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How Ketamine Opens a New Era for Depression Treatment

Not for clubbers only.
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Researchers have discovered that ketamine, a drug of choice for club-goers for decades, can be used to fight severe cases of the blues. For more than three decades, patients seeking treatment for depression in the U.S. have been steered primarily to one family of pharmaceuticals. Doctors have been looking for more treatments, particularly for patients who haven’t had success with drugs or who have had suicidal thoughts. (The U.S. suicide rate increased 30% from 1999 to 2016.) Could a party drug be the key to solving the nation’s suicide crisis?

1. What’s ketamine?

It’s an anesthetic approved in 1970 as a safer alternative to phencyclidine, better known as PCP or angel dust. Ketamine became a common battlefield anesthetic during the Vietnam War, and by 1971 it was being used in much higher doses as a recreational drug. By the mid-1980s, ketamine was linked with dance culture in the U.S. and Europe, where it became a popular party drug that can produce euphoria and put users in a dreamlike state. At higher doses it can cause hallucinations and disassociation, a state in which users feel as if their mind and body aren’t connected, sometimes called the “K-hole.”

2. Why is it getting another look?

In March, Johnson & Johnson won approval for esketamine, a close cousin of ketamine, for patients with treatment-resistant depression, who make up one-third of the estimated 17.3 million Americans who have experienced depression. Administered via nasal spray, the drug, Spravato, is being billed as the first major therapeutic advance for depression since the introduction of Prozac in 1987. Spravato is undergoing additional studies, and the drugmaker hopes to win approval to use it for treatment of suicidal depression by 2020. (U.S. President Donald Trump expressed optimism that the drug can succeed in reducing suicides by military veterans.) Janssen, a subsidiary of Johnson & Johnson, filed marketing applications for esketamine in in the EU, UK, Canada, Switzerland, China, Japan, Australia, New Zealand and Colombia.

3. How is ketamine different from other antidepressants?

Most depression drugs, including Prozac, are part of a class known as selective serotonin reuptake inhibitors, or SSRIs. They work by blocking the re-absorption of the neurotransmitter serotonin, increasing the supply available in the brain. Ketamine works on the neurotransmitter glutamate, which is considered crucial in learning and memory formation. While SSRIs can take weeks or months to take effect, ketamine has been shown to begin working in as little as a few hours, making it the first rapid-acting depression drug. Another psychedelic drug that’s long been frowned-upon, so-called magic mushrooms, or psilocybin, also being studied as a potential treatment for depression.

4. When will it be available?

Some patients have already started taking Spravato for depression. Because of concerns about abuse, the drug is available to patients only under supervision at several hundred medical centers that Johnson & Johnson has certified.

The Reference Shelf

  • Bloomberg Businessweek on how esketamine can transform the treatment of suicidal patients.
  • President Donald Trump is impressed with Spravato’s potential.
  • Spravato has life changing potential, but may not be a surefire hit, Max Nisen argues in Bloomberg Opinion.
  • An academic paper detailing ketamine’s historyas a recreational drug.
  • Johnson & Johnson’s Spravato website, featuring a database of centers certified to give the treatment.



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Depression Therapy With Party-Drug Roots Faces FDA Panel Review

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Potential for abuse and strategies for containing any risks from an experimental depression treatment from Johnson & Johnson will be in focus at an Food and Drug Administration panel next week.

J&J’s nasal spray, esketamine, a close cousin of the party drug ketamine, will be considered by an FDA advisory panel on Feb. 12. While agency staff seemed satisfied that the likelihood of abuse is low, they raised questions about safety issues connected to a dreamlike sensation the medication can create in some users.

“Ketamine abuse is relatively uncommon in the general population,” agency staff said in a report ahead of next week’s meeting. Just 1.3 percent of people over age 12 abuse the drug, lower than abuse rates for other hallucinogens like ecstasy and LSD.

At the same time, reviewers worried that patients could get into accidents or otherwise be harmed if they leave a doctor’s office while still experiencing disassociation, a known side effect of ketamine — and a sought-after experience for casual users who have dubbed the spacey feeling the “K-hole.”

It takes roughly 90 minutes for disassociation symptoms from esketamine to resolve, according to the report. FDA staff also cited elevated blood pressure as a safety concern.

Esketamine is a key part of J&J’s pharmaceutical pipeline, as the company faces flagging sales this year weighed down by drug pricing scrutiny and looming generic competition. Its shares, which rose 2.3 percent this year through Thursday’s close, were were little changed in early trading on Friday.

In addition to weighing in on the drug’s safety and a proposed risk-evaluation and mitigation strategy, FDA staff will ask advisers to vote on whether esketamine effectively treated the depression of patients who weren’t helped by other therapies. They’ll also discuss whether additional studies are needed before or after the drug is potentially approved.

The staff report noted there were six deaths among patients taking the J&J drug, of which three were suicide in the esketamine depression program, but they didn’t see a clear link to the drug itself.

“Given the small number of cases, the severity of the patients’ underlying illness, and the lack of a consistent pattern among these cases, it is difficult to consider these deaths as drug related,” staff reviewers noted.

A decision on whether to allow the drug on the market is expected by March 4. Esketamine has the FDA’s breakthrough-therapy designation in treatment-resistant depression as well as for depressed people at risk of suicide. Results from a study in suicidal patients are expected this year. Allergan is also testing a fast-acting antidepressant, rapastinel, which is about a year behind esketamine in testing.