Ketamine is a disassociative anesthetic that has been studied for decades and has been proven helpful for depression and safe for those who have bipolar disorder. —-#ivketamine #resetketamine #therapy #depression #ptsd #anxiety #depressions #brain #science #dmtart #burningman #nytimes #research #medicine #medical #mentalhealthawareness #mentalhealth #psychonaut #psychedelic #news (1/18)

Nasal spray drug related to ketamine approved by FDA to treat depressionExperts believe that the OK for esketamine, a quick-acting nasal spray, is a pivotal moment in the history of mental health therapy.

FDA approves ketamine-derived nasal spray

MARCH 6, 201900:26March 5, 2019, 8:28 PM EST / Updated March 6, 2019, 11:21 AM ESTBy Shamard Charles, M.D.

The U.S. Food and Drug Administration on Tuesday approved esketamine, an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine, as a new treatment for severe depression.

The Johnson & Johnson nasal spray is a variation of the anesthetic ketamine — a pain reliever that was widely abused as a street drug, Special K, in the 1980s and 1990s. The newly approved drug by the FDA is the first major depression treatment to reach the U.S. market in decades. It is especially effective in patients who have not benefited from at least two different therapies, also known as treatment-resistant depression, the FDA said.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement Tuesday.

Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but the laborious process to administer the medication could be frustrating to patients. Experts believe that the FDA approval of a quick-acting, easy-to-use spray treatmentis a pivotal moment in the history of mental health therapy.

“This offers an extremely important, new treatment for people suffering with treatment-resistant depression,” Dr. Gerard Sanacora, professor of psychiatry at Yale University and director of the Yale Depression Research Program, told NBC News. “We know that if you don’t respond to the first two standard classes of antidepressants, the chances of you responding to a third or fourth reduces significantly, so this drug which has a completely different mechanism of action is particularly effective for those who have no standard treatment.”

Esketamine, which will be marketed under the trade name, Sparavato is an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine. It was approved as a new treatment for severe depression by the Food and Drug Administration Tuesday.Janssen

Drugmakers believe the spray can help 30 to 40 percent of patients who don’t respond to antidepressants.

The spray works more quickly than other known treatments, such as antidepressants which can take two weeks or more to take effect, showing benefits after only four hours.

“This is extremely important for people who need a drug with a quicker clinical benefit. Esketamine may shorten hospital stay or be used in people who have imminent thoughts or risks of hurting themselves,” Sanacora said.

Depression is very common. Around the world, 300 million people are affected and almost 800,000 commit suicide, according to the World Health Organization. In the United States, from 2013 to 2016, eight percent of American adults had depression in a given 2-week period, and about 80 percent of adults reported at least some difficulty with work, home or social activities because of their depression symptoms, according to the Centers for Disease Control and Prevention.

While not every person with depression thinks about suicide, the lifetime risk of attempting suicide for someone with depression is approximately 20 times that of the general population, even among those who receive adequate treatment.

Warning signs aren’t always obvious, and they may vary from person to person. Some people make their intentions clear, while others keep suicidal thoughts and feelings secret, underscoring the importance of quick and effective treatment.

“Depression is thought to be the leading cause of disability around the world. At the individual level, there is a close relationship between depression and suicide. In the U.S., there are over 40,000 people a year who die of suicide, and up to 17 percent of people are affected with depression at any given time. So, it’s not only very common but it can have very serious consequences, which is a dangerous combination,” Sanacora said.

In February, a federal advisory panel said the benefits of the nasal spray outweighed the risks. The panel noted that side effects, which include dizziness, nausea, increased blood pressure and an unpleasant feeling of dissociation, should be discussed with patients.

Sanacora, who was the lead author of a consensus statement that supported ketamine’s use in the treatment of mood disorders, says the drug is safe for use, but noted its potential for abuse, cautioning that the drug is still not recommended for at-home use.

“We’re a long way from this being an at-home or over-the-counter drug. Drug diversion is a real concern for this class of drug, so the plan is to give the drug to providers who would then administer the drug to patients on-site,” Sanacora said.

Although today is an exciting next step for the field of novel drug development, he said, experts believe more research on its long-term use and putting measures in place to limit access to teens will play a big role in the drug’s success.

“Studies looking at the long-term effects of esketamine have been conducted for up to a year, and there is an extension study that is currently ongoing. For esketamine, there was no evidence of cognitive deficits or trouble with the urinary bladder, as was seen in animal studies and those who frequently misused ketamine,” Sanacora said.

“Most antidepressant drugs are studied up to 8 weeks, so to have this one-year data is pretty unique,” he added.

Previously, the use of ketamine infusions to treat depression was not covered by insurance, and sessions ranged from $350 to $700. The wholesale price of the Johnson & Johnson drug is between $590 and $885 per session, the FDA said in a statement. Insurance coverage is anticipated.

Currently, Eli Lilly’s Symbyax is the only FDA-approved drug for treatment-resistant depression.

“Esketamine isn’t to be used in place of Prozac. This is meant to be used alongside standard treatments and not instead of standard treatments. We want people to use the medicine responsibly and rationally,” Sanacora said.

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Hello Again and Thanks for reading it is I David "IT40" Ellenberger with an update on the status of my lawsuit against Alphabet inc case # 4:20-CV-04877-SBA  and the website and life in general. By now if you regularly visit InternetTop40.com you may have read this section "author info" or Bio. So I am adding to it with more bio and more info. I originally liked the idea of voting on the internet 20-25 years ago when I first got online with WebTV (does anyone remember that?).

The technology at that time was not advanced enough to easily be able to vote online or watch videos or much else for that matter but I was hooked and look at what we can do now with videos, IOT, and everything else, but I digress. I started InternetTop40.com about 5 years ago and the user base has been going up steadily ever since. I wanted to be another Facebook, with music and voting and that is all coming together slowly but surely. BTW if you want to help or have any interest please feel free to email me anytime.

Now in my previous Author Info or bio page I made it clear or at least I thought I made it clear, I am personally suing Alphabet inc. in Federal Court for Fraud. I have evidence to prove they are not counting all the pageviews, among other things and defrauding myself and probably millions of other website owners and content creators out of Billions of dollars. So if I wasn't clear or you didn't know it's true I am suing Alphabet inc. in Federal Court for Fraud the case was recently moved from my state of Kentucky to N. California to make it easier for Alphabet inc. to steam roll me or so they think. Needless to say if you are interested and I hope you are you can look the case up online under my name "David Russell Ellenberger" or the case # which is 4:20-CV-04877-SBA.

Now, I want to make it clear to you and everyone that I am not suing Alphabet inc. aka Google for fraud just because I want a million dollars for nothing. I am suing Google for fraud because I think they are committing  a serious crime with worldwide and societal ramifications, it is a  very serious problem.  I am suing Google for fraud because to put it simply the analytics numbers don't add up at least not in my favor or yours, there is something very fishy going on with the Google analytics numbers. Of course Google has an excuse for every one of them but I have reasons and the actual numbers and they don't add up, more about the numbers later.

Companies like Google are making Billions of dollars a year in profits telling us data is the most valuable thing and misleading us and misdirecting the media and the world every chance they can.  Now data is valuable and they are making billions in profits seemingly like magic but there is no magic to it just corruption and lies. One thing Alphabet inc. aka Google is really making their money from and that is advertising dollars and they are putting all of this advertising on the websites other people have created.

Websites that I have created and  websites you have created and websites millions of others around the world have created websites or content. For example Just writing a text is creating content and that's where Google puts the billions in advertising they receive and keeping most of it for themselves. Yes content others have created and yet somehow they are keeping almost all of these billions for themselves and not distributing it equitably to the real workers the true content creators who actually deserve the advertising monies. Google has made it's billions on the backs of you and me. Think about that for a minute, how can they continue to justify this? They Can't, it has to change.

For example if I were to prevail in the current lawsuit just half of the monies or $20 billion put into a basic account and compounded at 5% annually we could realistically employ over 80,000 people at $24,000 a year, indefinitely.  Sounds unbelievable but its true and if we only employed 40,000 people we could pay them approx. $48,000 a year indefinitely. Its all true. Its simply a matter of having the money and the will to do it. Now is 40,000 people a lot well yes it would be a lot of employees but with more money simply put into a trust account we could employ more people

I David Russell Ellenberger through my website InternetTop40.com am suing Google to try to help right a wrong. A wrong committed by Google that has simply gotten out of hand. Most people may think they can't do anything about it. Nothing can stop Google, the politicians don't care they use all of Googles data to further their own campaigns and line their own pockets while the rest of us keep on creating the content for Google, nothing can be done, this however is not the case, we can do something.

The politicians and Alphabet inc. aka Google have done nothing to help society at large other than organize it so they can keep more money in secret and pay off all their buddies with their fraudulently obtained money. It's gotten so bad that the politicians and others in control won't even talk about it, they ignore it and hope it goes away, they won't even try to stop google because it is helping them too much and maybe they are scared of Google or who knows what they may be thinking. But it looks like fraud and it's coming to an end.

I'm telling you we can do something and I David Russell Ellenberger an average citizen Content Creator am saying to you, I'm not scared of Google because I have nothing left to loose.  I David Russell Ellenberger am telling you there is something you too can do, if nothing else, tell all your friends to come to InternetTop40.com aka IT40, believe these words and Create your Content.

Further I promise to you and all who read this if we do prevail in the lawsuit against Alphabet Inc. We will use half of any monies we may receive to pay "content creators" a living wage. I pledge to anyone who is reading this, we will use half of any monies we may receive to help those who really do want to work on the internet and create content and tell us what they think. We will use half of any money so you can Get Paid, we want you to get paid for the content you create and get paid everyday and Get Paid to Vote create data and to be able to do this work online and from your home or anywhere in the world you care to be. Because in the words of an ancient scholar Y-O-U are the business Y-O-U are creating all the data, Y-O-U are the content creators and Y-O-U are all that matters.

Now the main thing I want you to take away form this and to know, Alphabet inc. is and has been committing fraud against you, me and everyone who uses the internet. I don't think Google started out to defraud the world it has just degenerated into this endless morass of corruption and fraud and no one seems to care, Well I care and I know you care too.  Sadly Google has been doing this with impunity for years and it is only getting worse. Please don't let them fool you with their lies and obfuscation. Do some research create some content build a website and research the analytics numbers you will find I am right. Google owes you, me and everyone online thousands if not 10's of thousands of dollars for all the data and advertising dollars they have co-opted from you and the rest of the world. So join with me don't use any Google products or file your own lawsuit in federal court against Alphabet inc. I will be glad to help you any way I can and show you how to do it if need be. It will take a sincere effort on your part but it will definitely help your self esteem, society and the world.

Now that's about all I have to say on this subject for now.  I will tell you this if you want more information or you have questions or comments for me, my email is [email protected] Thank you for reading looking and listening and believing in InternetTop40.com Please tell all your friends about us and don't forget to vote Thumbs up or down and refresh your page when your done. One last Thing, I need all the help I can get I am only 1 person but together and with todays technology we can move mountains and reframe society and our world the way we want it to be. One final note let me tell you about a new website coming to the world called IVAMP.org.... Thank you ttyl

 

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