FDA Approves New Indication for Xywav, Social Media Backlash Ensues

What’s happening –The FDA approved Xywav (calcium, magnesium, potassium, and sodium oxybates; Jazz Pharmaceuticals) oral solution for a second indication: for adults with idiopathic hypersomnia, an uncommon chronic sleep disorder characterized by excessive daytime sleepiness, despite adequate sleep at night. Xywav is the first FDA-approved treatment for idiopathic hypersomnia, which affects an estimated 37,000 people, and the company plans to offer it to later this year after implementing a REMS program, according to a company press release.

Xywav was first approved (with orphan drug exclusivity) in July 2020 for excessive daytime sleepiness and cataplexy (sudden muscle weakness) in patients age 7 years and up who have narcolepsy.

Why it’s noteworthy – Jazz Pharmaceutical’s sodium oxybate (Xyrem) was also approved for excessive daytime sleepiness and cataplexy (back in 2002) but the drug carries a warning for its high sodium content. The Xywav formulation contains 92% less sodium than Xyrem, which may make it a better treatment option for people with cardiovascular conditions.

Reports and Perspectives

  • Sleep published a study by Bogan et al that examined the effectiveness and safety of Xywav (referred to as lower-sodium oxybate or LXB) for narcolepsy that found that it was effective and that the safety profile matched that of the older, higher-sodium Xyrem.
  • In another recent study from Sleep, Dauvilliers et al found that Xywav/LXB improved idiopathic hypersomnia symptoms, including excessive daytime sleepiness, and that the safety profile was consistent with its use for narcolepsy.
  • The New York Times covered the drug’s approval with the headline “F.D.A. Approves GHB, a ‘Date Rape’ Drug, for Rare Sleeping Disorder,” which not everyone in the hypersomnia community appreciated. Press releases from Jazz Pharmaceuticals state, “The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects,” but many in the sleep community took exception to the comparison of Xywav with ‘a date rape drug.’
  • The Hypersomnia Foundation issued a statement expressing its disappointment with the Times’ coverage of Xywav’s approval, saying that the article failed to explain the science and testing behind the drug and didn’t show an understanding of the realities of life with idiopathic hypersomnia.
  • The joyous mood stemming from Xywav’s approval was dampened by the New York Times article, wrote blogger Rey, who has idiopathic hypersomnia, in an article on Medium. She discussed the stigma that people with idiopathic hypersomnia face and the difficulties of getting a diagnosis, calling the Times article “a mess” of clickbait, dismissal, fearmongering, and suspicion without exploring what life with IH is really like.
  • @exoreys (Rey, the author of the Medium article) tweeted: “If there are doctors out there willing to immediately throw Xywav at anyone who says ‘I’m sleepy during the day,’ then they should be held accountable. But they aren’t the fault of IH patients.” My rebuttal of that awful @NYTScience article. #BeyondSleepy”
  • @IHAWeek (IH Awareness Week, which runs September 6-12) tweeted a reply to the Times article, in a thread that contains many opinions from IH patients, “Please stop tweeting that article. Apologize for the hurt it has caused, delete the article and publish a new one that leaves out all the fear-mongering and clickbait stuff and provides some balanced information about the challenges people with IH face.”
  • @katie_sharkey (Dr. Sharkey is assistant dean, Women in Medicine & Science @BrownMedicine and medical director of Brown’s Sleep for Science Research Lab) tweeted, “For @nytimes readers looking for *accurate* information about idiopathic hypersomnia, narcolepsy & the risks/benefits/side effects/alternatives of treatment options, here are some *reliable* sources: @AASMorg @ResearchSleep @sleepfoundation @ProjectSleep,” linking to this paper about treatments for patients with narcolepsy.

In Practice

Behavioral Health Home Programs Most Effective for SMI

What’s happening – People with serious mental illness (SMI) face a 20- to 30-year mortality gap due to factors such as reduced access to primary care, side effects of psychotropic medications, and lifestyle factors like smoking and obesity that increase risk for cardiovascular disease. Behavioral health homes (BHHs) combine primary, behavioral health, and wellness services as well as coordinated care teams with the hope that services will be used more frequently if they are easier to access. A study by Johnson et al followed adults with SMI for 3.5 years and evaluated their healthcare service utilization and cardiometabolic assessments.

The researchers found that enrollees in a BHH that integrated primary care into a specialty outpatient behavioral health setting showed increased primary care visits, a decrease in emergency department use, and a decrease in behavioral outpatient visits. They noted an improvement in hemoglobin A1c test results but not in the LDL cholesterol tests among those who engaged in BHH care.

Why it’s complicated – Johnson et al discuss the challenges of treating people with SMI and point out that BHH programs can improve health outcomes but their work must go beyond metabolic screening, for example, to provide interventions aimed at lowering identified risk factors. Future research should explore ways that BHHs can help to change behaviors for better cardiovascular health, for instance. More from Johnson in our Psy-Q below.

Reports and Perspectives

  • Presskreischer et al determined that outpatient mental health visits increased in a study of people with SMI enrolled in Maryland’s BHH program.
  • Enrollment in Maryland’s BHH programs was also associated with an increased probability of follow-up care after hospitalization for Medicaid enrollees with SMI, according to a study by Kennedy-Hendricks et al. The authors found that BHHs had no effect on the probability of readmission.
  • @AleneKH (Alene Kennedy-Hendricks, health policy researcher and lead author of the above study) tweeted in a thread about her team’s research, “To strengthen BHHs, policymakers might consider providing financial incentives to non-BHH providers to coordinate with BHHs and improving the infrastructure for communication and data-sharing across providers.”
  • Two BHH approaches, provider-supported care and self-directed care, were studied along with their impacts on service utilization and cost outcomes among adult Medicaid enrollees with SMI in a paper by Highland et al in Psychiatric Services. The authors found that both BHH approaches saved money and lowered the use of inpatient healthcare services.
  • @DrMattKukla (co-author on the above paper) tweeted, “Privileged to collaborate on this paper w/fantastic colleagues, evaluating behavioral health home approaches on health care utilization & costs for adult Medicaid benes w/serious mental illness” and linked to the team’s prior study in his thread.

In Practice

Psy-Q Challenge

Why might a Behavioral Health Home be most effective in managing serious mental illness (SMI)? Karl Johnson answers.

Get the Answer

As Kids Return to School, School Counselors Prepare for Challenges

What’s happening – As mask mandates and vaccination requirements continue to change during this back-to-school season, one thing is constant: the emphasis on the mental health of children and adolescents. For many youth, it’s a return to school after more than a year of remote learning with newfound anxiety, grief, and gaps in social skills.

School psychologists, counselors, and staff have been training to handle these new challenges. Teachers and administrators in Wisconsin received mental health training designed to help them feel prepared to identify and offer support to students. A South Carolina district has decided to add social-emotional learning to its school day using the “Let’s Talk” mental health program.  In Oklahoma, schools are partnering with nonprofits to hire mental health professionals. New Jersey school districts are using federal funding to provide more support for students’ mental health. Officials in Idaho are asking what it would take to fully staff mental health professionals in its schools, which are described as “woefully short on counselors and psychologists at a time when students need support for mental and emotional health more than ever.” And Illinois passed a law granting 5 mental health days to students.

USA Today addressed the well-known scarcity of mental health resources for many students while PBS further reported on how school counselors and teachers are preparing for the upcoming school year by focusing on mental health.

Why it’s complicated – Reports of increased suicides and suicidal ideation among children and teens make the added stressors of the pandemic on mental health all the more urgent. The mental health crisis will grow this fall, writes the New York Times; a report from South Carolina’s The State points out that pressure on kids comes not only from the pandemic but also from a divisive political climate and the effects of racism; and WBUR News profiled a Massachusetts teen after a suicide attempt.

Back to School Resources for School Psychologists

In Practice

 

 

Last Updated: Sep 1, 2021