In the meeting documents, the panel presented a scenario which illustrated their concerns regarding potentially complex drug interactions that may occur in the population for which the drug is intended.
The sNDA included findings from the RGH-MD-53, RGH-MD-54, and RGH-MD-56 trials in which cariprazine was associated with greater improvement in change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score vs placebo in bipolar I patients.
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
Overall, 4.4% of the fathers who answered the PSF screened positive for depression, which was comparable to the 5.0% of mothers who screened positive. Fathers accounted for 11.7% of all parents who screened positive for depression.
AGN-241751 is being developed in tandem with rapastinel, an investigational intravenous formulation of a novel NMDA receptor partial agonist, currently in Phase 3 development for MDD, as both a monotherapy and an adjunctive treatment.
The researchers found that depression or suicidal ideation did not differ at baseline for patients ever exposed to efavirenz versus those never exposed to efavirenz and receiving nevirapine.
ECT was projected to reduce time with uncontrolled depression from 50 to 33 to 37% of life-years over 4 years; greater improvements were seen when ECT was offered earlier.
In both studies, the primary efficacy endpoint was change from baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Compared to placebo, selective serotonin reuptake inhibitors (SSRIs) were associated with a significantly higher risk of headache (risk ratio [RR] 1.06, 95% CI: 1.00 to 1.13; P =.045).
The approval was based on data from the 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT, which investigated the effect of Trintellix on various aspects of cognitive function among adults aged 18 to 65 years with depression.
Results in the 202B and 202C trials showed that brexanolone achieved the primary endpoint of mean reduction from baseline in the Hamilton Rating Scale for Depression.
ALKS 5461 consists of a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
To determine the prevalence of DSM-5 MDD as well as DSM-5 specifiers, the study authors conducted "in-person interviews with a representative sample of US noninstitutionalized civilian adults (≥18 years) (n = 36 309) who participated in the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions III (NESARC-III)."
Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.
The NDA submission is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials.
"Our results show that, at a population level, prescriptions of stimulants and antidepressant medications for children and adolescents do not appear to be prescribed at rates higher than the known rates for psychiatric conditions they are designed to treat," said the study's lead author, Dr. Ryan Sultan.
The ketamine-treated patients demonstrated a clinically significant reduction in suicidal thoughts compared to the midazolam-treated patients within 24 hours (4.96 points greater reduction in SSI, 95% CI: 2.33, 7.59).
Researchers from the Perelman School of Medicine at the University of Pennsylvania analyzed 66 studies to determine the antidepressant effects of sleep deprivation.
Study authors reported evidence of greater opioid receipt among commercially insured patients with a wide range of psychiatric conditions.