Daily Management Review

Anti-Depressant Nasal Spray By J&J Approved By US FDA


Anti-Depressant Nasal Spray By J&J Approved By US FDA
An antidepressant in eth form a nasal spray from Johnson & Johnson – aimed at providing a cure for those people who are resistant to other treatments, was approved by the United States Food and Drug Administration. The agency however also imposed certain restrictions on the manner of use of the new treatment fearing that it would be abused and misused.
It has been almost 30 years that the last innovative treatment type for depression was approved by the US agency – reflected by the new nasal spray esketamine treatment, and has increased the scope for relatively fast action and the possibility of treating those patients who were otherwise unreachable.
A chemical mirror image of anaesthetic ketamine, esketamine would be sold under the brand name Spravato. According to experts, anaesthetic ketamine is a drug treatment that is also misused and abused as a recreational party drug which is known as “Special K” on the street users. As a means to prevent such misuse, patients are regulated to take the medicine only and the office of the doctor or at a designated medical facility and it cannot be taken home.
Neurotransmitters like serotonin and norepinephrine are the targets of most of the currently available anti-depressants such as Eli Lilly and Co’s Prozac. However it is typically not before four weeks that the drugs show any impact and is also, on an average, they are unable to show the desired impact in 30 per cent to 40 per cent of patients who are patients of major depressive disorder (MDD).
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with a major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, global head of J&J’s Janssen Research & Development.
Experts have claimed that the spravato would prove to be a very critical asset for J&J and a possible blockbuster drug and would likely be able to enhance investor sentiment about the growth and development of J&J’s pharma unit Janssen. Doubts about the near and long term growth of J&J were being expressed because there is increased competition from cheaper biosimilars for the company’s block blaster rheumatoid arthritis drug Remicade.
Johnson & Johnson said in a statement that spravato be used along with a newly prescribed oral antidepressant and the drug would be absorbed by the lining of the nasal passages and thereby get diffused into the blood stream.
Janssen spokesman Greg Panico said that in some patients, the drug had clearly showed symptoms of relief within 24 hours during clinical trials.
In February, heavy favouritism in a voting was showed by an FDA advisory panel towards the drug esketamine arguing that the risks were lower than the prospective befits. That paved the path for the ultimate approval from the agency.
However concerns about the enhanced risks of sedation, dissociation and higher blood pressure that were observed during the study period were expressed by FDA staffers as well as the panel members. Sources said that the company is also conducting experiments of the drug among those patients who display a high risk of committing suicide.