In Case You Missed It! – May 2022

If you’ve missed any of the latest news we’ve shared through our social media this month, don’t worry! Get up to date with this edition of “In Case You Missed It!”

  • TREATMENT PROGRESS: Jazz Pharma acquires development rights for oral orexin-2 receptor agonist.
  • TRIAL RESULTS: Data released from RESTORE and ARISE studies.
  • CURRENTLY RECRUITING: Two studies currently recruiting adult participants.
  • CONGRATULATIONS!: The Hypersomnia Foundation receives the AASM Foundation’s 2022 Sleep Champion Award!
  • INTERESTING READ: Can sleep become an addiction?
  • ADVOCACY ALERT: Ask your U.S. elected officials to support the HELP Copays Act.
  • FAMILY EVENT: Registration open for FREE weekend camp for kids with narcolepsy and other sleep disorders.
  • SCIENCE NEWS: New sleep molecule discovered.
  • FREE CME: HF is collaborating with Haymarket to provide continuing medical education about idiopathic hypersomnia.

Don’t worry if you’ve missed anything. We’ve got you covered!


JAZZ PHARMACEUTICALS ACQUIRES DEVELOPMENT RIGHTS FOR ORAL OREXIN-2 RECEPTOR AGONIST

Jazz Pharmaceuticals has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma’s investigational DSP-0187, now called JZP441, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders.

Orexin agonism is an exciting area of sleep disorder research and an approach that may be complementary to oxybate therapy. We believe that DSP-0187 has the potential to advance the treatment of narcolepsy and other sleep disorders based on its profile,” said Rob Iannone, MD, MSCE, Executive Vice President, Global Head of Research and Development of Jazz Pharmaceuticals.

Read the complete press release HERE.


DATA RELEASED FROM TWO STUDIES

Interim Date Released From Avadel’s RESTORE Study

Avadel Pharmaceuticals announced the presentation of interim data from the ongoing RESTORE study, which is an open-label extension/switch study of FT218, at the American Academy of Neurology Annual Meeting. For more information, read the article from the online edition of “Pharmacy Times.”

Results Released From ARISE Study

Real-world results from the ARISE study showed that idiopathic hypersomnia, an uncommon sleep disorder that causes excessive daytime sleepiness, is associated with a moderate to severe effect on quality of life, as demonstrated by responses on patient-reported outcomes. Despite a low percentage of patients missing work time due to their condition, a higher percentage reported impairment while working, overall work impairment, and activity impairment. For more information, read the complete article in a recent online edition of “Neurology Live.”


TWO STUDIES CURRENTLY RECRUITING

EXPLAIN Study Seeking Family Members of Adults With IH and Narcolepsy

The Behavioral Sleep Medicine Lab at Northwestern University is seeking participants for their EXPLAIN Study (Examination of Partners and Loved Ones of Adults with Idiopathic Hypersomnia and Narcolepsy), to learn how family members are affected by their loved one’s IH/narcolepsy, how family members provide support, and the types of support family members themselves need.

You may be eligible if: 1) You live in the United States; 2) You are an adult (18 or older); and 3) Your partner or adult family member has IH or narcolepsy.

Eligible volunteers will be asked to complete an online survey that will take approximately 15-minutes. Participants will not receive any compensation.

Visit “Currently Recruiting Studies” for more information.

INTUNE Study Initiates Phase 3 Trial of Pitolisant in Adults With IH

Harmony Biosciences announced the initiation of its Phase 3 trial evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia (IH), known as the INTUNE study.

“There has been much interest by both the patient community and healthcare professionals in pitolisant for the treatment of IH and we are excited about the initiation of our Phase 3 INTUNE study in adult patients with this rare neurological disorder,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “Given the novel mechanism of action of pitolisant, which works through histamine, an important wake-promoting neurotransmitter in the brain, we are looking to translate innovative science into therapeutic possibilities that have the potential to improve the health of people living with IH.”

The INTUNE study evaluating the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age ≥18 years.

This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.

This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or placebo (a tablet that does not contain study drug).

Visit “Currently Recruiting Studies for more information about the INTUNE study,


HYPERSOMNIA FOUNDATION RECEIVES 2022 SLEEP CHAMPION AWARD!

We are pleased to announce that the Hypersomnia Foundation has received the American Academy of Sleep Medicine (AASM) Foundation’s 2022 Sleep Champion Award!

Presentation of this honor will at an AASM Foundation Reception being held June 6th at 5:15-6:30 p.m. during the SLEEP 2022 Conference in Charlotte, NC.

We are grateful to everyone who supports our mission as we strive to get #BeyondSleepy.


CAN SLEEP BECOME AN ADDICTION?

A recent article in the online edition of “Psychology Today” asks the question, “Can sleep become an addiction?” Although the article states that an excessive desire to sleep doesn’t meet the criteria of addiction or substance use disorder, they do discuss that Sleep disorders are a major cause of sleep deprivation that can contribute to excessive sleep and excessive daytime sleepiness.

This is a great article to share with friends, family members, and even your physician. The article reminds the reader, “If your excessive daytime sleepiness has become noticeable or is affecting your day-to-day life, talk to your doctor or a sleep specialist as soon as possible. They can help you get to the root of the issue and get the treatment you need to get a good night’s sleep.”

Read the complete article HERE.


ASK YOUR U.S. ELECTED OFFICALS TO SUPPORT H.R. 5801, THE HELP COPAYS ACT

People living with serious, chronic health conditions often face skyrocketing deductibles and steep cost-sharing requirements, which for many is untenable without assistance. However, many health plans have changed the rules when it comes to patient assistance, by no longer allowing assistance received on behalf of a member to count towards their deductible and/or out of pocket responsibilities.

A new bill has been introduced in Congress that can put a stop to this. H.R. 5801, The HELP Copays Act would ban these practices. Please take a few minutes to reach out to your elected officials asking them to support the HELP Copays Act, so that these barriers are eliminated, and vulnerable patients are protected from unaffordable healthcare costs.

Details and more information, can be found HERE.


FREE WEEKEND CAMP FOR KIDS WITH NARCOLEPSY AND OTHER SLEEP DISORDERS

Registration is now open for the Wake Up Narcolepsy and The Center for Courageous Kids “Narcolepsy Family Weekend” – a fun-filled, FREE weekend retreat for kids with narcolepsy and other sleep disorders and their families. The camp is located in Scottsville, Kentucky and is scheduled for September 30 through October 2, 2022.

Connect with other families and create new friendships through workshops and discussion groups while also enjoying fishing, swimming, dancing, climbing, and horseback riding. For affected kids and their families, some of their anxieties and concerns can be significantly eased with the realization that sleep disorders affect others just like them.

For details and registration information, visit the Center for Courageous Kids website.


NEW SLEEP MOLECULE DISCOVERED

New sleep molecule discovered shows just how complex the machinery of sleep is. Researchers presents a new study demonstrating that a small molecule in brain cells affects the level of hypocretin, which is responsible for making us feel awake during the day and tired at night. People with a genetic variation of this molecule have a higher risk of suffering from daytime sleepiness.

Read the complete article in “Science Daily.”


HF IS PARTNERING WITH HAYMARKET MEDICAL EDUCATION TO PROVIDE CME ABOUT IDIOPATHIC HYPERSOMNIA

NOTE: The intended audience for this CME/CE certified symposium is sleep specialists, psychiatrists, neurologists, and advanced-practice clinicians.

This will be a complimentary accredited continuing education dinner symposium, “A New Dawn for Better Outcomes in Patients With Idiopathic Hypersomnia: New Data, New Guidance, New Treatments” being held on Sunday, June 5, 2022. The symposium is being presented at the SLEEP 2022 conference in Charlotte, NC, so it’s a great opportunity to participate in this CME event while also attending the HF Conference and/or SLEEP 2022 conferences.

REGISTER HERE for this FREE event.

  • WHEN – Sunday, June 5, 2022 / 6:30-7:00 p.m. Registration and Dinner / 7:00-8:30 p.m. Scientific Session
  • WHERE – The Westin Charlotte, Providence Ballroom, Charlotte, NC
  • PROGRAM DESCRIPTION – This CME/CE-certified industry-supported event presented at SLEEP 2022, chaired by Russell Rosenberg, PhD, FAASM, and in association with the Hypersomnia Foundation, consists of a lively evidence-based panel discussion among faculty experts (Anne Marie Morse, DO, FAASM, and Lynn Marie Trotti, MD, MSc) and a person with idiopathic hypersomnia, who will provide insights into their personal experiences with this disorder.
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