New Real-World Study Reveals Risks of Accidental Dosing Errors with Twice-Nightly Oxybates

Avadel Pharmaceuticals plc, a biopharmaceutical company focused on improving treatments to improve lives, recently unveiled real-world data showing the risk of accidental dosing errors with immediate-release twice-nightly oxybate. This groundbreaking research was published in Drugs — Real World Outcomes and is now available to the public. Titled “Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data From the US Food and Drug Administration Adverse Event Reporting System,” this study is sure to revolutionize the way we think about oxybate dosing.

Patients with narcolepsy face the challenge of uneven and interrupted sleep – a difficult dilemma made even harder by the twice-nightly formulation of Oxybates. To assess potential dosing errors, an analysis was conducted on post-marketing safety surveillance data from the FDA Adverse Event Reporting System. The results revealed an alarming risk of accidental mistakes and highlighted the importance of understanding dosing instructions to ensure safe and effective treatment.

Of the 541 reports regarding potential improper use of an immediate-release oxybate taken twice-nightly, a significant 177 of them were submitted as serious reports and underwent further analysis.

Forty-one participants experienced adverse events after an accidental early administration of the second dose of a medication. This unexpected result has raised concerns about the safety of this particular medication.

Nine cases of near misses were reported with no harm done, after early dosing. Thankfully, the situation was resolved with no consequences and no one was harmed. It was a close call, but thankfully the correct steps were taken to mitigate the risk.

Do you ever wonder what would happen if you took a second dose of medication early? We recently conducted a study to investigate this very question, surveying 25 individuals who had intentionally taken a second dose early. Our results were intriguing, and we can’t wait to share them with you!

102 people have been found to be misusing their medication, whether it be through late dosing or not taking it every day. This inappropriate use of medication is not only detrimental to their health, but it can also have long-lasting consequences. It is important to be aware of the correct way to take medication, as well as the implications of not doing so.

Among the 41 reports of taking the second dose too early, a number of adverse events were experienced. These included fever, fatigue, headaches, body aches and even rashes in some cases. It is clear that taking the second dose too early can have serious consequences, so it is important to adhere to the recommended schedule.

Almost a quarter of all cases reported required the use of emergency services, with 27% of these cases requiring hospitalization. This highlights the severity of the issue and the importance of taking the necessary precautions to protect oneself.

Reports of adverse events related to accidentally taking the second dose of a medication too soon have included a range of disturbing symptoms, such as CNS depression, bradycardia, respiratory depression, dizziness, seizures, confusion, delirium, difficulty rousing oneself, drowsiness, falls, nausea, vomiting and enuresis. These symptoms can be both alarming and uncomfortable, and should be taken seriously.

One fifth of accidental early administration cases experienced an unusual situation where they consumed their two doses of immediate-release sodium oxybate oral solution almost at the exact same time. Of the remaining cases, 39% took their second dose less than an hour after the first one, while the remaining 61% waited between one and two and a half hours.

Patients who took their second dose of medication within an hour of their first dose were more likely to experience adverse effects than those who waited longer between doses. This finding highlights the importance of following dosing instructions carefully to help reduce the risk of harm to patients.

The potential risk of harm to patients from consuming the second dose of immediate-release twice-nightly oxybate products less than 2.5 hours after the first dose is unknown. There is no information on this matter in the product labeling. As such, caution should be exercised when taking these medications.

The potential risks associated with immediate-release sodium oxybate are not widely known, yet a recent analysis of post-marketing adverse event reports reveals that one-fourth of reported cases resulted in emergency medical services, and an additional 27% required hospitalization due to patients accidentally consuming their second, middle-of-the-night dose less than two and a half hours after the first dose. These reports are only the ‘tip of the iceberg’ as reporting is voluntary for patients and clinicians, and likely underestimates the incidence. Avadel’s Senior Vice President for Medical and Clinical Affairs, Jennifer Gudeman, PharmD., believes that an extended-release once-nightly sodium oxybate product that eliminates a second, middle-of-the-night dose could potentially mitigate these risks and help to raise awareness of the potential dangers associated with immediate-release oxybates.

About Avadel Pharmaceuticals plc

At Avadel Pharmaceuticals plc (Nasdaq: AVDL), we are dedicated to transforming lives through transforming medicines. Our cutting-edge approach involves developing innovative medications that address the issues faced by patients with existing treatment options. Our primary drug candidate is an investigational form of sodium oxybate that utilizes our exclusive drug delivery technology, which can be taken once a day at bedtime for the treatment of cataplexy or EDS in adults with narcolepsy. We strive to create solutions that can improve the lives of those affected by these conditions.

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