FDA allows treatment of depression with club drug’s cousin

Desiree Burns
March 9, 2019

Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder.

The new antidepressant approved yesterday by the FDA achieves a number of firsts.

Spravato is a form of ketamine, originally approved in the 1970s and used as an anesthetic. Since the 1990s, ketamine has gained notoriety in the underground rave scene as "Special K", which can produce psychedelic effects.

The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is created to treat depression in patients who have not benefited from two or more antidepressants. Because ketamine can cause hallucinations and out-of-body experiences, the new drug must be administered in a clinical setting.

The approval is in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them. However, he cautioned that we do not know much about the long-term impacts of the drug, telling the Washington Post: "Doctors will have to be very judicious and feel their way along".

The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression.

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The FDA concludes the drug is also being tested in patients with depression who are at a high risk of committing suicide. Presently, this medicine is likely to cost between the ranges of $4,720 to $6,785 per month, however, Johnson & Johnson has assured that soon the prices of Spravato will decline to $2,360 to $3,540 per month.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

Still, there are few other options for patients who fail to respond to antidepressants. These clinics often administer the drug in an intravenous infusion that can cost more than $500 per treatment. Such therapies are generally not covered by insurance because they haven't been approved as safe and effective by FDA regulators.

But he hopes that doctors who are now using ketamine continue to do so.

"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", added Farchione. The AP is exclusively responsible for all content.

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