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J&J’s Spravato breaks depression drought at FDA

The esketamine nasal spray is the first new-mechanism antidepressant to be licensed in decades

J&J

The FDA has approved Johnson & Johnson’s Spravato for treatment-resistant depression, making it the first new-mechanism antidepressant to be licensed in decades.

The green light for nasal spray formulation of esketamine – a derivative of the anaesthetic ketamine – is for use of the drug as an add-on to oral antidepressants in people with major depressive disorder (MDD) who haven’t seen any improvement in mood after trying two different drugs previously.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, acting director of the FDA’s Division of Psychiatry Products.

At the moment the only FDA-approved drug for treatment-resistant depression is Eli Lilly’s Symbyax combination of olanzapine and Prozac active ingredient fluoxetine, which was launched in 2009.

Nevertheless, the risk of side effects with Spravato, including sedation and dissociation and the potential for abuse and misuse, means it will only be made available via a restricted distribution system and must be delivered with two hours’ monitoring in a clinic. It will also carry a boxed warning about the risk of suicidal thoughts and behaviours in children and young adults.

The approval comes just a few weeks after an FDA advisory committee voted 14-2 in favour of licensing the drug, despite mixed results in clinical trials. One study in adults showed it was more effective than placebo in reducing symptoms of depression, but another in people aged over 65 only showed a trend towards improvement that didn’t reach statistical significance.

The FDA went against its usual procedures and allowed a third withdrawal ‘maintenance of effect’ study to be supportive of the marketing application, which is an indicator of the serious unmet need in treatment-resistant depression.

Treatment with intravenous ketamine has been available in the US through some private clinics but is priced at several hundred dollars per dose with six to get doses in a course, and as an off-label therapy it isn’t covered by health insurance.

Spravato should make the add-on therapy much more accessible and affordable, at least by limiting out-of-pocket expenses. J&J has said the wholesale acquisition cost of the drug will be between $590 and $885, depending on the dose, which will put a treatment course at between roughly $5,000 to $7,000.

Esketamine is a glutamate NMDA receptor modulator, and is of particular interest to clinicians because it starts to work much more quickly than current antidepressants. That speed of onset has won it a pair of breakthrough designations from the FDA, one in treatment-resistant depression and the other for MDD with an imminent risk of suicide.

J&J has suggested the drug is a potential $1bn product, although analysts are a bit more conservative, predicting annual revenues of around $600m in 2022.

Article by
Phil Taylor

6th March 2019

From: Regulatory

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