The Spravato nasal spray is produced by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Just yesterday, the United States Food and Drug Administration approved esketamine for use in the United States as a treatment for major depression. Spravato - a much less potent relative of the illicit club drug "Special K" - comes with other restrictions, the FDA said.More news: Former Yankee Alex Rodriguez Proposes To Pop Superstar, Actress Jennifer Lopez
"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. To lower the risk, the FDA said that the drug will only be available in certified clinics where medical professionals can monitor patients. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug's uses and risks. The new medication is indicated for patients who have cycled through multiple treatments without relief. The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray can not be taken home. Of that number, a study found that as many as one-quarter are treatment-resistant. After continuing Spravato as a treatment and were shown to be 51% less likely to relapse compared patients given a placebo and oral antidepressant.
But on Tuesday, the FDA added a potential fast-acting medicine to the list of happy pills with the approval of ketamine, an old and widely used surgery anesthetic that, according to Quartz, can help fight depression within hours (most meds take weeks to kick in).More news: Why a Tom Seaver statue is the Mets' likely next move
The most common side effects of Spravato include sedation, disassociation, dizziness, nausea, vertigo, lethargy, hypoesthesia or decreased sensitivity, anxiety, increased blood pressure, as well as vomiting.More news: Former Miss Teen Universe dies after suffering heart attack during vacation
The esketamine will be offered to the market with a brand name Spravato under the company of Johnson and Johnson.