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The Federal Food and Drug Administration (FDA) announced it had approved a new nasal spray for the treatment of long term depression. The drug is made by Johnson & Johnson and is marketed under the name Spravato.
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It will be prescribed by doctors for use in conjunction with an oral antidepressant for patients who have tried other forms of antidepressants that have not benefited from them. The drug's active ingredient is s ketamine a derivative of ketamine.
Long time coming
Due to the high potential risk of misuse of the drug, Spravato will only be available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). Spravato is the first major new depression treatment to be approved by the FDA since Prozac which entered medical use in 1986.
It is the first antidepressant drug to be approved that contains ketamine. Ketamine was approved for use as an anesthetic in the 1970s. Ketamine is used as a party drug in many parts of the world, and it is famous for its lack of ‘come down’ feeling.
Patients will administer a drug in office
Doctors have reportedly been prescribing ketamine ‘off label’ for years to patients who have not responded to more standard antidepressant medication.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system, and it must be administered in a certified medical office where the health care provider can monitor the patient."
So strict will be the conditions of use around Spravato that patients will only be able to administer the nasal spray inside their doctor's office and will not be able to take the medication home with them. Spravato was evaluated in separate short-term clinical trials and one longer trial.
One short-term trial that lasted four weeks determined that a combination of Spravato and an oral antidepressant demonstrated a “statistically significant effect” compared to a placebo. In some patients, this improvement was observed within a few days.
Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness. 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.
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.