FDA approves Johnson & Johnson's Fast-Acting Depression drug for quick relief from mental depression is undoubtedly a great success for the acute patients.
A variant of the party drug Ketamine has been licensed in the USA for treatment-resistant depression.
Dr. Steve Levine says having FDA-approved standards for dosing and administering the new drug should raise standards in the field and drive out some of the bad actors who are not qualified to treat depression.
Esketamine seems to help alleviate depression by acting on the NMDA/glutamate receptor, which is different from more recently popular antidepressants.
The Food and Drug Administration on Tuesday approved the nasal spray Spravato, which is based on the sedative ketamine, for treating the roughly 4 million American adults who suffer from severe depression but gain little to no benefit from available medicines and therapies. Spravato is meant to treat patients who have major depressive disorder (MDD) and have not responded "adequately" to two at least two different types of antidepressants.
Spravato is a form of ketamine, originally approved in the 1970s and used as an anesthetic.
The EMA is expected to take a decision on a similar application by drugs firm Janssen, part of Johnson & Johnson later this year or next year. Given in low doses through infusions, he says Ketamine is safe and effective.
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"The approval of esketamine is a groundbreaking advance in the treatment of depression, given its novel mechanism of action and time frame at which it produces clinically meaningful improvements", he told MedPage Today.
The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates.
Unlike ketamine, psilocybin and MDMA have no legal medical use. 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.
Many doctors who have become comfortable offering ketamine for depression probably won't switch to esketamine, said Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation and a clinical associate professor at Albert Einstein College of Medicine.
Patients will inhale the drug under supervision at these centers once or twice a week. At least 150 clinics around the USA provide treatment with various forms of the drug, which is available as a low-priced generic.
Some doctors plan to offer both ketamine and the new J&J drug.