(Reuters) – The US Food and Drug Administration on Tuesday said it approved an antidepressant against Johnson & Johnson against people who are resistant to other treatments but put restrictions on the use of the drug, which it could be abused and abused. .
FILE PHOTO: A Johnson & Johnson building appears in Irvine, California, USA on January 24, 2017. REUTERS / Mike Blake / File Photo
The approval of nasal spray esketamine marks the first new type of treatment for depression of more than 30 years and has raised hopes for its relatively rapid action and ability to treat some otherwise inaccessible patients.
Esketamine should be sold under the brand name Spravato and is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational drug and goes along the street name "Special K". To prevent abuse, patients must take the drug at a doctor's office or hospital and cannot take home.
Currently available antidepressants such as Eli Lilly and Cos Prozac work on neurotransmitters such as serotonin and norepinephrine, but most drugs take at least four weeks to show efficacy and fail to provide an adequate response in about 30 percent to 40 percent of patients with major depressive disorder (MDD).
"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated thirds of people with major depressive disorder who have not responded to existing therapies," said Mathai Mammen, globally responsible for J & J's Janssen Research & Development.
Spravato has been named as an asset of blockbuster potential and is expected to improve investor sentiment towards the growth perspective of J & J's pharmacy Janssen, as its best-selling rheumatoid arthritis drug Remicade faces increased competition from cheaper biosimilar.
The treatment carries a boxed warning – the FDA's hardest – flag the risk of sedation and difficulty with attention, judgment and thinking, abuse and abuse and suicidal thoughts after drug administration.
Spravato is absorbed by the nasal adaptation lining and into the bloodstream and will be used in conjunction with a recently prescribed oral antidepressant, Johnson & Johnson noted in a statement here
During clinical trials, Spravato found relief of depression symptoms within 24 hours in some patients. patients, says Janssen spokesman Greg Panico.
The approval comes after an FDA advisory panel in February voted strongly for the esketamine drug and said its benefits were considering the risks.
However, panel members echoed issues raised by FDA staff regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study.
The drug is also tested in patients with depression who are at high risk of committing suicide.
New research shows that depression involves deterioration of the quality and number of nerve cell connections in areas of the brain that are related to mood. J & J's drug helps restore these neuronal connections in the brain, leading to an improvement in depression symptoms, according to the company. Over 300 million people live globally with major depressive disorders, and the incidence of suicide attempts in people with this disease is about 20 times higher than those who do not have the disorder.
Reporting of Saumya Sibi Joseph in Bengaluru; Editing by Cynthia Osterman and Lisa Shumaker