FDA approves nasal spray for treatment-resistant depression

Pearl Mccarthy
March 9, 2019

The approval of J&J's modern-day anti-depressant nasal spray marks the first advanced treatment innovated for fighting depression in decades.

Spravato, which is administered via a nasal spray, is the first FDA-approved antidepressant in over 30 years.

But esketamine presents some challenges because of its similarities to ketamine. It is often abused as a party drug with the nickname "Special K", but it has also been shown in studies to have a fast-acting impact on depression symptoms. The FDA said users should be monitored by a health care provider for at least two hours after receiving Spravato.

Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers. "This has implications for treatment-resistant patients who have not responded to standard antidepressants, as esketamine potentially offers a better chance at achieving remission than traditional medications".

A decades-old drug, ketamine is already used off-label to treat depression by some doctors.

Tiffany was diagnosed with depression as a child and tried dozens of antidepressants that didn't work for her.

Some 16 million people in the US have major depression, and one-third of them have not responded well to available treatments and may therefore be considered to have treatment-resistant depression. The second trial considered in support of the drug was a withdrawal study, and FDA said its division of psychiatry products had not previously considered such a study as one of the primary pieces of evidence for an approval, but added "it is not unreasonable to do so" in its report.

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"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

Now available anti-depressants such as Eli Lilly and Co's Prozac work on neurotransmitters like serotonin and norepinephrine, but most drugs take at least four weeks to show effect and fail to produce an adequate response in about 30 percent to 40 percent of patients with major depressive disorder (MDD).

The drug will be administered at clinics under supervision.

The list price of a drug is not necessarily what patients actually pay. Such therapies are generally not covered by insurance because they haven't been approved as safe and effective by FDA regulators.

The Federal Food and Drug Administration (FDA) announced it had approved a new nasal spray for the treatment of long term depression.

But he hopes that doctors who are now using ketamine continue to do so.

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