ADHD Medication Approved: New Once A Day Formulation To Hit Market By End of 2021

What’s happening – The FDA approved Azstarys (formerly KP415), a new once-daily oral capsule treatment for ADHD in people aged 6 years and older. Azstarys is composed of KemPharm Inc.’s prodrug of d-methylphenidate (d-MPH), serdexmethylphenidate (SDX), which is combined with immediate-release d-MPH. Specifically, the new drug is 30% immediate-release d-MPH and 70% SDX, which is designed to convert to d-MPH and be released throughout the day. Corium will lead US commercialization efforts and the new ADHD medication may be available as early as the second half of 2021.

The details – Read the news releases from KemPharm and Corium.

Why it’s noteworthy – New ADHD medications including with IR formulations are needed, specifically in terms of “onset of action, duration of effect, and consistency of therapy,” according to Ann Childress, MD, an investigator in the Azstarys trial who was quoted in KemPharm’s announcement.

The conversation

  • @ADDitudeMag tweeted about FDA’s approval and linked to their coverage of the drug
  • @neuropsychblog, aka BrainBlog by Anthony Risser, PhD, noted the FDA’s decision on the drug and linked to the approval letter

In practice – A recent review looks at ADHD impact across the lifespan and, Randy Bressler, PsyD, provides a clinical primer on the most accurate ADHD assessment tools. See also, recent research on ADHD prevalence in Asian American children and how to talk to families about an ADHD diagnosis, and overlapping symptoms between ADHD, Autism, and Psychosis.

New Sleep Medications Pending, TBI Linked to Hypersomnia and Sleep Apnea Years Later

What’s happening – As we wrap up Sleep Awareness Week, with some of us still adjusting to Daylight Savings Time, let’s consider the activity we – and our clients – spend a third of our lives doing…unless a sleep disorder is present, that is.

To alleviate the burden of growing sleep disorders, FDA is considering two new medications for sleep disorders related to narcolepsy and hypersomnia. Excessive daytime sleepiness (EDS) is often the most obvious symptom of narcolepsy, and another symptom, cataplexy, refers to the sudden loss of muscle control often triggered by intense emotion. Idiopathic hypersomnia is a sleep disorder characterized by feeling excessively sleepy during the day despite adequate, or even prolonged, sleep at night.

Jazz Pharmaceuticals submitted its sNDA for calcium, magnesium, potassium, and sodium oxybates (Xywav) oral solution for the treatment of adult patients with idiopathic hypersomnia. If approved (Xywav was fast-tracked in September 2020 for idiopathic hypersomnia), it would be the first approved treatment in the US for adults with the condition. Xywav was approved in July 2020  for EDS and cataplexy in patients age 7 years and up who have narcolepsy.

FDA is also set to review Avadel Pharmaceuticals’ FT218 NDA, a once-nightly formulation of sodium oxybate for the treatment of EDS and cataplexy in adults with narcolepsy, in October 2021. If approved, the orphan-designated drug would be the first once-nightly oxybate medication and an improvement over the current standard twice-nightly regimen for the condition.

More trends in sleep research

  • A 14-year longitudinal study by Leng et al in Neurology of approximately 200,000 veterans uncovered an association between traumatic brain injury (TBI) and the development of sleep disorders, some occurring years after the injury. Comparing veterans with TBI to those without, researchers found that those with TBI were 41% more likely to develop a sleep disorder, such as sleep apnea, hypersomnia, insomnia, or sleep-related movement disorders. The association was stronger in those with mild TBI rather than moderate to severe TBI and did not differ by the presence of PTSD. Dr. Leng provides more detail in our Psy-Q below.
  • Another study involving veterans with TBI used a new MRI technique to investigate how sleep can help to heal the brain by clearing waste via the glymphatic system, published in the Journal of Neurotrauma by Piantino et al
  • A cross-sectional study appearing in the Journal of Clinical Sleep Medicine found a rise in sleep problems due to the pandemic.
  • Sleep is the topic of the latest issue of the journal Child and Adolescent Psychiatric Clinics of North America, titled “Sleep Disorders in Children and Adolescents.”

The conversation

  • @KristineYaffe, director of the @UCSF Center for Population Brain Health, and last author on the Leng paper, tweeted “Congrats to @YueLengsleep on this important new paper in @GreenJournal looking at the association between #TBI and incident #sleep disorders!”
  • @DrMikeRoizen, Chief Wellness Officer at Wellness Institute of the Cleveland Clinic, tweeted about the Leng study: “Trauma to the brain can have a lasting [impact] on your body, especially your brain. Recent research looked specifically at how veterans with traumatic brain injury (TBI) are at increased risk for developing sleep disorders, according to a study.”
  • @OHSUBrain (Oregon Health & Science University’s Brain Institute) tweeted about related research, stating “A study of military veterans suggests that sound #sleep may help in healing traumatic brain injuries (#TBI). The research was conducted by scientists at @OHSUnews, @UW and @VAPugetSound,” and linked to a news release about the study by Piantino et al.

In practice – See also, research on sleep, the glymphatic system and its role in cognitive decline and why people with schizophrenia experience insomnia, sleep apnea, and other sleep disorders.

Psy-Q: This Week's Challenge

After a traumatic brain injury (TBI), can a sleep disorder show up years later? Yue Leng, MD, PhD, answers.

Get the Answer

Emergency Rooms Struggle to Handle Influx of Teen Mental Health Crises

What’s happening – Emergency rooms have been overwhelmed by an increase of children and teens in psychiatric crisis due to the COVID pandemic, according to a NY Times report. Emergency departments (EDs) often do not have the resources or staff to focus on behavioral health issues, which was a problem before the pandemic that has only gotten worse in the past year. The article cites CDC data showing that ED visits for mental health issues rose 24% in young children and increased 31% for adolescents from April to October 2020, when compared to visits in 2019. Due to the shortage of resources, adolescents sometimes wait in the ED for days before a psychiatric bed opens up somewhere. As the article states, EDs have become “the first and sometimes last resort” for pediatric mental health for some families – including teen anxiety, depression, and suicidal ideation.

The details – Read the original New York Times report and CDC data.

The perspectives

  • The AP also reported on increased ER visits and waits for kids who need help with mental health including anxiety, depression, and suicidal ideation.
  • A recent Pediatrics study compared rates of youth suicidal ideation and attempts during 2020 and 2019 and found that increases in 2020 appeared to correspond to pandemic-related stressors.

Why it’s complicated – The anniversary of the start of the pandemic has brought a sense of reflection of what we’ve lived through, and in some, a feeling of anxiety about the milestone.

  • The University of Michigan’s S. Mott Children’s Hospital published the results of its National Poll on Children’s Health, finding that anxiety worsened or developed for 1 in 3 teen girls and 1 in 5 teen boys since March 2020.
  • Teens shared their stories, artwork, and memories of the past year of the pandemic in this article from the New York Times.
  • Anxiety screening can now be part of routine care at primary and/or gynecological checkups for women and girls aged 13 and up under the Affordable Care Act.
  • Teen Vogue wrote about anxiety leading up to the pandemic’s anniversary and explains a term that trauma experts call the “anniversary reaction.”

The conversation

  • @DrHyken ( Russell Hyken, who specializes in residential therapeutic placements) tweeted about the New York Times article “We’ve seen an #Increase in #SuicidalThoughts and #Attempts in the #Teen #Population. What’s happening with #Adolescents during the #Pandemic you might ask? Here’s some insight.”
  • The following physicians and organizations also tweeted about the Times article: @Innov_Clin_Neur (the journal Innovations in Clinical Neuroscience), @UCLASemelFriend (UCLA’s Semel Institute), @AliRaja_MD (emergency physician, professor @HarvardMed, vice-chair @MassGeneralEM, veteran USAF/#CCATT), and clinical psychologist @DrJephTausig
  • @WCAAP (The Washington Chapter of the American Academy of Pediatrics), @UMassMedCWM (the health care consulting and operations division of UMass Medical School), and @drglasofer (Deborah R. Glasofer PhD, clinical psychologist/assoc prof at Columbia University) all tweeted about the Mott poll.

In practice – See also, stimulant abuse among adolescents, a new suicide risk screening tool for teens and how it compares to the ASQ, Columbia Suicide Screen, and Risk of Suicide Questionnaire. Plus, how to use DBT to help teen anxiety, depression, and means reduction, and how to manage treatment adherence for anxiety in teens.


Last Updated: Jul 20, 2021