Saturday, 23 March, 2019

FDA allows treatment of depression with club drug's cousin

Ketamine-based drug approved for treating severe depression in the US FDA approves new Johnson & Johnson drug for depression
Johnnie Parks | 12 March, 2019, 17:55

Spravato was evaluated in four clinical studies, during which some users took the nasal spray and an oral antidepressant they hadn't tried before. That means patients who have not responded to "at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode", according to the FDA. Esketamine and ketamine work by targeting glutamate, unlike now used antidepressants that target serotonin, and doctors were already using ketamine off-label to treat depression, according to the AP.

The FDA says the most common side effects of the drug observed in the trials included disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

WASHINGTON | A mind-altering medication related to the club drug Special K won USA approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates.

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.

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The nasal spray must be taken by patients under the supervision of a healthcare provider in a certified doctor's office or clinic and the spray can not be taken home. In a recent interview with Scientific American, Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, said the drug had undergone only one government-supervised trial and needed a second.

Spravato is a form of ketamine, originally approved in the 1970s and used as an anesthetic.

The nasal spray, from Johnson & Johnson, has been approved for use by the US Food and Drug Administration (FDA) and is the first treatment to tackle depression in a new way for decades.

Spravato will be sold through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS), due to the FDA's concerns for the potential of abuse and misuse of the drug. Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said. By the second month, a patient will receive treatment once a week or every two weeks, which will reduce the cost to between US$2,3000 and US$3,500 per month.

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

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