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 The approval of nasal spray esketamine marks the first new type of
treatment for depression in more than 30 years and has raised hopes
for its relatively fast action and ability to treat some otherwise
unreachable patients.
Esketamine would be sold under the brand name Spravato and is a
chemical mirror image of anesthetic ketamine, which is also abused
as a recreational party drug and goes by the street nickname
"Special K". To prevent abuse, patients must take the drug in a
doctor's office or medical facility and cannot take it home.
Currently available anti-depressants such as Eli Lilly and Co's
Prozac work on neurotransmitters like serotonin and norepinephrine,
but most drugs take at least four weeks to show effect and fail to
produce 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 one-third of people with major
depressive disorder who have not responded to existing therapies,"
said Mathai Mammen, global head of J&J's Janssen Research &
Development.
Spravato has been touted as an asset with blockbuster potential and
is expected to improve investor sentiment toward the growth
prospects of J&J's pharma unit Janssen, as its top-selling
rheumatoid arthritis drug Remicade faces increased competition from
cheaper biosimilars.
The treatment carries a boxed warning - FDA's harshest - flagging
the risk for sedation and difficulty with attention, judgment and
thinking, abuse and misuse, and suicidal thoughts after
administration of the drug.
Spravato is absorbed by the lining of the nasal passages and into
the blood stream and will be used along with a newly prescribed oral
antidepressant, Johnson & Johnson said in a statement
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During clinical trials, Spravato was found to relieve depression
symptoms within 24 hours in some patients, said Janssen spokesman
Greg Panico.
The approval comes after an FDA advisory panel in February voted
heavily in favor of the drug esketamine, saying its benefits
outweighed the risks.
However, the panel members echoed concerns raised by FDA staffers
regarding the increased risk of sedation, dissociation and higher
blood pressure observed in the study.
The drug is also being tested in patients with depression who are at
a high risk of committing suicide.
Recent research shows that depression involves deterioration of the
quality and number of nerve cell connections in areas of the brain
related to mood. J&J's drug helps restore these nerve cell
connections in the brain, leading to an improvement in depression
symptoms, according to the company. Over 300 million people globally
live with major depressive disorders, and the incidence of attempted
suicide in people with this condition is about 20-fold higher than
that among those without the disorder.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Cynthia
Osterman and Lisa Shumaker)
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