SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
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31 Insomnia / Sleep Maintenance Market Product Summary • Treats insomnia characterized by difficulties with sleep maintenance • Only non - controlled prescription sleep medication for people with trouble staying asleep • Acquired by Pernix in 2013 • Approved by the FDA in 2010 and re - launched in April 2014 • TRx reached all - time monthly high in October 2018 • Potential for Rx - to - OTC switch • Insomnia is characterized by: • Difficulty falling or staying asleep; OR • Early - morning awakenings without being able to return to sleep • As many as 70 – 80M people (23.6% of U.S. population) have chronic insomnia (1) • The insomnia market is largely dominated by GABA - receptor agonists, which are Schedule IV controlled substances • Branded therapies include Ambien ® (zolpidem)(Peak Brand Sales: $2.5B (2) ) and Lunesta ® ( eszopiclone )(Peak Brand Sales: $827M) (3) • Silenor ® is an FDA approved product used to treat insomnia characterized by difficulties with sleep maintenance • Pernix believes product profile could support an attractive OTC therapy (1) Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM - IV - TR; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition criteria: results from the America Insomnia Survey. Biol. Psychiatry. 2011;69:592 – 600. (2) Combined sales of Ambien and Ambien CR. (3) EvaluatePharma . Silenor ® Overview