(Reuters) – The US Food and Drug Administration said on Tuesday it approved an antidepressant for Johnson & Johnson nasal spray for people who are resistant to other treatments, but put restrictions on the use of the drug, which it warned could be abused and abused. .
FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, USA, January 24, 2017. REUTERS / Mike Blake / File Photo
Approval of nasal spray esketamine marks the first new type of treatment for depression more Than 30 years and has increased the hope of their relatively rapid action and ability to treat some otherwise unattainable patients.
Esketamine will be sold under the brand name Spravato and is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational subject and bypasses the street name "Special K". To prevent abuse, patients must take the drug at a doctor's office or medical facility and cannot take it home.
Currently available anti-depressants 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 a sufficient 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 give new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies," said Mathai Mammen, global leader of J & Js Janssen Research & Development.
Spravato has been named as a resource of blockbuster potential and is expected to improve investor sentiment towards the growth prospects of J & J's pharma unit Janssen, as its best-selling rheumatoid arthritis remicade drug Remicade faces increased competition from cheaper biosimilar products.
The treatment carries a book alert – the FDA's hardest – flag the risk of sedation and difficulty with attention, assessment and thinking, abuse and abuse, and suicidal thoughts after drug administration.
Spravato is absorbed by the lining of the nasal passages and into the bloodstream and will be used with a recently prescribed oral antidepressant, Johnson & Johnson said in a statement here
During clinical studies, Spravato was found to relieve depression symptoms within 24 hours. in some patients, says janssen spokesman Greg Panico.
The approval comes after a February FDA advisory panel voted heavily for drug esketamine and said the benefits outweighed the risk.
However, panel members echoed concerns about FDA staffers regarding increased risk of sedation, dissociation and higher blood pressure observed in the study.
The drug is also tested in patients with a high risk of suicide.
Recent research shows that depression involves worsening the quality and number of nerve cell connections in brain areas related to mood. J & J's drugs help restore these neuronal connections in the brain, leading to an improvement in depression symptoms, the company said. Over 300 million people live globally with major depressive disorders, and the incidence of suicide attempts in people with this condition is about 20 times higher than that of those without disorder.
Reporting of Saumya Sibi Joseph in Bengaluru; Editing by Cynthia Osterman and Lisa Shumaker