SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
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41 Migraine Market Product Summary • Treximet ® is a fixed dose combination of sumatriptan and naproxen • Indicated for acute treatment of migraine attacks with or without aura in patients older than 12 years of age • Approved and launched by GlaxoSmithKline ( “ GSK ” ) in 2008 • Acquired by Pernix in August 2014 ; re - launched in September 2014 • Clinically differentiated combination therapy • RT Technology ( 3 ) formulation • Fixed dose combination of sumatriptan / naproxen • Bi - layer tablet with dual mechanism of action • Primary patents expired February 14 , 2018 (includes 6 month pediatric exclusivity extension) with additional patent protection through April 2026 • Post LOE, three generic competitors entered the market. Concurrent with their entry, Pernix launched an AG version of Treximet ® and continues to distribute the branded version • Migraines consist of a characteristic headache (e.g. unilateral, severe throbbing lasting 4 - 72 hours) and is often accompanied by nausea or vomiting and sensitivity to both light and sound • An estimated 26M people suffer from migraines in the U.S. • ~13% of the population could be considered candidates for prescription therapy • Treatment for moderate to severe migraine headaches include triptans, NSAIDs, ergot medication, caffeine - based products and other pain - relief options • Triptans are considered first - line therapy for migraines and are reserved for patients with persistent headaches despite treatment with traditional NSAIDs • Treximet ® is a fixed dose combination of sumatriptan and naproxen with RT Technology, a rapid release technology; it is the only combination sumatriptan and naproxen sodium product for acute migraine attacks • Sumatriptan works by constricting blood vessels and blocking pain signals from nerves, while naproxen reduces inflammation of the meninges • Treximet ® provides superior pain relief both at 2 hours and 24 hours vs. individual components (1)(2) (1) Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan - naproxen for acute treatment of migraine: randomized trial. JAMA 2007; 297(13): 1443 - 1554. (2) Smith TR, Sunshine A, Stark SR, et al. Sumatriptan and naproxen sodium for the acute treatment of migraine.Headache2005; 45:983 - 991S. (3) RT Technology™ is a rapid release technology used in making TREXIMET® tablets. This technology enables the tablets to rapidly break apart into small pieces and disperse in the stomach. Treximet ® Overview