Ketamine-based Nasal Spray Approved as Standalone Treatment for Depression
The FDA has approved Spravato, a ketamine-based nasal spray, as the first standalone treatment for treatment-resistant depression in the US, providing new hope for patients.
A ketamine-based nasal spray has become the first and only standalone therapy available for treatment-resistant depression in the US. Approved by the FDA in 2019 for use alongside oral antidepressants, the spray, known as Spravato (esketamine), can now be prescribed on its own.
Following a comprehensive review of 31 clinical trials over the past six years, the FDA has cleared the way for healthcare providers to offer Spravato independently. This allows for personalised treatment plans for patients who have failed to respond adequately to at least two antidepressants.
Some patients may find relief as quickly as 24 hours after their first dose. In a recent trial, 22.5 percent of those using Spravato achieved remission compared to just 7.6 percent of patients taking a placebo.
For over six years, the impact of Spravato has been evident, according to psychiatrist Gregory Mattingly, who participated in its initial trials. As healthcare providers can now use this as a monotherapy, it opens up new possibilities for tailored treatment strategies.
Despite the unknowns of how these drugs affect the brain, researchers are investigating the potential for esketamine to create new neural connections, contrasting with traditional treatments that enhance different chemical pathways.
While Spravato shows promise, it also comes with side effects, including sleepiness and dizziness, requiring patients to refrain from operating machinery for a day. Nevertheless, it represents a significant advance in the treatment landscape for those suffering from major depression.