- On Tuesday, a drug inspired by ketamine and made by Johnson & Johnson became the first new depression drug in 35 years.
- Regulators approved the drug, a nasal spray called Spravato, which is a brand name for esketamine.
- The approval comes on the heels of a favorable vote from experts last month who evaluated the drug’s safety and effectiveness.
- The list price of Spravato ranges from $590 to $885 per treatment session, depending on the dose a patient needs.
- Several biotechs have novel antidepressants in the pipeline, including Allergan and Sage Therapeutics. Sage’s drug is up for approval later this month.
A drug inspired by the anesthetic ketamine just became the first new kind of depression medication in 35 years.
Called Spravato, a brand name for esketamine, and developed by Johnson & Johnson, the drug is a nasal spray designed to treat severe forms of depression that don’t respond to other medications. Johnson & Johnson’s new nasal spray contains the chemical mirror image of ketamine, which has previously been called a "party drug" because of its quasi-psychedelic effects.
On Tuesday, regulators with the US Food and Drug Administration (FDA) approved Johnson & Johnson’s new drug, which is believed to have fewer negative side effects than ketamine, but said it would only be available to patients at a certified doctor’s office or clinic. Patients will take it along with another antidepressant pill.
The approval is a significant milestone. Depression is the world’s leading cause of poor health and disability, and as many as one in three patients don’t get relief from existing antidepressants. For several decades, psychiatrists and other mental-health researchers have expressed optimism about positive findings related to ketamine, esketamine’s chemical cousin. One group even called the drug "the most important discovery in half a century."
The list price of the new drug ranges from $590 to $885 per treatment session, depending on the dose a patient needs, Johnson & Johnson said. In the first month of treatment, patients undergo two sessions a week at a total price of roughly $5,000 to $7,000. In the second month, patients are treated weekly or once every two weeks, which helps lower the price to about $2,300 to $3,500 a month. The actual amount that patients end up paying will depend on how health insurers decide to cover the treatment.
The approval comes on the heels of a favorable vote last month from a panel of experts convened by the FDA who concluded that the drug was safe and effective. They also said they believed esketamine’s benefits outweighed its risks. Still, the experts said esketamine has some important negative side effects and limitations.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Tiffany Farchione, the FDA’s acting director in the division of psychiatry products, said in a statement.
And upon careful review, they felt Johnson & Johnson’s new drug met the criteria to become one of those treatments, Farchione added.
A nasal spray inspired by ketamine
Whether it’s Abilify or Zoloft, almost all antidepressants work by plugging up the places where our brain takes up serotonin, a chemical messenger that plays a key role in mood regulation.
Ketamine appears to engage a part of the brain that’s different from the area traditional antidepressants affect. This is part of the reason it has been called "the most important discovery in half a century" for mental illness.
The drug’s apparent rapid-fire effects may be especially useful for staunching suicidal thinking in people, experts say. Ketamine also has long been used to prevent pain, which suggests to clinicians that it’s relatively safe.
The same appears to apply to esketamine.
"I think there’s substantial evidence that this could be a game-changer," Steven Meisel, a system director of medication safety with Fairview Health Services and a member of last month’s panel, said after reviewing the data from Johnson & Johnson’s five clinical trials.
Most experts said last month that based on that data, esketamine appeared safe and well-tolerated, with some caveats. For example, they said the drug had some important negative side effects: More than a third of the trial patients reported feeling the "out of body" sensation known as dissociation, for example. About the same number of patients reported dizziness, sedation, and nausea.
Also in the clinical trials, the drug was given as a second-line treatment to patients with severe depression who failed to respond to at least two other antidepressants — not as a first choice for people with mild-to-moderate depression.
Reviewers also said that out of Johnson & Johnson’s five trials, one failed to meet the statistical threshold needed to show that it was better than a placebo.
To address esketamine’s side effects, the FDA will require that the drug be given in the presence of a clinician so patients can be monitored for a few hours.
"Because of [safety] concerns, the drug will only be available through a restricted distribution system," Farchione said. "And it must be administered in a certified medical office where the healthcare provider can monitor the patient."
While those steps may make the treatment less convenient for patients, they could also help keep the drug from being illicitly diverted and used for other purposes.
Given that few other drugs are available for severe depression, analysts see promise in esketamine. Some believe it has blockbuster potential, forecasting sales of roughly $2.4 billion in 2024 across the US and five major European markets.
Carter Gould, the executive director of biotech equity research at the financial firm UBS, said in a note circulated last month that he felt the drug was likely to be approved "especially in a disease paradigm where little options are available."
from SAI https://read.bi/2HensqF