FDA approves standalone use of J&J’s ketamine-derived depression treatment
/ Our Today
administrator
(Reuters)
The U.S. Food and Drug Administration has expanded the approval for Johnson & Johnson’s nasal spray Spravato to allow its standalone use in patients with depression, the company said on Tuesday.
The drug was previously approved in combination with antidepressants to treat symptoms in adults with major depressive disorder (MDD) who experienced suicidal thoughts or actions.
“Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs,” said Gregory Mattingly, founding partner of St. Charles Psychiatric Associates.
MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease, according to J&J’s estimates.
The approval is based on a study that showed Spravato helped reduce the severity of depressive episodes in patients compared to placebo. The drug works by targeting a neurotransmitter glutamate, which plays a role in depressive episodes.
Comments