Patrick Daly

DocwireNews

Researchers, led by Anne Marie Morse, DO, evaluated the safety and efficacy of low-sodium oxybate (LXB) in patients with idiopathic hypersomnia who continued in the open-label extension (OLE) period of a phase 3, randomized clinical trial. In the main study&rsquo;s treatment period, LXB was shown to meaningfully improve symptoms of hypersomnia and quality-of-life and functioning measures.Dr. Morse and colleagues reported the safety and efficacy profiles of LXB improved or maintained during the 6-month OLE period, providing support for the use of LXB as an effective long-term treatment for <a href="https://docwirenews.com/post/investigating-ulotaront-for-rem-suppression-in-sleep-disorders">patients with idiopathic hypersomnia</a>. The study&rsquo;s findings were presented in the Journal of Clinical Sleep Medicine.<h3>Hypersomnia Improved Long-term With Low-Sodium Oxybate</h3>The <a href="https://clinicaltrials.gov/study/NCT03533114">primary end points</a> were Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Change, Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) scores and treatment-emergent adverse events (TEAEs).A total of 106 patients with a mean age of 41.0 &plusmn; 13.8 years (female, 71%; White, 83%) were included in the 6-month OLE period.According to the researchers, both mean ESS and IHSS total scores improved from baseline to week 2 and to the end of the treatment extension period:<table border="1">
<tbody>
<tr>
<td width="156"></td>
<td style="text-align: center;" width="156">Baseline</td>
<td style="text-align: center;" width="156">Week 2</td>
<td style="text-align: center;" width="156">End of extension</td>
</tr>
<tr>
<td width="156">Mean ESS score</td>
<td style="text-align: center;" width="156">16.3 &plusmn; 2.8</td>
<td style="text-align: center;" width="156">6.7 &plusmn; 4.7</td>
<td style="text-align: center;" width="156">5.3 &plusmn; 3.7</td>
</tr>
<tr>
<td width="156">Mean IHSS total score</td>
<td style="text-align: center;" width="156">32.6 &plusmn; 7.3</td>
<td style="text-align: center;" width="156">16.2 &plusmn; 8.9</td>
<td style="text-align: center;" width="156">14.8 &plusmn; 8.6</td>
</tr>
</tbody>
</table>The median paired differences from week 2 to end of extension were &minus;1.0 (range, &minus;20 to 7; nominal P=.012) for ESS and &minus;1.0 (range, &minus;31 to 19; nominal P=.086).The proportion of patients who reported a rating of &ldquo;very much improved&rdquo; increased from 36.7% at week 2 to 53.8% after the extension period ended. Additionally, authors noted FOSQ-10 and WPAI:SHP outcomes did not change and the incidence of newly reported TEAEs decreased during the treatment extension period.&ldquo;Efficacy and safety of LXB were maintained or improved during the 6-month OLE,&rdquo; Dr. Morse summarized, &ldquo;supporting long-term treatment with LXB in adults with idiopathic hypersomnia.&rdquo;Read More Recent News on <a href="https://www.docwirenews.com/page/sleep-disorders">Sleep Disorders</a> or <a href="https://www.docwirenews.com/page/neurology">Neurology</a>

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Latest News

Low-Sodium Oxybate Improves Excessive Sleepiness Long-term

Sleep Disorders

Low-sodium oxybate showed a sustained reduction of hypersomnia symptoms during the 6-month extension of a phase 3 study. 

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