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FDA Approved Novel Ketamine Treatment For Depression

1 year, 6 months ago

3998  0
Posted on Mar 05, 2019, 9 p.m.

The FDA has just approved a nasal spray called esketamine as a new tool to help fight depression among those who do not respond to other treatments; this is the first in decades to work in a completely new way in the brain.

The spray has been eagerly anticipated as it works within hours rather than weeks or months, and may offer a lifeline to some 5 million people within the USA alone suffering with major depressive disorder who have had no benefit from other current treatments; this accounts for around 1 in 3 patients with depression.

Although it is a significant advance, there are still those that caution much isn’t known about it’s long term use. Labeling for its box must carry a black warning issued from the FDA cautioning people who take the drug that they may experience sedation, disassociation, increased blood pressure, and problems with attention, thinking, and judgement, along with potential for abuse and suicidal thoughts. Those who will be taking esketamine have to be monitored for at least two hours after taking a dose to help guard against some of these effects.

The drug is derived from ketamine which gives it the complex legacy. Ketamine was approved many years ago as an anesthetic, and was once popular as the party drug Special K. Esketamine must be administered under medical supervision and can only be used in a certified clinic or doctor’s office according to FDA approval conditions, and it is to be taken along with an oral antidepressant.

To some searching for a treatment for depression results from ketamine treatment can be profound. Mount Sinai did extensive research in 2000 and published their results showing intravenous ketamine therapy to rapidly relieve depression within a few hours.

Esketamine makers Johnson & Johnson received approval to sell the drug which will appear under the brand name of Spravato. They opted for a nasal spray after concluding IV administration was impractical, and pill forms were not capable of delivering enough to the brain.

When it was used as the party drug Special K which replaced MDNA/Molly it had powerful euphoric effects such as happiness, sleepiness, hallucinations, tunnel vision, and dissociative effects that could make some feel untethered from their surroundings.

Ketamine has been used for decades off label to treat depression. There may be some risks to the drug but the benefits exceed those, along with safety measures that will be put in place, and the fact it can only be administered under supervision at a certified health clinic. Patients can receive treatments twice a week for a month, then once a week for a month, then finally every other week along with an oral antidepressant. It will be up to the patient and doctor if the patient will remain on the drug for more than 6 months or a year.

Antidepressants typically target the neurotransmitters dopamine, serotonin, or norepinephrine; however esketamine affects receptors for the brain chemical glutamate. Esketamine is the s-enantiomer of ketamine, which is a mixture of two enantiomers. This is the first FDA approval of esketamine for any use to Janssen Pharmaceuticals Inc., (ketamine was approved in the 1970s). Esketamine was granted application through FDA Fast Track and Breakthrough Therapy.

Spravato was evaluated in 3 short term randomized controlled clinical trials according to the FDA release. The most common side effects experienced were disassociation, nausea, vertigo, dizziness, sedation, anxiety, lethargy, vomiting, feeling drunk, decreased sensitivity, and increased blood pressure. It may impair attention, thinking, judgement, reaction speed, and motor skills. It is not recommended to drive or operate heavy machinery, or for those who are pregnant or planning to conceive, those who are breastfeeding, and those with unstable hypertension or pre-existing aneurysmal vascular disorders.

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