Johnson & Johnson has stated that the name brand of esketamine, which will be administered via nasal spray, will be Spravato.
Good thing the Food and Drug Administration (FDA) recently approved another medication, which can help people who are dealing with the said mental illness, especially those whose body is resistant to most traditional antidepressant meds.
"Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient", Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA Center for Drug Evaluation and Research, said in a statement.
The drug will come with a label warning patients that it has the potential to be abused or misused. The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray can not be taken home. STAT reports that the announcement will leave biotech and pharma executives, as well as health care investors, "nervous at best and frightened at worst".
The efficacy of Spravato was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. After continuing Spravato as a treatment and were shown to be 51% less likely to relapse compared patients given a placebo and oral antidepressant. Side effects may include sedation and dissociation, and as such patients are required to stay with a professional caretaker for two hours after taking the medication.
The drug was first developed and approved by the FDA to be used in surgeries in 1962, as a safer alternative to the anesthetic phencyclidine, AKA PCP.
The effectiveness of the previous class of antidepressants, like Prozac and Paxil, was wildly exaggerated when they first hit the market, and the results of esketamine trials, which were paid for by the Johnson & Johnson affiliate, have been mixed.