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  "documentTitle": "Harmony Biosciences (HRMY)",
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      "text": "In other words, only 12% of narcoleptics have cataplexy.",
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      "text": "Prevalence of narcolepsy and other sleep disorders and frequency of diagnostic tests from 2013–2016 in insured patients actively seeking care\nPrevalence and incidence of narcolepsy in a US health care claims database, 2008-2010",
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      "text": "Epidemiological studies on prevalence of narcolepsy (39 to 43 per 100K patients, per first study, 2020) and narcolepsy with cataplexy (4.87 per 100K, per second study, 2019)",
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      "text": "INDICATIONS AND USAGE\nWAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (1)",
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      "text": "Ex-territory managers and those in a field reimbursement role described a vast off-label prescribing scheme as key to Harmony’s sales. The Wakix label is clear and specific, stating as follows for “INDICATIONS AND USAGE”: “WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.” Patients must have narcolepsy, and if so, Wakix may be prescribed for 1) EDS and/or 2) cataplexy. However, narcolepsy is extremely rare, and narcolepsy with cataplexy is a small fraction of that number. A recent epidemiological study estimated the incidence of narcolepsy at ~40 per 100,000 or ~130K in the US (0.04%); another pegged narcolepsy with cataplexy at 4.87 per 100,000 (.005%), or 16K – in other words, only 12% of narcoleptics have cataplexy.",
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      "text": "WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (1) — Wakix label",
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      "text": "Source: https://jcsm.aasm.org/doi/10.5664/jcsm.8482; https://pubmed.ncbi.nlm.nih.gov/31004158/",
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