J&J depression spray Spravato, carrying big expectations and restrictions, scores FDA nod

Johnson & Johnson has an FDA green light for its next big drug launch, and it's a drug sure to command attention as the rollout progresses: Spravato, a tweaked form of ketamine, which is used legally in anesthesia, but illegally as a street drug.

Also known as esketamine, Spravato won agency approval Tuesday, ushering in the first new treatment mechanism for major depressive disorder in decades. The nasal-spray drug is OK'd as an add-on to oral antidepressants in patients who have tried at least two antidepressants without success.

The drug won't come cheap. For the first month of therapy, when it's administered more frequently, Spravato's list price runs to $6,785 for the higher dose, before rebates and discounts. After that, depending on dose and frequency, the list price adds up to $3,450 max.

Spravato will launch under an FDA-mandated “controlled distribution model” because of safety risks. Still, the drug could bring new hope for many patients who haven’t seen much improvement on existing drugs. One patient in the drug’s clinical testing program, Robin P., said her “symptoms started to lift” on esketamine and that she could “see very clearly just how depressed" she had been.

“I’m now able to appreciate a wider range of emotions than when I was depressed,” she added. “My long-term goals have taken shape and actually seem attainable.” 

In two clinical trials—one short-term and one longer-term—Spravato and an oral antidepressant outperformed placebo and an oral antidepressant in reducing depression severity and fending off a relapse. But in two other short-term trials, the drug didn’t meet its efficacy endpoint. 

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Under the controlled distribution plan, patients won't be able to take the medication at home. They'll take it under the watchful eye of a healthcare provider charged with monitoring their response for at least two hours. The patient can't go home until the doctor agrees. Patients aren’t allowed to drive or operate heavy machinery until the next day.  

Patients start out with one month of treatment twice a week for a cost of $4,720 to $6,785—before discounts depending on dose, a J&J spokeswoman said. Afterwards, those who respond move receive treatment either weekly or every other week. Spravato's monthly cost after the first month ranges from $2,360 to $3,540.

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The drug carries a boxed warning for risk of sedation and difficulty with attention or thinking, risk of abuse and suicidal thoughts and behaviors. In clinical testing, side effects included disassociation, dizziness, anxiety, vomiting and feeling drunk. 

Even considering restrictions on the drug and its mixed clinical record, though, independent experts overwhelmingly endorsed the drug at an FDA panel convened last month. At the meeting, they noted the need for a fast-acting treatment for patients. By a 14-2 vote, the committee voted that Spravato's benefits outweighed its risks.  

Analysts have big expectations for the new drug and believe it can generate blockbuster peak sales. Previously, analysts with Jefferies predicted $3 billion in peak sales.

Spravato is J&J's next big drug launch as the pharma company pushes for "above-market" growth through 2021, and as its megablockbuster immunology drug Remicade comes under growing competitive pressure. The company has highlighted esketamine and erdafitinib for metastatic urothelial cancer among its key launches, and plans dozens of label expansions in the coming years to keep fueling sales growth.