FDA Approves Nasal Spray for Depression
The FDA has approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of adults with treatment-resistant depression.
However, the drug is only available through a restricted distribution system due to the risk of serious adverse outcomes and the potential for abuse and misuse, the FDA noted.
Patients must be monitored for at least 2 hours after receiving their esketamine dose and sign a Patient Enrollment Form agreeing to make arrangements to safely leave the health care setting and to avoid driving for the rest of the day.
The efficacy of the drug was evaluated in three 4-week clinical trials and 1 longer-term maintenance-of-effect trial. In the 3 short-term studies, patients were randomly assigned to receive Spravato or placebo. All patients started a new oral antidepressant at the time of randomization. In one of the short-term trials, treatment with esketamine resulted in a statistically significant effect on the severity of depression compared with placebo. In the long-term trial, patients who were in stable remission or with stable response who continued treatment with esketamine experienced statistically significant longer time to relapse than those taking placebo.
The most common adverse effects include disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic [press release]. March 5, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632761.htm?utm_campaign=030519_PR_FDA%20approves%20new%20nasal%20spray%20medication%20for%20treatment-resistant%20depression&utm_medium=email&utm_source=Eloqua.