The Johnson & Johnson company Janssen Pharmaceuticals has just received FDA approval for its nasal spray for severe depression.
The prescription-only treatment, called Spravato, is designed to work in combination with oral antidepressants.
The pros and cons
The biggest advantage with an antidepressant nasal spray is how quickly it works. While oral antidepressants can take weeks to “kick in,” the nasal spray works fast enough that it could immediately help those contemplating suicide.
There are some concerns regarding the potential for abuse and serious side effects. Because of these safety concerns, the drug will need to be administered in a medical office to ensure the patient can be monitored for two hours after using the spray. Patients using the antidepressant nasal spray will be required to sign a paper promising not to drive or use heavy machinery for 24 hours.
The boxed warning label will highlight the risks to the user, including:
• attention and judgment problems
• dissociation
• sedation
• drug misuse
• suicidal thoughts and behavior
The randomized clinical trials
There was a long process for Spravato to get FDA approval. To start, researchers held three four-week randomized trials and one longer, the latter of which was to test the “maintenance of effect.”
Spravato was tested against a placebo and both were taken with an oral antidepressant throughout the trial. In one of the shorter trials, the patients taking Spravato showed improvement within two days. Compared to those taking the placebo with the oral antidepressant, study participants who took Spravato with an oral antidepressant showed “a statistically significant improvement” in depression severity.
There were some side effects in the trials, including: anxiety nausea and vomiting, vertigo, sedation, dizziness, disassociation, lethargy, decreased sensitivity, a sense of being intoxicated and increased blood pressure. Still, the side effects were tolerable enough for most participants to continue on with the study.
The announcement that the FDA approved Spravato has been met with mixed reactions, from skepticism and hesitation to hopefulness. Only time will tell if it can help the lives of people with severe depression.
