The review evaluated all high-sodium oxybates, fixed-dose, and twice-nightly administrations in both oxybate-experienced patients and those who had not undergone prior treatment.
During the second quarter, Jazz Pharmaceuticals registered a 39% year-over-year growth in net product sales of its low-sodium Xywav.
Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The phase 3 registrational INTUNE study will evaluate the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia.
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The program will provide researchers with the opportunity to request and analyze high-quality data and enable individuals with primary central disorders of hypersomnolence to share their data.
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The company also announced plans to begin a search for a new CEO to succeed Richard W. Pascoe, who will retire on June 1.
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Jazz Pharmaceutics says the benefits of reducing sodium intake resonate with prescribers as the large majority of new-to-oxybate narcolepsy patients continue to be prescribed Xywav.
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The phase 1 clinical trial is expected to provide additional information regarding the optimal dosing regimen.
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The company reported business updates for the quarter ending March 31, noting continued momentum in its commercial business for Wakix, as well as in the advancement of its clinical development programs for pitolisant for the treatment of idiopathic hypersomnia.
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Harmony Biosciences announced an accelerated timeline for completing its phase 3 study evaluating pitolisant in adults idiopathic hypersomnia.
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Zevra says data from its clinical program for its drug candidate to treat idiopathic hypersomnia will aid the development of treatments for rare sleep disorders through the platform.
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Harmony Biosciences spelled out next steps in its pursuit of pediatric exclusivity for WAKIX.
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The company says the name change, a nod to the rare disease community, signifies its commitment to developing treatments for people with rare conditions, including idiopathic hypersomnia.
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‘Support from sponsors like KemPharm are key to our efforts to advocate for and support those dealing with debilitating sleep disorders.’
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KemPharm expects to enroll about 48 adult patients with IH in more than 30 centers in the United States.
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The drug developer expects to initiate a phase 2 clinical trial in patients with idiopathic hypersomnia before year-end 2022 and a second trial in patients with narcolepsy in 2023.
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Jazz Pharmaceuticals has acquired development and commercialization rights in the United States for Sumitomo’s investigational DSP-0187.
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Harmony Biosciences has initiated a phase 3 trial evaluating the efficacy and safety of pitolisant in adults with idiopathic hypersomnia.
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