New Depression Treatment-Ketamine-related nasal spray approved by FDA

Discussion in 'Up to the Minute' started by SeekingJana, Mar 6, 2019.

  1. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression

    There is no " Panacea for the pain" of long-standing depression which is severe, often with suicidal thoughts and attempts.
    However, the newly approved nasal spray, brand name Spravato, ( J&J) is the most revolutionary medication treatment in my lifetime, and there are great hopes that it will help many people with drug- resistant and psychotherapy resistant depression.

    So, how does this work? Ketamine and J&J's version of the closely related Esketamine work differently than any other anti-depressant ever approved for use. The drug targets a chemical called glutamate that is thought to restore brain connections that help relieve depression.

    Only certain psychiatrists with special certification in the administration and monitoring will be allowed to prescribe the nasal spray, and the drug can only be used in the presence and supervision of the physician in the office or in-patient setting, whichever is appropriate for the individual client.

    We have needed something which " breaks the chain" of depressive thoughts, and electroconvulsive therapy has been all there was which acts to do so. Some people are not candidates for ECT due to age, the anesthesia which must be given, and the side effects of memory loss, which may be severe in some people, even with the newer lower settings. Also, many people refuse to participate because of the old horror stories, and I understand why.

    IF this drug, Esketamine, or a similar form of Ketamine is used correctly and IF the psychiatrists who are trained to both oversee the patient administration of the nasal spray ( or IV infusion for Ketamine) and stay with them as it works, I believe this could be a " magic bullet" for many people to end the downward spiraling of deadly suicidal thoughts, plans and attempts. It's also being given to those who have had multiple hospitalizations for treatment of major depression which doesn't respond to the current anti-depreesants available.

    Some doctors have been prescribing Ketamine off label for severe, resistant depression for a few years. The problems, when they occurred, were related to monitoring and the fact that dosages administered were not standardized for safety. By safety, I mean that Ketamine can have transient, short-lasting disorientation and sometimes, a short " out of body" feeling. We see this same thing with most other drugs which are routinely used as preoperative sedative medications, but in higher doses. It is NOT believed that the very low dose nasal spray will induce any of the disorientation or depersonalization effects when patients are screened for suitability of treatment.

    How Spravato will be given: Each therapeutic dose of nasal spry are usually given every 2 weeks in a psychiatrist's office who has the certification obtained through training to monitor and support clients during the drug's psychoactive period.
    It is a very short- acting drug, but because there is a potential for abuse and short unpleasant side effects in some people, I don't see how it could be self- administered.

    Ketamine is mostly used IV as part of the sedation meds. given in the pre-op holding area by the anesthesiologist prior to surgery under general anesthesia, and is generally well- tolerated. It can produce some mild hallucinogenic effects, but usually not at the recommended therapeutic dose.
    Large syringes of Ketamine were developed and used originally as horse sedatives in vet practice. In the 1990's, the drug was diverted/ misused for a time as " Special K" at rave parties, but isn't thought to be widely used illegally at present.

    The only downsides I've recognized in professional literature about the clinical trials are the cost of the nasal spray, around $500 per nasal spray bottle, and the strict supervision needed to prevent a slightly groggy or disorientated client from leaving the office setting too early post- treatment.

    From what I've read, this is a very fast acting medication in that relief from depression is quick. It doesn't take months like the current SSRIs and SNRIs take ( if they work at all). The difference in the clinical trials are so promising and the results in those receiving the drug and not a placebo are extremely positive. The amount needed in 2 week or so intervals will vary from person to person, but at present, severe chronic depression is being relieved in a matter of weeks in the study clients. Whether or not it will return is not known, but it's widely thought that once the circuit breaker of depression and suicidal thoughts is broken, it stays broken and brain chemical functioning is normal. Likely, mental health visits to monitor mood levels will be a part of the long-term treatment plan.

    Probably most of us have lost someone we loved to suicidal depression. I lost my best friend, a psychiatrist I was friends with and worked with, when we were both 31 years old. I believe he'd definitely have tried Spravato, had it been available to him with a psychiatrist certified in the use and monitoring. I'd have strongly encouraged him to try it for the recommended time in the absence of an adverse reaction.

    In the clinical setting, I've seen the pain of deep depression and also the devastation of suicide- more times than I want to remember.
    There's simply no way to put a price on the value of restoring a normal mood in the many cases of people who are suicidal.
    Great hope is riding on this new drug therapy for those with chronic, severe depression.

    If anyone reading here or someone you know has deep depression with suicidal thoughts or attempts, I hope with all my heart that either this first formulation of Esketamine, the Spravato low- dose nasal spray, or subsequent forms will help you and a qualified treatment team save your life by eradicating the depression, and restoring a normal life.
     


  2. wendybtn

    wendybtn Well-Known Member

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    I hope it works as advertised. Now the problem will be access to the few doctors who are qualified to give it.
     
  3. Sanz

    Sanz Well-Known Member

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    I have used Ketamine Nasal spray for anxiety about 8 years ago. It was prescribed to me by my Neurologist. The prescription was picked up at a Veterinary office that kept it in a safe. It did not work for me nor did it give me any type of side effects. The drug is extremely abused in the drug culture. I don’t see a problem in getting it if a person meets the criteria. I am in Washington State.
     
  4. wendybtn

    wendybtn Well-Known Member

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    This version is only given by an especially trained psychiatrist to the patient in the doctor's office.
     
  5. sloane7777

    sloane7777 Well-Known Member

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    Which will be pretty much unattainable for most of us who don't respond to other meds ...sigh
     
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  6. MOTORUNNER

    MOTORUNNER My echo, My shadow, and Me

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    Interesting.... I've been on and off so many different medications the past year. Zoloft, Lexapro, paxil, buspar, klonopin, effexor.. now I'm on prozac. It's funny for me to read this because some of my younger friends love doing Ketamine as a party drug. I'm interested to see where this goes though... maybe Ill ask next time I'm in
     
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  7. LadyL

    LadyL Well-Known Member

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    hmm
    I don't have much faith in its success rate.
     
  8. Mauig’ma

    Mauig’ma Well-Known Member

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    I met with my Subutex Dr today. He said it’ll be closer to 6 months before it’s available. The doctors need to be trained and certified which takes time. Once that’s in place only then will patients be able to start scheduling appointments. Shucks I was hoping to get a dose today!
     
  9. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    We saw a similar special training and prescription restriction in Psych. medication with the drug Suboxone, which is used to treat opioid addiction in the withdrawal phase of detox. and recovery.
    10 years ago, when it was new on the market, only board certified psychiatrists who had taken CE courses and passed exams related to the properties of the drug and the risks, the starting and decreasing dosages, etc. were allowed to prescribe it.

    The reasons for the extra training and proficiency exam in prescribing are related to the fact that one of the 2 medications in Suboxone can precipitate acute withdrawal in some patients, and Suboxone ( and the other meds with same ingredients but with different brand names) can also be addictive by itself. Not much benefit in getting someone clean of Vicodin to have them dependent on Suboxone due to improper monitoring and dosages given. I believe the doctors had not only a DEA and controlled substance ID number but an ID number specific to the prescriptions for Suboxone, which was a special DEA number with an X added by the federal DEA after completion and passing the course needed to use it in clinical practice for the purpose of opioid withdrawal. Also, at first, each psychiatrist who was authorized to prescribe the medication could ONLY prescribe it for a few patients in active detox at a time. The current number of patients receiving prescriptions is 30 per DEA- certified M.D. each, in total. ( Some people do not choose to continue taking it, some cannot tolerate it, some had rather have their Oxycontin back, new patients come for the treatment, so the numbers change, but the total cannot exceed 30 patients per doctor). When it was first released, I believe the total number was 15 monitored patients on Suboxone per doctor.

    Here's a fairly balanced article for laypersons about Suboxone.
    Let's Talk About the Dark Side of Suboxone - DrugAbuse.com

    It was really the first widespread radically new drug in the psychiatric classification of medications in many years.
    I did see people in acute withdrawal, thus the Suboxone was either being started at too low a dose, was started after the patient had already passed their personal tolerance level in withdrawal, or it was tapered off too quickly.
    However, prior to its manufacture and slow introduction into mainstream treatment of opioid detoxification and sobriety, there had been NO drugs available to safely and slowly detox. those with opioid dependence/ addiction, with the exception of Methadone for heroin addiction.. and Methadone works nothing at all like Suboxone.

    The reason I bring up Suboxone is because I've seen some great results, usually from those who are willing to tolerate some side effects of withdrawal and participate actively in their inpatient therapy. I've also seen horrible results from different causes as discussed- usually a starting dose that is too low, or possibly poly substance addiction with the patient only giving a partially correct narrative of their drug use.

    Any new psychoactive medication has the potential to cure or kill, in the most basic terms which can be stated. Ketamine and its derivatives are used safely in O.R. as an adjunct to general anesthesia regularly. We know it's safe for the induction of the unconscious state.

    In small doses, it is short- acting and clinical trials have shown that for some people with resistant depression, it is safe and effective for a change in the neural pathways due to a changed glutamate uptake in neuroreceptor brain cells.
    At present, the emphasis of use is in those who can safely take the medication and who have a high risk of suicide which is long-standing and resistant to other medications and treatments.

    I don't expect the restrictions on any form of Ketamine administration to be as severe as that of Suboxone because we have a long history of Ketamine safety, side effects, adverse reactions, contraindications and precautions in the practice of Anesthesiology.

    Other safety features are the markedly decreased doses for treatment resistant depression compared to the dosages given for anesthesia, and the short duration of action of the medication itself. ( The short duration of action is why we didn't see a lot of drug deaths from the illegal street distribution in the 90's when it was called " Special K" on the streets.)

    Some people with mental health problems and long-standing depression or mistrust of psychiatric treatment in general are going to view any treatment in a suspicious and negative way, because they are suspicious and negative people. That's their right and also their responsibility to bear.

    For the mental health community as a whole, the FDA approval and release for monitored use is a great hope for obliterating the most severe depression and likely will have usage extended to the treatment of both new and long=standing PTSD resistant to other therapy modalities as well, but probably in higher dosage.
     
    Last edited: Mar 6, 2019
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  10. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    No, actually, the results of the U.S. clinical trials in all phases have been extremely positive. There is great motivation for psychiatrists, especially, to take the educational course, usually about 8 hours, or it was for Suboxone which I discuss in another post on this thread, pass the course, and receive a special DEA designation to prescribe the medication in an outpatient setting ( doctor's office with the doctor in attendance at all times).

    It is specifically targeted for those who have treatment resistant depression of long-standing duration with suicidal thoughts. There are a few other criteria for patient selection but they are easy to meet in a person who's been depressed for years and no current anti-depressant has proven effective.
     
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  11. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    The drug is available and there are doctors who conducted the clinical trials so there are SOME doctors who are already skilled in the administration and monitoring. Likely, they will be instrumental in the educational process for other doctors.

    It is prudent for the DEA to require physicians to take the standardized educational course, be certified and likely, have a limited number of clients receiving the medication at one time. ( Like Subutex and Suboxone- exact same premise, different drug, this one with a long history of use in the O.R.).
     
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  12. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    Deleted by Seeking Jana.
     
    Last edited: Mar 6, 2019
  13. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    How did a veterinary office happen to have Ketamine in a preparation for nasal inhalation? o_O
    Are you saying that in WA, animals receive nasal sprays of drugs? :eek:
     
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  14. sloane7777

    sloane7777 Well-Known Member

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  15. The 13th

    The 13th Well-Known Member

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    Thanks so much for all this information. If this can provide relief for any number of people, specifically those who have treatment-resistant chronic depression, I believe that it will save lives. The unrelenting nature of some types of depression is the hardest part of it for some people.
     
  16. MOTORUNNER

    MOTORUNNER My echo, My shadow, and Me

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    Yes... a sad topic to come back to as a friend of mine committed suicide this weekend. We were not extremely close but she was from my hometown and was a good friend to many of my friends that still lived there. She was on several medications and saw several doctors but in the end she just couldn't handle it. I hope this medicine can help someone, somehow out there. I doubt I would qualify or even be able to afford it, but I know how tough it is when medication doesn't seem to help and your doctor keeps bouncing you from one to the other... some of them making you sick from their side effects to becoming sick with withdrawl.
     
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  17. wendybtn

    wendybtn Well-Known Member

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    If you do it too much you end up with a condition called anhedonia. Not pleasant at all.
     
  18. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    For those who do not know, the term " Anhedonia" means " lack of pleasure or enjoyment in any activities designed for pleasure, either sexual or generally recreational".
    By definition, it must include a total lack of enjoyable response to any and all activities which normally stimulate the pleasure centers in the brain.
     
  19. Sanz

    Sanz Well-Known Member

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    In my own medical treatment in 2006 when my Neurologist prescribed Ketamine Nasal Spray it was only available in Seattle Washington through a Veternary Hospital, they did fill the prescription in a nasal spray. I don’t know the dynamics in where this drug was kept.

    Here is a very informative article on different uses of Ketamine. Maybe this will answer your question.

    Ketamine: an Animal Tranquilizer and a Club Drug?
    Ketamine: an Animal Tranquilizer and a Club Drug?
     
    Last edited: Mar 13, 2019
  20. SeekingJana

    SeekingJana May I be the person my dogs think I am! :)

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    Thanks, but I was a registered nurse for 30 years prior to becoming a professional therapist, and Ketamine is a drug I am familiar with, in vet. practice, as an old and not so pleasant street party drug, and as an I.V. medication in the use of anesthesia most of all.

    My question had to do with the pharmacodynamics. The basic facts of drug administration differ from route to route and there is usually NO possible cross-over from route to route. There is one notable exception which is never in the non-professional domain for administration- In the event of circulatory collapse, emergency medications which would be given IV can be given sublingually until or unless a central or peripheral arterial or venous access can be established:

    When comparing and contrasting the manufacture and admixture of medication, the route of administration determines how medications are prepared for different routes in different ways.

    1) The mode of action of a medication is determined at the time of manufacture. An IV drug is especially purified in special laminar hood air flow rooms with no bacteria, and with a lack of particulate matter which could cause an embolus in the circulatory system, most notably fatal in the lungs, when injected with correct technique.
    An example of this sterile technique and extreme care with filtration can be seen in the deaths arising from compound pharmacies which made steroids for injection, contained bacteria, mold spores and foreign matter ( particulate matter).
    A Google search will take any interested party to the outbreak of human deaths a few years ago which were totally preventable.

    Similarly, nasal spray is manufactured AS a nasal spray at the pharmaceutical company laboratory to be metered dose efficient and also to aerosolize in an even, fine mist spray. There will be inert carriers, usually saline or another well-tolerated and commonly used carrier mixed into the nasal spray bottles at the time of manufacture. The carrier liquid will be pH compatible with human mucosa, and the bottle of medication will be sterile until the safety seal from the manufacturer is broken. Once used and contacted to the nasal mucosa and secretions, the spray is no longer sterile. Nurses label these types of medications as to the date opened and time opened and there will be a window of stable and safe usability.

    Thus, the IV formulation of a drug does not equal that which is inhaled into the nasal mucosa.

    I would not expect a Vet practice to have any need whatsoever for nasal spray in their practice, and I think we all know this is true for the obvious limitations of animal cooperation with various methods of medication administration, which does not extend to nasal sprays of any type.

    Therefore, I think the vet practice either misused their scope of practice as licensed, or there's something.. not.. quite... understandable about the chain of events as related about nasal spray being obtained for a human from a vet practice..

    While some of us have obtained human medications for our pets when there was no good vet. substitute and the vet wrote the prescription, it never goes the other way. A human with their faculties of reasoning does NOT consume a medication meant to be used for animals. The method of production is extremely different and the safety standard is quite lower.

    This is my last post on this entire subject.

    Those who are candidates for the human nasal spray as prescribed by a qualified trained psychiatrist with specialized training in the use and observation of each patient will likely receive the drug through government and other insurer and drug company assistance for a few years into production.

    Since the therapy is said to be short term to prevent either physical or psychological dependence on the nasal spray, and also because this is designed to be a short- term therapy from the outcome of research data in phase II and III clinical trials, the resources should be sufficient, regardless of any other extrinsic factors.

    I will not be available to discuss this topic in the future, but I hope those who may benefit for another tool to fight long-standing treatment resistant depression with suicidal thoughts who meet the criteria to receive the therapy will have access to it. Also, that the success rates will be close to what we have seen in clinical trials.

    Best to all regarding this new treatment. Mental health is not one size fits all, but sometimes, we get extremely lucky and a person who's struggled for a very long time will find a treatment and/ or a therapist who finally breaks through the walls and helps them find wellness again.

    Respectfully, IMO.
     
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