Avadel Pharmaceuticals Reveals Strong Preference for LUMRYZ™
Avadel Pharmaceuticals Announces RESTORE Data Release
In recent findings, survey data revealed that 94% of individuals diagnosed with narcolepsy showed a distinct preference for the once-nightly regimen of LUMRYZ over the traditional twice-nightly oxybate routines. These results, from the RESTORE study, underscore significant improvements in nocturnal experience and overall patient satisfaction.
Patient Insights on LUMRYZ™
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a notable biopharmaceutical enterprise committed to innovating treatment options, disclosed results from the RESTORE open-label study. The comprehensive research aimed to highlight patient preferences regarding the administration of sodium oxybate. LUMRYZ, recently approved by the FDA in 2023, stands as the pioneering once-nightly oxybate product, offering an alternative to the longstanding twice-nightly treatments that have dominated the market for over two decades.
The publication of these results, presented in the journal Sleep Medicine: X, further confirms that individuals transitioning to LUMRYZ reported being better able to sleep through the night—91% of participants noted improvements after the switch.
Challenges with Twice-Nightly Dosing
The RESTORE study uncovered critical challenges that patients face with the twice-nightly dosing of oxybates, particularly the disruptive nature of waking for a middle-of-the-night dose. Dr. Asim Roy, a contributing investigator, emphasized that participants highlighted increased feelings of grogginess and unsteadiness when they missed doses or took medications late at night.
Noteworthy Statistics from the RESTORE Study
The findings from the 129 participants who switched from twice-nightly oxybate regimens to once-nightly LUMRYZ revealed several important statistics:
- 69% reported missing their second oxybate dose, with 80% indicating a decline in symptom control on those days.
- Over half of the participants who delayed their second dose experienced significant grogginess the next morning.
- 92% of switch participants reported getting out of bed for the second dose, resulting in reports of falls and injuries among some individuals.
- 23% required assistance from another person to wake up for the middle-of-the-night dose.
Furthermore, among the 98 participants who completed the patient preference questionnaire, a staggering 94% expressed a clear preference for LUMRYZ.
LUMRYZ™: A Game Changer for Narcolepsy Treatment
As the only once-nightly treatment option on the market, LUMRYZ acts as a crucial breakthrough in the management of narcolepsy, effectively reducing the burden of nighttime dosing. Significant feedback also revealed that 93% of LUMRYZ users would recommend the product to friends or family members suffering from narcolepsy.
Understanding the Benefits of LUMRYZ™
The approval of LUMRYZ stemmed from results of the pivotal Phase 3 REST-ON trial, which demonstrated notable improvements in several key areas of narcolepsy symptoms:
- Excessive daytime sleepiness (EDS).
- Overall assessment by clinicians regarding patient functionality.
- Reduction in cataplexy attacks.
With the endorsement of the FDA, LUMRYZ not only provides a vital option for managing narcolepsy but is also accompanied by seven years of Orphan Drug Exclusivity, recognizing its clinical superiority over existing treatments.
Important Safety Information and Usage Instructions
It's crucial to remember that LUMRYZ, while effective, is a prescription medication and should be handled with care. Patients are advised to avoid concurrent use with other central nervous system depressants to prevent severe side effects. Misuse or abuse of the medication could lead to serious respiratory issues and other health complications. Patients should remain aware of the potential for dependence if the medication is not used as prescribed.
About Avadel Pharmaceuticals
Avadel Pharmaceuticals (Nasdaq: AVDL) is dedicated to transforming therapeutic solutions for patients with narcolepsy through innovative medications like LUMRYZ™. For further inquiries, you can reach out to Courtney Mogerley at (212) 698-8687 or via email.
Frequently Asked Questions
What is LUMRYZ™ used for?
LUMRYZ™ is used to treat cataplexy and excessive daytime sleepiness in adults with narcolepsy.
How does LUMRYZ™ compare to traditional oxybate treatments?
LUMRYZ™ offers a once-nightly dosing option, avoiding the need for a middle-of-the-night dose, which many patients find burdensome.
What is the major finding from the RESTORE study?
Many participants, 94%, expressed a preference for LUMRYZ over twice-nightly oxybate regimens due to improved nocturnal experience and daily functionality.
What are the potential side effects of LUMRYZ™?
Common side effects include nausea, dizziness, and bedwetting, among others. Serious side effects may also occur, particularly with misuse.
How long has LUMRYZ™ been available?
LUMRYZ was approved by the FDA on May 1, 2023, as a novel treatment option for narcolepsy.
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