FDA approves J&J's esketamine as faster-acting depression treatment

Ketamine-based drug approved for treating severe depression in the US

"We know that for someone who has failed two traditional antidepressants, if you try a third of the now approved medications, there's a [small] chance to achieve remission", said Dunn, who served on an FDA advisory panel which recommended approval of Spravato last month by a vote of 14-2.

The drug will cost $590 for a 56mg dose and $885 for an 84mg dose, and will only be available to people who have failed with at least two other antidepressant therapies.

Experts have said that while conventional antidepressants like the SSRIs or Fluoxetine or Paroxetine, Escitalopram etc. reduce depressive symptoms by increasing release of a chemical serotonin in the brain, Esketamine acts differently. Johnson & Johnson's new nasal spray contains the chemical mirror image of ketamine, which has previously been called a "party drug" because of its quasi-psychedelic effects. Spravato is a nasal spray from Johnson & Johnson that's a close cousin of ketamine, an anesthetic that's sometimes used recreationally and often known as "Special K". Companies like Allergan Plc Sage and Therapeutics Inc. are also testing depression drugs that can work quickly. The first month of treatment can range in price from $4,720 to $6,785, with subsequent monthly costs ranging from $2,360 to $3,540 before insurance discounts and rebates. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days.

Spravato, which is administered via a nasal spray, is the first FDA-approved antidepressant in over 30 years.

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A new drug has just been approved to help those battling depression who haven't had success with other treatments.

The drug will come with a label warning patients that it has the potential to be abused or misused. He said the approval legitimizes the approach he and other doctors have been taking. Due to the risk of potentially serious side effects like sedation and disassociation, Spravato will only be available commercially though a restricted distribution system. But the FDA's approval of esketamine could smooth their path. "It really has opened up a whole new way of thinking about depression", Gerard Sanacora, professor of psychiatry at Yale University School of Medicine and director of the Yale Depression Research Program, said of ketamine.

Patients will inhale the drug under supervision at these centers once or twice a week.

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