Experts have said that while conventional antidepressants like the SSRIs or Fluoxetine or Paroxetine, Escitalopram etc. reduce depressive symptoms by increasing release of a chemical serotonin in the brain, Esketamine acts differently. That speed "is a huge thing because depressed patients are very disabled and suffer enormously", said Dr. John Mann, a psychiatrist and researcher at Columbia University. Because ketamine can cause hallucinations and out-of-body experiences, the new drug must be administered in a clinical setting.
One short-term trial that lasted four weeks determined that a combination of Spravato and an oral antidepressant demonstrated a "statistically significant effect" compared to a placebo.
Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening.
The FDA's approval of Spravato is only for patients with depression who have failed to find relief with at least two other drugs. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive.
The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression. Generic ketamine is approved as an anesthetic, not as an antidepressant. Meanwhile, esketamine delivers results within hours or a few days. "This has implications for treatment-resistant patients who have not responded to standard antidepressants, as esketamine potentially offers a better chance at achieving remission than traditional medications".
A decades-old drug, ketamine is already used off-label to treat depression by some doctors.
Drug addiction specialists and support groups like Nashville's Addiction Campuses are not for or against the new form of treatment.
Patients will inhale the drug under supervision at these centers once or twice a week. Such therapies are generally not covered by insurance because they haven't been approved as safe and effective by FDA regulators.
But he hopes that doctors who are now using ketamine continue to do so.
Controversial: The Food and Drug Administration approved a controversial drug for depression Tuesday that could be the first of a long-awaited wave of new treatments, but has also raised concerns about abuse, The Wall Street Journal reports. The AP is exclusively responsible for all content.