Title: Ketamine Nasal Spray Emerges as Independently Effective Therapy for Severe Depression
A significant development in the treatment of clinical depression has been acknowledged recently. The Food and Drug Administration (FDA) has given its approval to Johnson & Johnson's (J&J) ketamine-based nasal spray, Spravato, as a solo therapy for depression instances that haven't responded to traditional methods.
J&J announced this supplemental FDA approval on Tuesday, extending Spravato's use beyond being an added treatment for treatment-resistant depression, when utilized in conjunction with an oral antidepressant. This expansion hints at a bright future for ketamine and similar medications in the mental health field.
Spravato initially gained FDA approval in 2019, following extensive research indicating that ketamine therapy could provide unique and swift antidepressant benefits. Although ketamine might be better known for its recreational uses and dissociative effects, it has long been used medically as an anesthetic. Prior to Spravato's approval, intravenous ketamine had emerged as a growing, if unapproved, option for challenging depression cases. However, Spravato consists of a distinct ketamine variant called esketamine.
Since its approval, Spravato and ketamine continue to exhibit their potential as a depression treatment. Research after its release has found that ketamine can outshine other standard alternatives for treatment-resistant depression, such as certain antipsychotics. The FDA approved Spravato's expanded use based on the results of another post-market phase 4 trial, which compared Spravato alone to a placebo.
This double-blind, randomized, and controlled trial involved people with treatment-resistant depression who were assigned to one of three groups: two groups that received varying doses of Spravato twice a week for four weeks and a control group that received a placebo spray. Those on Spravato showed a significant and sustained decrease in depression symptoms compared to controls. Only 7.6% of patients taking a placebo experienced a notable remission of their symptoms, compared to 22.5% of people taking Spravato. The drug was also found to be as safe as reported in earlier trials.
Bill Martin, the global therapeutic area head of neuroscience at J&J's innovative medicine department, stated, "Treatment-resistant depression can be intricate, especially for patients who do not respond to oral antidepressants or cannot tolerate them. Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the necessity of daily oral antidepressants."
Like any drug, ketamine isn't without its risks. Common side effects include sedation, dissociation, and respiratory depression (slow or shallow breathing). These side effects and the potential risk of harmful dependence have led to the FDA requiring a special strategy for administering Spravato to patients, known as a Risk Evaluation and Mitigation Strategy (REMS) program. Patients can only use Spravato at certified clinics or medical offices and under direct medical supervision.
However, Spravato's transformation into a standalone therapy means that more people with treatment-resistant depression will have access to the drug. In the long term, ketamine's potential to target different receptors in the brain linked to depression than other medications could lead to the development of newer drugs that work similarly. These drugs could eventually become frontline treatments for depression in general, if made even safer.
- Rapid improvement of depressive symptoms with Spravato, often within 24 hours and sustained through 28 days without the need for daily oral antidepressants.
- The easy-to-use nasal spray form of esketamine makes it a more convenient treatment option compared to intravenous ketamine.
- Spravato is the first and only FDA-approved monotherapy for treating adults with treatment-resistant depression, providing a standardized treatment option covered by most insurance plans.
- Healthcare providers can personalize treatment plans for individual patients based on their specific needs with the availability of Spravato as a monotherapy.
- Spravato is being rapidly expanded in clinics across the U.S., increasing accessibility for people with treatment-resistant depression.
- The most common adverse reactions for Spravato include sedation, dissociation, nausea, dizziness, headache, anxiety, vomiting, feelings of intoxication, increased blood pressure, and respiratory depression.
- Due to the risk of respiratory depression, Spravato must be administered under the direct supervision of a healthcare provider.
- With Spravato, there's a risk of abuse and misuse, necessitating a restricted program called the Spravato REMS.
- Spravato is administered via nasal spray, whereas intravenous ketamine is given as an IV infusion.
- Intravenous ketamine typically provides higher bioavailability, leading to faster onset and maximum effectiveness, but this requires more invasive administration.
- Both Spravato and intravenous ketamine necessitate monitoring, but Spravato must be administered in a certified healthcare setting under direct medical supervision for at least two hours.
- Initial Spravato treatment is twice a week, decreasing over time. Intravenous ketamine infusion schedules can vary, but they may require similar monitoring.
The expansion of Spravato's use signifies a promising future for technology and science in the field of mental health, as this ketamine-based therapy could potentially lead to the development of new depression treatments. With Spravato, patients can experience rapid improvement of depressive symptoms without the need for daily oral antidepressants, providing a more convenient treatment option compared to intravenous ketamine.
