Esketamine, a Treatment for Depression, Receives FDA Approval

Grant Boone
March 8, 2019

The US Food and Drink Administration (FDA) yesterday licensed the nasal spray for use by those who have already tried at least two medications for depression, without success.

The FDA's approval came in February, after its advisory panel voted in favour of the drug, arguing that esketamine's advantages dominated its disadvantages.

Courtney Billington, the President of Johnson & Johnson's Janssen neuroscience division said that they have worked relentlessly to ensure that they have available resources with them to help patients with severe depression and the patients who were awaiting a quicker solution to get relief.

But a component of the drug, the anesthetic ketamine, a once-popular party drug known as Special K, has sparked concern about its long-term use.

In the United States, an estimated 16 million adults live with depression.

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Other side effects experienced by some patients treated with the spray in the clinical trials were dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk. In the longer study, patients whose conditions had stabilized and continued to take the nasal spray in conjunction with an oral antidepressant took a "statistically significant longer time" to relapse than patients who received a placebo nasal spray with their oral antidepressant. According to Johnson & Johnson, at least one-third of U.S. adults who have MDD also have TRD. "When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been", he said. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments".

So, if it's prescribed to be taken twice a week - a month's worth of the drug could cost between $4- to $7,000. According to the FDA, the nasal spray is administered by the patient him or herself while supervised by a medical professional.

The public health agency based the decision to approve esketamine after five Phase 3 trials proved the drug to be safe and effective.

There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. According to a report from Allied Market Research, the global antidepressant market totaled US$14.11 billion in 2017, and is expected to reach US$15.98 billion by 2023 and growing at a compound annual growth rate (CAGR) of 2.1 percent during the forecast period. Levesque says the effect will wear off after a few weeks depending on the patient.

Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.

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