HQ Team
January 21, 2025: The US Food and Drug Administration has approved Johnson & Johnson’s nasal spray in adults who have had an inadequate response to at least two oral antidepressants for treating major depressive disorder.
Spravato, chemically known as esketamine, is a CIII nasal spray and the first and only monotherapy for patients with the disorder, according to a company statement.
“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.
“For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” he said.
‘Improvement in 24 hours’
The spray is now available as a standalone treatment, and patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants.
Major depressive disorder is one of the most common psychiatric disorders, with an estimated 21 million adults in the US living with the disease. It is a mental illness that causes a persistent feeling of sadness and loss of interest. It can affect how you feel, think, and behave
About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected.
Globally, an estimated 5% of adults or an estimated 280 million people worldwide suffer from depression.
Loss of pleasure
Symptoms of the disease include angry outbursts, irritability or frustration even over small matters, loss of interest or pleasure in most or all normal activities, such as sex, hobbies or sports and sleep disturbances, including insomnia or sleeping too much.
Other indications of the disorder are tiredness and lack of energy, so even small tasks take extra effort and reduced appetite and weight loss or increased cravings for food and weight gain.
Johnson & Johnson’s FDA approval came after the spray showed a “rapid and superior improvement” in a depression rating scale across all 10 measurements at day 28. It was tested against a dummy drug.
Because of the risks of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse, to facilitate safe and appropriate use, the spray is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy Program.
Neurotransmitter
The medicine works by targeting glutamate, which is the most abundant excitatory neurotransmitter in the brain.
Approximately a third of adults with the disorder will not respond to oral antidepressants alone and are considered to have treatment-resistant depression, which is defined as an inadequate response to two oral medications.
Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief. After trying their third oral antidepressant, approximately 86% of patients do not achieve remission.
