Study Highlights Challenges Faced by Narcolepsy Patients on Twice-Nightly Sodium Oxybate Therapy
Table of Contents
- Study Highlights Challenges Faced by Narcolepsy Patients on Twice-Nightly Sodium Oxybate Therapy
- New Sleep Disorder Treatment Offers Relief for Narcolepsy Patients
- FDA Approves LUMRYZ for Narcolepsy Treatment: A Game-Changer in Patient Care
- New Sleep Disorder Treatment LUMRYZ Raises Concerns and Offers Hope
- Company Issues Cautionary Statement on Forward-Looking Projections
– Research published in Brain Sciences reveals critically important adherence issues adn potential risks for patients taking twice-nightly sodium oxybate –
DUBLIN, Dec. 11, 2024 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company dedicated to improving patient outcomes, has released findings from a extensive study exploring the challenges faced by individuals with narcolepsy who take twice-nightly sodium oxybate. The research, which combined social media analysis and a survey of patients, highlights significant adherence issues and the potential for negative impacts on patients’ lives.
The standard dosing regimen for twice-nightly sodium oxybate involves taking the first dose at bedtime and a second dose 2.5 to 4 hours later. However, the study found that many patients struggle to consistently follow this regimen, leading to missed doses and suboptimal treatment outcomes. The findings were published in the journal Brain Sciences under the title “Understanding the Patient Experience With Twice-Nightly Sodium Oxybate Therapy for Narcolepsy: A Social Listening Experiment.”
“These findings clearly illustrate the importance of listening and learning from the lived experience of individuals living with a chronic disease like narcolepsy. Narcolepsy steals away time and predictability in a day,is socially isolating and carries a high degree of burden,which includes barriers to access of optimal care and treatments. Therefore,some individuals may hesitate to share all aspects of their lived journey with their provider but are more open in social media forums,providing them social support while also exposing critical care gaps and impediments. Social media listening is a valid data science that provides these insights, and also prospect to intervene, such as is the case we have seen here with oxybate medications,” said Anne Marie Morse, DO, a board-certified and fellowship-trained pediatric neurologist and sleep medicine specialist at Geisinger.
Dr. Morse emphasized the need for healthcare providers to reevaluate their practices and interaction strategies to better support patients. “As sleep clinicians, we have normalized waking up in the middle of the night to take a second dose of oxybate medications, as it was the only option for decades. This research is a call to action to re-evaluate our practices and quality of communication. We can best partner with patients by inviting the opportunity to freely communicate challenges, discuss alternatives and plan together for their next steps. Inconsistent adherence, including missing doses or improper timing between doses, only augments the vulnerability to inconsistencies a person may feel living with narcolepsy and results in sub-optimal management both pharmacologically and psychologically. A single-dose oxybate treatment option should be considered for appropriate people with narcolepsy to decrease the burden, optimize safety and perhaps improve a sense of predictability,” Dr. Morse added.
Methodology and Key Findings
The study utilized open-source natural language processing techniques to analyze social media conversations from two platforms: a private Facebook group called “People with Narcolepsy for People with Narcolepsy (PWN4PWN)” and a public subreddit, “r/narcolepsy.” The data, spanning over 11 years (August 2011 to October 2022), focused on discussions related to twice-nightly sodium oxybate therapy.
A subsequent survey was conducted among members of PWN4PWN from October 12 to November 6, 2022. The survey included 87 participants aged 18 or older, either currently taking or previously taking twice-nightly oxybate therapy, or caregivers of narcolepsy patients.Key findings from the survey include:
- 75.3% of respondents reported accidentally missing their second dose of oxybate therapy.
- 37% of participants missed their second dose once a week or more ofen, while 28% missed it once per month.
- The consequences of missed doses included increased daytime sleepiness and a diminished sense of control over their condition.
The study underscores the need for improved treatment options and better patient support to address the challenges of twice-nightly dosing. Avadel Pharmaceuticals is committed to advancing research and developing innovative solutions to improve the lives of individuals with narcolepsy.
For more data on the study and its findings, visit www.avadel.com.
New Sleep Disorder Treatment Offers Relief for Narcolepsy Patients
A groundbreaking new treatment for narcolepsy is offering hope to patients struggling with excessive daytime sleepiness and cataplexy. LUMRYZ™, an extended-release sodium oxybate medication, has been approved by the FDA as the first and only once-at-bedtime treatment for these symptoms in adults with narcolepsy. The approval, granted on May 1, 2023, marks a significant milestone in the management of this chronic sleep disorder.
Narcolepsy, a neurological disorder characterized by excessive daytime sleepiness (EDS) and sudden loss of muscle control (cataplexy), has long posed significant challenges for patients. Traditional treatments frequently enough require patients to take medication twice a night, disrupting sleep and leading to a host of related issues.
Challenges with Current Treatments
Recent research highlights the difficulties patients face with current twice-nightly oxybate formulations. A survey of narcolepsy patients revealed that nearly three-fourths reported improper timing of their second dose, with over half taking it too late and a significant portion taking it too early. These timing issues led to a range of problems, including missed activities, grogginess, and even fear and anxiety.
Additionally, nearly one-third of respondents reported experiencing injuries such as falls, bumps, and bruises after waking to take their second dose. These findings underscore the need for a more patient-pleasant treatment option.
Introducing LUMRYZ™
LUMRYZ™ addresses these challenges by allowing patients to take a single dose at bedtime. This approach not only simplifies the treatment regimen but also reduces the risk of missed or improperly timed doses. jennifer Gudeman, PharmD, Senior Vice President of Medical and Clinical Affairs at Avadel, emphasized the significance of this innovation.
“This research confirms what we have consistently heard first-hand from patients and observed in our RESTORE study – there are many challenges associated with chronically waking up to take a dose of oxybate medication in the middle of the night, ranging from completely missed doses, doses taken too late, with next day implications, and/or a dose taken too early, with the potential for CNS depression and associated risks. Once-at bedtime LUMRYZ™ obviates these issues.”
LUMRYZ™ has been shown to significantly improve cataplexy and excessive daytime sleepiness symptoms, alleviating many of the treatment burdens associated with twice-nightly oxybates. The medication is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to its potential for abuse and misuse.
Clinical Trials and FDA approval
The FDA’s approval of LUMRYZ™ was supported by results from the REST-ON Phase 3 trial, a randomized, double-blind, placebo-controlled study. The trial demonstrated statistically significant and clinically meaningful improvements in key endpoints, including EDS, clinicians’ overall assessment of patients’ functioning, and cataplexy attacks. These findings were consistent across all evaluated doses of LUMRYZ™.
In addition to its approval for adults, LUMRYZ™ was granted approval for pediatric patients aged 7 and older on October 16, 2024. This extended approval underscores the medication’s broad applicability and effectiveness in managing narcolepsy symptoms across different age groups.
Looking Ahead
With its unique once-at-bedtime dosing regimen,LUMRYZ™ represents a significant advancement in narcolepsy treatment. By addressing the logistical and safety challenges associated with current therapies, LUMRYZ™ offers patients a more manageable and effective option for managing their condition. As the first of its kind, LUMRYZ™ is poised to transform the landscape of narcolepsy care, providing much-needed relief to those affected by this debilitating disorder.
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ™ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ™ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.
FDA Approves LUMRYZ for Narcolepsy Treatment: A Game-Changer in Patient Care
In a groundbreaking move, the U.S. Food and Drug Governance (FDA) has approved LUMRYZ (sodium oxybate) for extended-release oral suspension, marking a significant advancement in the treatment of narcolepsy. This once-nightly dosing regimen offers a transformative approach to managing symptoms such as cataplexy and excessive daytime sleepiness (EDS) in patients aged 7 years and older.
The FDA’s approval highlights LUMRYZ’s unique ability to provide a single-dose solution, eliminating the need for nocturnal arousal associated with twice-nightly oxybate treatments. This innovation not only enhances patient convenience but also significantly improves adherence to treatment protocols.
Key Indications and Benefits
LUMRYZ is specifically designed to address the following symptoms in narcolepsy patients:
- Sudden onset of weak or paralyzed muscles (cataplexy)
- Excessive daytime sleepiness (EDS)
The approval also comes with a second 7-year period of Orphan Drug Exclusivity, granted in October 2024, further solidifying LUMRYZ’s position as a leading treatment option in the management of narcolepsy.
Crucial Safety Information
While LUMRYZ offers significant benefits, it is indeed crucial for patients and caregivers to be aware of its safety considerations.The medication contains sodium oxybate, a form of gamma hydroxybutyrate (GHB), which is a controlled substance. As such, it carries potential risks, especially when combined with other central nervous system (CNS) depressants.
The FDA warns that taking LUMRYZ with other CNS depressants, including opioids, benzodiazepines, and sedating antidepressants, can led to serious complications such as respiratory depression, hypotension, drowsiness, syncope, and even death. Patients are advised to consult their healthcare providers about potential interactions and to report any adverse effects immediately.
Additionally, LUMRYZ is available only through certified pharmacies as part of the LUMRYZ REMS (Risk Evaluation and Mitigation Strategy) program. Patients must be enrolled in this program to receive the medication, ensuring strict adherence to safety protocols.For more information, visit www.LUMRYZREMS.com or call 1-877-453-1029.
Contraindications and Precautions
LUMRYZ is contraindicated in patients taking other sleep medicines or sedatives, those who consume alcohol, or individuals with succinic semialdehyde dehydrogenase deficiency. It is essential to store LUMRYZ in a secure location to prevent abuse and misuse, as selling or giving away the medication is illegal and can harm others.
Patients should also be cautious about engaging in activities requiring full alertness, such as driving or operating heavy machinery, for at least six hours after taking LUMRYZ. The medication’s rapid onset of sleep can lead to falls and injuries, particularly in individuals who may fall asleep while standing or transitioning from bed.
Serious Side Effects
LUMRYZ can cause serious side effects, including:
- breathing problems, such as slower breathing, trouble breathing, and sleep apnea, particularly in patients with pre-existing respiratory or lung conditions.
- Mental health issues,including confusion,hallucinations,abnormal thinking,anxiety,depression,suicidal thoughts,and difficulty concentrating.
Patients experiencing any of these symptoms should contact their healthcare provider immediately.
A New era in Narcolepsy Treatment
The approval of LUMRYZ represents a major step forward in the treatment of narcolepsy, offering patients a more convenient and potentially safer option. With its once-nightly dosing and comprehensive safety measures, LUMRYZ is poised to become a cornerstone in the management of this chronic neurological disorder.
As the narcolepsy community embraces this new treatment, healthcare providers and patients alike can look forward to improved outcomes and a better quality of life.
For more information on LUMRYZ and its availability, visit www.LUMRYZREMS.com or speak with your healthcare provider.
New Sleep Disorder Treatment LUMRYZ Raises Concerns and Offers Hope
A groundbreaking new treatment for narcolepsy, LUMRYZ, has recently hit the market, offering hope to patients suffering from cataplexy and excessive daytime sleepiness (EDS). Though, the medication comes with a host of potential side effects and warnings that patients and healthcare providers need to be aware of.
LUMRYZ,developed by Avadel Pharmaceuticals plc,is the first and only once-at-bedtime oxybate approved by the U.S. Food and Drug Administration (FDA) for both adults and pediatric patients aged 7 and older. The drug aims to simplify treatment for narcolepsy, a chronic neurological disorder that affects the brain’s ability to regulate sleep-wake cycles.
Key Warnings and Side Effects
While LUMRYZ offers a new approach to managing narcolepsy,it is not without risks. The FDA has issued a boxed warning, emphasizing the potential for serious side effects, including:
- Mental Health Issues: Patients with a history of depression or suicidal thoughts should exercise caution. “Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite,” advises the FDA.
- Sleepwalking: Sleepwalking, a known side effect, can lead to injuries. “Call your doctor if you or your child start sleepwalking,” the FDA recommends.
Additionally, LUMRYZ contains a high level of sodium, making it unsuitable for individuals on salt-restricted diets or those with conditions such as high blood pressure, heart failure, or kidney problems.
Common Side Effects
The most common side effects reported in adults include nausea, dizziness, bedwetting, headache, and vomiting. In children,these symptoms are accompanied by decreased weight,decreased appetite,and sleepwalking. Higher doses of LUMRYZ may exacerbate these effects.
LUMRYZ can also lead to physical dependence and cravings if not taken as prescribed. “These are not all the possible side effects of LUMRYZ,” the FDA warns, encouraging patients to consult their healthcare provider for more information.
About Avadel Pharmaceuticals
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company dedicated to improving patient outcomes through innovative treatments. LUMRYZ represents a significant milestone for the company, offering a new option for narcolepsy patients who previously relied on more complex treatment regimens.
For more information about LUMRYZ, visit www.avadel.com.
Forward-Looking Statements
This article includes forward-looking statements about the potential benefits and market impact of LUMRYZ. These statements are based on current expectations and are subject to risks and uncertainties.Avadel cautions that actual results may differ from these projections.
As with any new medication,patients and healthcare providers must weigh the potential benefits against the risks. LUMRYZ offers a promising solution for narcolepsy,but its use should be carefully monitored to ensure patient safety.
For medical advice about side effects, call your doctor.To report negative side effects, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Company Issues Cautionary Statement on Forward-Looking Projections
in a recent disclosure, the company has issued a cautionary statement regarding its forward-looking projections.These projections are based on estimates and assumptions derived from the company’s current understanding of its buisness and operations.However,given the inherent risks and uncertainties associated with the industry,there is no guarantee that actual outcomes will align with these forward-looking statements.
The company emphasized that its business is subject to significant risks, which could lead to material differences between projected and actual results. To provide transparency, the company referenced the “Risk Factors” section of its Annual Report on Form 10-K for the year ending December 31, 2023. This report, filed with the Securities and Exchange Commission (SEC) on Febuary 29, 2024, outlines various risks and uncertainties that could impact future performance.
Forward-looking statements,the company noted,are not guarantees of future performance and should not be relied upon as such.The company further stated that it does not intend to update or revise these statements publicly unless required by law.
Investor and Media Contacts
Investor Contact:
Austin Murtagh
Precision AQ
[email protected]
(212) 698-8696
Media Contact:
Lesley Stanley
Real chemistry
[email protected]
(609) 273-3162
investors and stakeholders are advised to carefully consider the risks outlined in the company’s SEC filings before making any decisions based on forward-looking statements.
It seems like you’ve provided a detailed text about LUMRYZ, a new treatment for narcolepsy, including it’s benefits, contraindications, side effects, and safety measures. here’s a summary of the key points:
### Key Points about LUMRYZ:
1. **Program Enrollment**:
– Patients must enroll in the LUMRYZ REMS (Risk Evaluation and Mitigation Strategy) program to receive the medication.
– This ensures strict adherence to safety protocols.
2. **Contraindications and Precautions**:
– LUMRYZ is contraindicated for patients taking other sleep medicines or sedatives, those who consume alcohol, or individuals with succinic semialdehyde dehydrogenase deficiency.
- It should be stored securely to prevent abuse and misuse.
– Patients should avoid activities requiring full alertness (e.g., driving) for at least six hours after taking LUMRYZ due to its rapid onset of sleep.
3. **Serious Side Effects**:
– Potential side effects include breathing problems (e.g.,slower breathing,sleep apnea),mental health issues (e.g., confusion, hallucinations, suicidal thoughts), and sleepwalking.
– Patients experiencing thes symptoms should contact their healthcare provider immediately.
4. **FDA Approval and Benefits**:
– LUMRYZ is the first and only once-at-bedtime oxybate approved by the FDA for both adults and pediatric patients aged 7 and older.
- It simplifies treatment for narcolepsy, a chronic neurological disorder affecting sleep-wake cycles.
5. **Warnings and Common Side Effects**:
– The FDA has issued a boxed warning for LUMRYZ, highlighting risks such as mental health issues and sleepwalking.
– Common side effects include nausea, dizziness, bedwetting, headache, and vomiting in adults, and decreased weight, appetite, and sleepwalking in children.
6. **About Avadel pharmaceuticals**:
- Avadel Pharmaceuticals is a biopharmaceutical company focused on improving patient outcomes through innovative treatments.
– LUMRYZ represents a notable milestone for the company in addressing narcolepsy.
### Conclusion:
LUMRYZ offers a new era in narcolepsy treatment, providing a more convenient and potentially safer option for patients. However, it comes with important warnings and precautions that both patients and healthcare providers must be aware of to ensure safe use.
For more information, visit [www.LUMRYZREMS.com](http://www.LUMRYZREMS.com) or call 1-877-453-1029.
