to keep people well from depression without requiring regular ketamine dosing. Further studies are needed to address these questions.”

    View the original article at thefix.com

  • Club Drug Ketamine Nears FDA Approval for Depression Treatment

    Club Drug Ketamine Nears FDA Approval for Depression Treatment

    Ketamine can relieve the symptoms of depression, but it’s especially effective at reducing suicidal thoughts quickly, sometimes within 40 minutes.

    Within an hour of Matthew Ayo’s first ketamine infusion treatment, his mother looked at him and said “I have my son back.”

    Ayo, who is now 23, had been treated for depression, anxiety, and other mental disorders throughout his teens and early twenties. A little more than a year ago his psychiatrist recommended that he try ketamine infusion therapy. For Ayo, the results were immediate and life-changing. He shows off a graph charting his depressive symptoms: “That first sky-rocket up was my first infusion,” he said. “I went from severe depression to no depression symptoms.”

    A year later, Ayo has remained depression-free and has gone from needing 24 pills each day to just 6. He’s moved out of his family’s home, secured a job, and is social. Although he still gets panic attacks, he says he’s better able to handle them.

    “It helped with every aspect: anxiety, depression, psychosis,” Ayo said. “I know that’s not what it’s for, but in my case it changed everything.”

    Stories like Ayo’s are awe-inspiring. Anyone who has experienced depression or watched helplessly as a loved one tries medication after medication hoping to find relief knows that too often the current treatments for depression and other mental illnesses just don’t work. Against this backdrop, ketamine infusion therapy can seem like a miracle treatment. When it works, it works quickly and effectively, often causing a dramatic reduction in symptoms of depression. However, medical providers caution that while ketamine shows a lot of promise, there’s still a long way to go toward understanding how the drug should be used to treat mental health conditions.

    A Conceptual Leap

    Ketamine — also known as the club drug “Special K” or “K”— is a well-established anesthetic, used since the 1970s to sedate people for medical procedures. Because it is safe and effective, ketamine is used widely by the military. During the wars in Iraq and Afghanistan, doctors began noticing that soldiers who were given ketamine for anesthesia often had fewer symptoms of post-traumatic stress disorder (PTSD), according to Dr. Steven Mandel, president of The American Society of Ketamine Physicians.

    “It took a conceptual leap for people to really wrap their heads around that this anesthetic somehow was acting as a mood elevator,” Mandel said.

    Mandel has practiced as an anesthesiologist for decades, but also has a master’s degree in psychology. As he looked into the research on ketamine, he became convinced that it could benefit people with depression, anxiety, and trauma. In 2014, he opened the Ketamine Clinics of Los Angeles and began offering treatments directly to patients, including Ayo. Mandel says that in his patients, ketamine treatments relieve the symptoms of depression 83 percent of the time and stop suicidal ideation more than 90 percent of the time.

    “It almost sounds too good to be true,” he said.

    Like Mandel, the wider medical community has been impressed by ketamine’s potential for treating psychiatric disorders. Although the Food and Drug Administration had only approved ketamine for anesthesia, providers began to use it off-label in ketamine infusion therapy — an intravenous administration of the drug — to provide swift relief of depression symptoms. At the same time, pharmaceutical companies hurried to develop a ketamine formulation specifically for treating mental health conditions.

    The result is Esketamine, developed by Johnson & Johnson, a nasal spray based on ketamine that can be used to treat depression. On Tuesday, February 12th, an FDA expert panel recommended that Esketamine receive federal approval. If approved, the medication will be covered by many insurance plans. Currently, almost all patients must pay out-of-pocket for ketamine infusions, which cost thousands of dollars. Doctors are hopeful that this will change as insurance companies realize that even off-label ketamine treatments can reduce the medical costs for people with mental illness.

    Risk-Benefit Analysis

    Speaking to Mandel and his patients, it’s impossible not to feel excited about ketamine. However, other providers are more cautious in their optimism.

    “There are certain scenarios where ketamine makes a whole lot of sense, and there are certain scenarios where it’s very unclear what the role of ketamine should be,” said Dr. Nolan Williams, assistant professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center. “I think that the idea that ketamine is going to be a treatment for everyone chronically for their depression forever is not realistic.”

    Most providers still reserve ketamine treatments for people who have already tried more traditional treatments. While the side effects of older medications like SSRIs (such as Prozac and Zoloft) are well understood, there still isn’t a firm medical understanding of ketamine for psychiatric use, said Dr. Robert C. Meisner, the medical director of the Ketamine Service in the Psychiatric Neurotherapeutics Program at McLean Hospital, which is affiliated with Harvard Medical School.

    “One must balance clinical necessity with clinical uncertainty, as well as availability of other treatments,” he said. “We know more about [first-line treatments like SSRIs], so the risk-benefit is easier to access.”

    Meisner oversees ketamine treatments daily for his patients, but says he would like to see further research into the long-term effects of ketamine, what an optimal dose is, and what markers might indicate that a person will respond positively to ketamine.

    The early indications are reassuring, he said. Ketamine appears to be very safe and have a low risk for addiction or dependency. However, studies of recreational users have shown that people who use high levels of ketamine for long periods can have complications in the bladder, liver, biliary tract and suffer cognitive deficits. In order to be more comfortable with ketamine, scientists need to better understand at what point the drug goes from relatively harmless to potentially dangerous.

    “As the risks and benefits become better defined, especially over the long run, it is possible that there may come a point where ketamine isn’t a second- or third-line option, but is used earlier,” Meisner said. “As the research comes in, people will become more or less comfortable recommending ketamine sooner.”

    A Life-Saving Medication

    One area where people have been more apt to use ketamine is among patients who are highly suicidal. Ketamine is especially effective at reducing suicidal ideation, in as little as 40 minutes, making it a potentially powerful medication for people who are acutely suicidal in the emergency room.

    Even outside of emergency situations, ketamine can be lifesaving for people at risk for suicide. SSRIs and other antidepressant medications start working slowly, sometimes not reaching their peak effectiveness until six to eight weeks have passed. This period of time between starting the medication and the onset of full therapeutic effects is considered high-risk for suicide, because someone who is acutely depressed might still be suicidal, but now have enough energy to follow through on a plan that they previously couldn’t execute. Ketamine can be used as a bridging agent in these situations, giving quick, short-term relief of symptoms.

    “Relatively speaking, this is a fast way to rescue some percentage of people with depression from the horrific depths of it, and sustain them until the medication to which we’re bridging becomes therapeutic and can take over,” Meisner said.

    What the Future Holds

    Today, experts and the public hold diverging views about ketamine. Some, like Mandel and Ayo, see ketamine infusion therapy as a life-changing treatment. Much of the medical community, however, is waiting to see more research and to follow the results from these early uses of ketamine.

    “Some argue there is an ethical imperative to move quickly to ketamine,” Meisner said, but he also points out that it’s only been used to treat psychiatric illness in the last ten years, which is not long at all in terms of medicine.

    “Many doctors who work in neurotherapeutics see IV ketamine not as the end of the story, or the treatment that has at last arrived, but as a treatment modality that is evolving and will change as the mechanism is better understood and drugs that leverage that novel mechanism are developed,” he said. “I have high hopes for where the early work on ketamine leads us as we better understand its complex mechanisms.”

    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