FDA Approves Fast-Acting Nasal Inhaler Depression Drug


Hough said patients would receive the treatment two times a week for a month, then every week and then every other week, along with an oral antidepressant. "Also, it seems to work in 24 to 48 hours, so there's a very rapid resolution of symptoms".

Johnson & Johnson got some good news for a change as its antidepressant drug, called esketamine and branded Spravato, was fast-tracked through the FDA approval process and is now the first antidepressant to get approval since Prozac 30 years ago. That's about 5 million of the 16 million Americans with depression.

In the case of esketamine (sold as Spravato), one of these concerns is that it's related to ketamine, which has been used as an anesthesia and to get high in the form of the once-popular party drug Special K. There's a concern that this new antidepressant may carry a risk of addiction and substance abuse.

The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery.

In short, approvals for antidepressants have been few and far between, but with the rising number of people suffering depression, the antidepressant market is undoubtedly poised for growth.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", stated Tiffany Farchione, acting director of the FDA's Center for Drug Evaluation and Research - Division of Psychiatry Products.

The other two trials did not show statistically significant improvements over placebo. The drug can not be taken home for unsupervised use. Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder.

The drug will only be available through a restricted distribution system.

A clinical trial patient known as Robin P said the drug had a positive impact on him.

The FDA says the most common side effects of the drug observed in the trials included disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk. Patients are required to sign a form attesting that they understand they need to make arrangements to safely get home and that they can not drive or use heavy machinery on the day they receive the drug. "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". However, this does not provide a long term fix.