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FDA Approval Expected Monday of Ketamine-derived “Spravato”

 

 

 

TAKE HOME POINTS:

  • SpravatoTM, a form of ketamine, will be FDA approved on Monday for Treatment Resistant Depression and for Major Depression with suicidality.

  • FDA approval will result in insurance coverage for this form of ketamine, for this purpose, which will make it affordable for millions of suffering patients.

  • Although it is not as effective as an anti-depressant as the original formulation of ketamine, SpravatoTM should still help many people who have not had success with traditional anti-depressants, such as SSRIs.

  • SpravatoTM will only be given in a medical clinic, by healthcare providers. It will not be for at-home use.

  • Patients will receive SpravatoTM as a nasal spray. They will be required to stay for two hours in the medical clinic afterwards, so they can be monitored for elevated blood pressure, sedation, visual disturbances, and other potential side-effects. They will not be permitted to drive for the rest of the day.

  • SpravatoTM will be given twice a week for 4 weeks initially, then once weekly or every other week.

 

Ketamine was originally approved by the FDA as an anesthetic in 1970. The ketamine molecule comes in two mirror-image forms: a left-handed version, aka S-ketamine (the S is for sinistra, which is latin for left) and R-ketamine, the right-handed form. When the FDA approved ketamine in 1970, it was for racemic ketamine, which is simply a 50:50 mixture of the left and right-handed variations of the molecule. At Boulder Mind Care, we have been administering racemic ketamine to our patients since we opened our doors.

S-Ketamine

Interestingly, the two different forms of ketamine, when isolated and compared to each other, have quite different characteristics. R-ketamine is a more potent anti-depressant. S-ketamine is better at alleviating certain types of chronic pain.

Racemic ketamine became generic several decades ago. However, when ketamine’s paradigm-busting effectiveness in depression and anxiety disorders became apparent, Big Pharma giant Johnson & Johnson’s subsidiary Janssen Pharmaceuticals decided to cash in. Their strategy: applying for FDA approval of the S-ketamine molecule for Treatment Resistant Depression. Even though drug companies cannot profit from generic ketamine, Janssen exploited a loophole in the New Drug Application patent laws in the United States, by using only the left-handed version of ketamine. Janssen is projected to bring in annual revenue from $490 million to as much as a billion dollars from SpravatoTM.

In 2016 the FDA fast-tracked the approval process for Spravato, recognizing the unmet need of millions still suffering from treatment resistant depression, and that FDA approval will also mean coverage by insurance companies. However, only two of J&J’s five pivotal clinical trials in support of the marketing application were considered successful. Despite this, on February 13th the FDA advisory committee voted 14-2 in favor of Spravato coming to market. The FDA’s willingness to accept a lower standard of efficacy evidence stems from the dire need for insurance coverage and additional treatment options for treatment-resistant depression, which is associated with a higher risk of self-harm and suicide.

Racemic ketamine has been studied much more extensively over the past 19 years, and has been demonstrated to be a superior anti-depressant than esketamine. In addition, intravenous infusion is the route of administration in the vast majority of the research studies to date, and remains the gold standard for precision dosing. Nonetheless, we are excited by the arrival of Spravato. J&J’s marketing campaign will raise public awareness of both types of ketamine in the treatment of mood disorders. Suicide is the tenth largest cause of death in the US, and the only one that is increasing every year. We need all the help we can get!

 

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End The Stigma!

Lady Gaga and Bradley Cooper did a masterful remake of “A Star is Born”, now in theaters. We highly recommend it! The issues of mental health and drug addiction are more timely than ever. Also, see Lady Gaga’s op-ed at lady-gaga-op-ed-on-suicide-and-mental-health.

END THE STIGMA!

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The Resurgence of Psychedelics in Medicine

There has been a flurry of articles in the media recently touting the successful use of psychedelics in medicine. Tim Ferriss, the New-York Times bestselling author, blogger, and angel investor, whose podcast has over 200 million downloads, recently interviewed Michael Pollan about his new book on the emerging science of psychedelics in what Ferriss dubbed “the most important podcast episode  I’ve put out in the last two years”.

Ferriss is so passionate about this topic that he has publicly committed to donating a million dollars of his own money to support the scientific study of psychedelic compounds.

Examples of the emerging successful use of these compounds in medicine include ketamine for depression, PTSD, anxiety, and chronic pain, MDMA for psychotherapy and PTSD, psilocybin for cluster headaches and terminal cancer patients, and Ibogaine for drug addiction.

Here in the front range of Northern Colorado, local journalist Reilly Capps recently published an interesting article on the topic as well.

Indeed, ketamine infusions are not voodoo medicine, not fringe science, rather they truly are a paradigm-shifting revolution.

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Ketamine Infusions Provide Effective Relief for Severe Chronic Headache

Medical research is revealing more and more applications for ketamine, the old drug being used in new ways. Just as with Treatment Resistant Depression, where ketamine provides relief in 80% of patients, it is also often successful at relieving intractable headache pain. Indeed, the term “Treatment-Resistant Headache” could be used for the millions of women and men suffering from chronic, severe migraine headaches. Many of these patients spend years trying to find relief using a variety of medications and adjunctive therapies, often in vain.

Ketamine provides significant pain relief among patients with refractory headaches, as per study findings presented  by Eric Schwenk MD, at the annual meeting of The American Society of Anesthesiologists, held October 21-25, 2017 in Boston, Massachusetts.

Dr. Schwenk, associate professor and director of orthopedic anesthesia at Jefferson University Hospitals in Philadelphia, stated “We found that patients with these types of headaches who received infusions of ketamine experienced improved pain control during their infusions.” “The findings of this retrospective study are exciting as they point to a {breakthrough} for patients who have failed essentially all other options,” concluded Dr Schwenk.“

At Boulder Mind Care, we are achieving success using Ketamine infusions to provide relief for severe migraines, and other intractable types of head and facial pain. We are here to help you “Love your Life”, to no longer spend day after day, year after year, laying in bed at home in misery, unable to work, play, be a good parent or spouse, and generally enjoy life. Contact us today.

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New Insight Into How Ketamine Works in Depression

Ketamine exerts an initial antidepressant effect by blocking the N-methyl-D-aspartate receptor (NMDAR), and the ketamine metabolite hydroxynorketamine (HNK) may extend the duration of the effect. The findings could lead to the development of safer alternatives.

more… (registration required)

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Techies Are Using Ketamine to Fight Their Depression

Sean Spencer is a pretty successful entrepreneur in LA’s startup community but he also struggles with depression, so he uses ketamine to help with his lows.

 

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Inside the Los Angeles Clinic That Uses Ketamine to Treat Depression

Depression is all too common, especially among people in the tech sector. That’s why denizens of Silicon Beach have been flocking to a local clinic that offers a radical alternative when standard treatments fall short.

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How Untreated Depression Contributes to the Opioid Epidemic

It can sometimes seem strange how so much of the country got hooked on opioids within just a few years. Deaths from prescription drugs like oxycodone, hydrocodone, and methadone have more than quadrupled since 1999, according to the CDC. But pain doesn’t seem to be the only culprit: About one-third of Americans have chronic pain, but not all of them take prescription painkillers for it. Of those who do take prescription opioids, not all become addicted.

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FDA Data Support Ketamine as Depression Therapy

An analysis of data from the FDA Adverse Events Reporting System (FAERS) supported previous findings that ketamine could be an effective treatment for depression, researchers found.

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Population scale data reveals the antidepressant effects of ketamine and other therapeutics approved for non-psychiatric indications

Current therapeutic approaches to depression fail for millions of patients due to lag in clinical response and non-adherence. Here we provide new support for the antidepressant effect of an anesthetic drug, ketamine, by Inverse-Frequency Analysis of eight million reports from the FDA Adverse Effect Reporting System. The results of the examination of population scale data revealed that patients who received ketamine had significantly lower frequency of reports of depression than patients who took any other combination of drugs for pain. The analysis also revealed that patients who took ketamine had significantly lower frequency of reports of pain and opioid induced side effects, implying ketamine’s potential to act as a beneficial adjunct agent in pain management pharmacotherapy. Further, the Inverse-Frequency Analysis methodology provides robust statistical support for the antidepressant action of other currently approved therapeutics including diclofenac and minocycline.

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