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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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      "text": "The trials indicate a troubling QTc prolongation signal as well as fatalities.",
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      "text": "HAROSA 1 publication - excerpt\nPitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP\nA Randomized Trial\nRESEARCH QUESTION: Is pitolisant effective and safe for reducing daytime sleepiness in individuals with moderate to severe OSA adhering to CPAP treatment but experiencing residual EDS?\nSTUDY DESIGN AND METHODS: In a multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was titrated individually at up to 20 mg/day and taken over 12 weeks. The primary end point was change in the Epworth Sleepiness Scale (ESS) score in the intention-to-treat population. Key secondary end points were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, Clinical Global Impressions scale of severity, the patient’s global opinion, EuroQoL quality-of-life questionnaire score, Pichot fatigue questionnaire score, and safety.\nRESULTS: Two hundred forty-four OSA participants (82.8% men; mean age, 53.1 years; mean Apnea Hypopnea Index with CPAP, 4.2/h; baseline ESS score, 14.7) were randomized to pitolisant (n = 183) or placebo (n = 61). ESS significantly decreased with pitolisant compared with placebo (-2.6; 95% CI, -3.9 to -1.4; P < .001), and the rate of responders to",
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      "text": "Source: https://journal.chestnet.org/action/showPdf?pii=S0012-3692%2820%2935105-9",
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      "text": "Despite Bioprojet’s failure to show cardiovascular data in its narcolepsy trials, we uncovered worrisome QTc data in two pitolisant trials for a different indication – the only trials where we could locate a few crumbs. The trails were named HAROSA 1 and HAROSA 2, both for excessive daytime sleepiness in patients with obstructive sleep apnea (OSA). Neither trial appears to have been submitted to or reviewed by the FDA or EMA as part of their pitolisant approvals. The trials indicate a troubling QTc prolongation signal as well as fatalities. We emphasize that this is in spite of 1) using only a 20 mg dose – half the max dose on the pitolisant label; and 2) once again excluding patients with cardiovascular issues – indicating the significant real-world danger when the dose is doubled and patients are not cherry-picked. We begin with HAROSA 1, which was conducted from 2011 to 2014.",
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