The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug.
The 7 treatments included in the study were amphetamines (including lisdexamfetamine), atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil.
Jornay PM utilizes the proprietary Delexis drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day.
Using data from the 2012 and 2013 National Ambulatory Medical Care Surveys, researchers looked at all adult outpatient visits to psychiatric practices for chronic care management in which ≥1 psychiatric medication was prescribed.
There was a correlation for high-frequency engagement in each additional digital media activity at baseline with a significantly increased odds of having ADHD symptoms across follow-up (odds ratio, 1.11).
The correlation between gestational age at birth and symptoms of ADHD in preschool and school-age children was compared after adjustment for unmeasured genetic and environmental risk factors.
The researchers found that 11 of 20 studies that reported estimates for ASD (777,518 participants) found higher odds with HDP (adjusted odds ratio [aOR], 1.35) in pooled analysis. For the 6 studies reporting adjusted estimates of ADHD (1,395,605 participants), the pooled adjusted OR was 1.29.
Asthma medications, antibiotics, attention-deficit/hyperactivity disorder (ADHD) medications, topical agents, and antihistamines were the most commonly used medication classes in 2011 to 2014.
The researchers found that 45.3% of the 3,319 children included in the analysis had ADHD. Comorbid ADHD increased with age (P<0.001) and was associated with increased ASD severity.
The researchers found that 25.7% of the 187 children met the definition of SADHD. Compared with the OI group, severe TBI correlated with SADHD (hazard ratio [HR], 3.62; 95% confidence interval [CI], 1.59 to 8.26).
The once-daily medication uses the same modified-release drug delivery technology seen in Adzenys XR-ODT (amphetamine) Extended-Release Orally Disintegrating Tablets.
The ASD group had a shorter duration of ultrasound exposure than the typical development group during the first (290.4 versus 406.4 seconds) and second (1,687.6 versus 2,011 seconds) trimesters. Greater mean depth of ultrasonographic penetration was seen in the ASD group versus the developmental delay group in the first trimester (12.5 versus 11.6 cm).
"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.
Results showed that after adjusting for maternal use of acetaminophen pre-pregnancy, familial risk and indications of acetaminophen use, the hazard ratio (HR) of ADHD with ≥29 days of acetaminophen use was 2.20 (95% CI; 1.50-3.24).
Researchers analyzed prevalence and correlates of discordant responses among past-year Adderall users, defined as reporting past-year nonmedical Adderall use but not past-year nonmedical amphetamine use.
Cotempla XR-ODT is a Schedule II controlled substance and is supplied as 8.6mg, 17.3mg, and 25.9mg strength orally-disintegrating tablets in cartons containing 5 blister cards of 6 tablets each.
Two year-long studies assessing safety of dasotraline in children, adolescent and adult ADHD patients found the treatment to be generally well tolerated.
"In two genetically related cohorts at high risk for autism spectrum disorder, reciprocal neuroanatomic abnormalities were found and determined to be associated with cognitive and behavioral impairments," the authors write.
In both studies, more participants on LDX versus placebo were categorized as improved on the Clinical Global Impressions-Improvement starting at week one.
"Importantly, the absolute risk of autism was small, and, hypothetically, if no pregnant women took antidepressants, the number of cases that could potentially be prevented would be small," wrote the authors of the study.