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!