New drugs for depression! Johnson and Johnson Spravato Nasal Spray Approved by FDA: Treat patients with severe depression with emergency suicidal thoughts/behaviors!

!--, 2020 / -- Johnson and Johnson (JNJ) Janssen Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved Spravato (esketamine) CIII Nasal Spray Supplemental New Drug Application (sNDA), which is used in a combined way with oral antidepressants to treat adult patients with acute suicidal thoughts or behaviors with severe depression (MDD) and quickly reduce depressive symptoms.
in this challenging treatment population, Spravato's first medication showed improved depressive symptoms.
It's worth noting that Spravato is the first and only drug to be regulatoryly approved and has been shown to reduce depressive symptoms within 24 hours, providing a new approach to significantly alleviating symptoms until a long-term, comprehensive treatment program begins to work.
Spravato is the first antidepressant approved in more than 30 years with a new mechanism of action.
the United States and the European Union, Spravato was approved in March and December 2019, respectively, for oral antidepressants to treat adult patients with refractic depression (TRD).
depression is the leading cause of disability worldwide and the most common suicide-related disease.
MDD is a serious disease that has a significant negative impact on people's thinking, feelings and behavior.
symptoms and severity of MDD vary from person to person.
MDD patients assessed as having an imminent risk of suicide constitute a mental emergency that requires immediate intervention.
currently available antidepressants are effective in treating depression, they usually take weeks (4-6 weeks) to achieve full results.
risk of this delay, especially since the risk of suicide is highest in the early stages of treatment.
, Spravato offers the advantage of rapid potentiation through in-nasal administration compared to standard oral medications.
the effectiveness of Spravato in preventing suicide or reducing suicidal thoughts or behaviours has not been proven.
if clinically necessary, the use of Spravato does not preclude the need for hospitalization, even if the patient's symptoms improve after taking the initial dose of Spravato.
people living with depression are well aware of the feeling of despair," says Theresa Nguyen, chief program officer at the Mental Health American Institute.
if this severe depression develops into positive suicidal thoughts, it will be devastating, and these patients urgently need treatment options that can change the trajectory of acute depressive episodes.
traditional oral antidepressants take weeks or more to take effect, and Spravato can begin to relieve symptoms within a day of being given the drug, which has the potential to change a patient's life.
" new adaptation approval is based on positive results from two key Phase III clinical studies (ASPIRE I and II).
Both studies were double-blind, randomized, placebo-controlled, multi-center studies involving 456 adult patients with moderate to severe MDD, of whom more than 85 percent were rated moderate to extreme suicidal by clinicians.
study, all patients received a Comprehensive Standard Care Program (SOC), including first-time hospitalizations and newly started/or optimized antidepressant treatments.
these patients were randomly assigned to receive Spravato-SOC or placebo-SOC treatment.
end of the treatment was a reduction in depressive symptoms 24 hours after the first drug was given, measured using the Montgomery-Sberg Depression Assessment Scale (MADRS).
secondary endpoint was the use of a revised clinical overall clinical impression scale (CGI-SS-R) to measure the improvement in suicide severity 24 hours after the first drug was given.
it is worth noting that ASPIRE I and II are the first global clinical studies conducted in the group of patients with this serious disease, who are often excluded from antidepressant therapy studies.
results showed that Spravato nasal spray therapy rapidly reduced depressive symptoms in this group of high-risk patients when combined with a comprehensive SOC.
the results were that both studies reached their respective main therapeutic endpoints - the Spravato in-nasal spray 84mg-SOC treatment group had a statistically significant advantage in rapidly reducing depressive symptoms of MDD compared to the placebo-SOC treatment group.
data on reducing depressive symptoms were: in 2 studies, MADRS measurements were used 24 hours after the first dose, and the average difference between the Spravato-SOC treatment group and the placebo-SOC treatment group was 3.8 and 3.9 points, respectively, and the Spravato-SOC treatment showed significant effect on MDD symptoms 4 hours after the first dose.
between 4 hours and 25 days, both the Spravato treatment group and the placebo group continued to improve, and the degree of difference between the two groups remained largely the same over the 25-day double-blind period.
the end of the double-blind period, 54% of the Spravato treatment groups in the two studies had remission (MADRS score of 12 points).
2 treatment groups remained unchanged during the follow-up period of 9 weeks in the double-blind period.
secondary endpoint suicide severity improvement: the differences in treatment between the two groups were not statistically significant, possibly due to the substantial beneficial effects of the comprehensive SOC used in clinical trials, including the decentralized effect of inpatient psychiatric hospitalization on acute suicide crises in patients in both treatment groups.
2 studies, the Spravato-SOC solution was well-resistant and had no new safety signals.
the safety observed in two studies treating patients with strong suicidal thoughts MDD was consistent with previous clinical studies evaluating Spravato's treatment of resoicative depression (TRD).
The most common adverse reactions in the
Spravato-SOC treatment group were dizziness, dissocation, nausea, drowsiness, blurred vision, vomiting, sensory abnormalities, elevated blood pressure and sedation, with a rate of more than 2 times that of the placebo-SOC group.
!--/ewebeditor:page--!--webeditor:page-title-- Severe depression (MDD) is the leading cause of disability worldwide, affecting people of all ages.
suffer from severe illness, including MDD, which has a significant negative impact on physical function and all aspects of life.
antidepressants currently available are effective in many patients, they take four to six weeks to start and about one-third of patients do not respond to the treatments currently available.
Spravato's active pharmaceutical ingredient is esketamine, a non-competitive and subtype of non-selective activity-dependent N-methyl-D-tiandysteine (NMDA) affector antagonist with a unique new mechanism of action that works differently from other drugs currently on the market for depression.
NMDA receptor is a subtype of ionized glutamate receptor, which play a key role in the plasticity of synapses and the exchange of information between neurons.
in depression, it is thought that blocking NMDA can improve brain plasticity and enhance synact connections.
U.S., Spravato was approved in March 2019 for a combined oral antidepressant for the treatment of adult patients with refractic depression (TRD).
, the FDA had granted Spravato the right to treat TRD patients and to treat MDD patients with an imminent risk of suicide.
in the European Union, Spravato was approved in December 2019 for the treatment of adult patients with A combined selective 5-serotonin reuptake inhibitor (SSRI) or 5-serotonin and epinephrine reuptake inhibitor (SNRI).
, patients with depression are considered to have TRD if they do not respond to at least two different antidepressant medications during their current moderate to severe depressive episodes.
() Original source: Janssen Announces U.S. FDA approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideas or Behavior !--/ewebeditor:page