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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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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.

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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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Ketamine For Severe Depression: ‘How Do You Not Offer This Drug To People?’

Gerard Sanacora, a professor of psychiatry at Yale University, has treated hundreds of severely depressed patients with low doses of ketamine, an anesthetic and popular club drug that isn’t approved for depression.

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A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders

Several studies now provide evidence of ketamine hydrochloride’s ability to produce rapid and robust antidepressant effects in patients with mood and anxiety disorders that were previously resistant to treatment. Despite the relatively small sample sizes, lack of longer-term data on efficacy, and limited data on safety provided by these studies, they have led to increased use of ketamine as an off-label treatment for mood and other psychiatric disorders.

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Use and Safety of Ketamine: In Plain Terms

Not surprisingly, a number of you have voiced your concern about our intention to conduct a study in which ketamine, a drug known to be abused recreationally and commonly used by veterinarians, will be trialed in children.

However, the current use, safety and benefits of ketamine are much greater than you might suspect.

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Depression: How effective are antidepressants?

Like psychological approaches, antidepressants are a key part of treating depression. They aim to relieve symptoms and prevent depression from coming back.

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