Tuesday, 17 September, 2019

FDA approves controversial drug for depression

Ketamine-based drug approved for treating severe depression in the US FDA approves new Johnson & Johnson drug for depression
Anna Jefferson | 12 March, 2019, 17:56

It will be marketed under the brand name Spravato. 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. The new drug is closely chemically related to the club drug ketamine.

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. Spravato is a nasal spray from Johnson & Johnson that's a close cousin of ketamine, an anesthetic that's sometimes used recreationally and often known as "Special K". As part of UCLA's Depression Grand Challenge project, scientists are examining how ketamine might work in the treatment of depression and which patients might respond better to treatment.

Johnson & Johnson said the wholesale cost of each treatment with ketamine will range from $590 to $885, depending on the dose. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days.

The FDA's approval came in February, after its advisory panel voted in favour of the drug, arguing that esketamine's advantages dominated its disadvantages.

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.

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"I think we need to be cognizant of not positioning [Spravato] as a wonder drug or as a panacea, because it's not", said Steven Meisel, system director of medication safety at Fairview Health Services in Minneapolis, Minnesota, in an interview with BioPharma Dive.

Controversial: The Food and Drug Administration approved a controversial drug for depression Tuesday that could be the first of a long-awaited wave of new treatments, but has also raised concerns about abuse, The Wall Street Journal reports.

Clinical testing of Spravato yielded mixed results, with only one of three four-week clinical trials demonstrating a statistically significant benefit in favor of J&J's drug. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression.

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

The list price of a drug is not necessarily what patients actually pay. During the first month, patients will be treated twice a week.

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