Johnson & Johnson ketamine-derived nasal spray gets FDA approval for depression, but JNJ stock dips on earnings

On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray, Spravato (esketamine), to treat major depressive disorder.

Oral antidepressants are the most common treatment for depression, but they don’t work for everyone. Those who have tried at least two treatment options and have seen little improvement, or sometimes worsening mental health, are classified as having “treatment-resistant depression.” Around 21 million American adults have depression symptoms, and some estimates say of those, about a third (30.9%) don’t respond to treatment.

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine in Tuesday’s announcement. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement. 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.”

Spravato, which is derived from ketamine, is not a new drug—it first came on the market in 2019. The spray was previously approved as a companion treatment to an oral antidepressant, as well as a treatment for those experiencing thoughts of suicide or self-harm. But Tuesday’s clearance makes the spray the first stand-alone therapy for treatment-resistant depression.

The spray works differently than oral antidepressants. According to Johns Hopkins Medicine, while oral antidepressants can take weeks to take effect, Spravato patients can feel the drug’s impact “within hours.” Because the treatment can come with side effects, including sedation, drowsiness, and disassociation, patients need to be treated in a doctor’s office or hospital setting and remain in the clinic until the side effects have passed.

The nasal spray has been administered to more than 140,000 patients to date, and researchers say the results have been overwhelmingly positive. “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, Midwest Research Group and Founding Partner, St. Charles Psychiatric Associates in the announcement.

In 2023, the FDA warned of potential risks associated with ketamine treatments. “Known safety concerns associated with the use of ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression (slowed breathing), and lower urinary tract and bladder symptoms,” it said at the time.

Despite the approval, Johnson & Johnson’s stock (JNJ) dipped Wednesday after the company’s quarterly earnings release. Johnson & Johnson beat analyst expectations for revenue by $70 million, but highlighted possible negative impacts in its outlook from an ongoing talc lawsuit and slower medical device sales.