FDA approves Spravato, first monotherapy nasal spray to treat depression
Jan. 21 (UPI) -- The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression.
Johnson & Johnson's Spravato has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced Tuesday.
MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the United States living with the disease, according to Johnson & Johnson.
Spravato had been cleared in the United States in 2019 to be used together with an oral antidepressant for both treatment-resistant depression and for people with MDD.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients' much-needed symptom improvement," said Bill Martin, J&J's global therapeutic area head for neuroscience.
"Spravato is now available as a stand-alone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days -- without the need for daily oral antidepressants," Martin added.
The FDA approval of Spravato comes after a controlled study showed the nasal spray provided rapid improvement in the Montgomery-Asberg Depression Rating Scale, when compared with a placebo.
After four weeks, 22.5% of patients taking Spravato achieved remission or a MADRS score of less than 12, while only 7.6% of patients taking the placebo achieved similar results.
Spravato targets glutamate in the brain, which is the most abundant excitatory neurotransmitter.
Since there are some side effects, including sedation, respiratory depression and misuse, Spravato is only available through a restricted program.
The nasal spray has undergone more than a decade of research and nearly six years of real-world application. To date, Spravato has been administered to more than 140,000 patients worldwide.
"For more than six years, I've seen firsthand the real-world impact Spravato can have on patients' lives," said Gregory Mattingly, M.D., president of St. Charles Psychiatric Associates.
"Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs," Mattingly added.
"For the first time ever, we now have an option that gives patients freedom."
