Pernix Therapeutics (PTX) Begins TREXIMET Distribution to Wholesalers

September 28, 2016 4:04 PM EDT

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Pernix Therapeutics Holdings, Inc. (Nasdaq: PTX) announced the distribution of TREXIMET (sumatriptan and naproxen sodium) 10/60 mg to wholesalers has begun. TREXIMET 10/60 mg is indicated for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.¹ TREXIMET received U.S. Food and Drug Administration (FDA) approval for use in the pediatric population 12 years of age and older in May 2015; however, this formulation just recently became available due to manufacturing delays. The Company expects to begin focused product promotion activities in early Q4 2016.

“We are pleased to make TREXIMET available for pediatric patients,” said John Sedor, Chairman and CEO of Pernix Therapeutics. “Pediatric migraine sufferers have long represented an underserved patient population,” continued Mr. Sedor. “TREXIMET has the potential to address a significant treatment void for pediatric patients.”

TREXIMET is the only approved combination prescription medicine containing sumatriptan and naproxen sodium for the treatment of acute migraine attacks in pediatric patients. In a study of 490 pediatric patients (ages 12-17), TREXIMET was well tolerated and more effective in providing pain freedom at 2 hours as compared to placebo.1,2

"There often remains a need for migraine treatment in adolescents. The availability of the FDA approved combination of sumatriptan-naproxen could prove to be very helpful for the pediatric population ages 12-17 with acute migraine with or without aura. The combination includes two powerful, proven anti-migraine medications with differing and complementary modes of action in a well-tolerated and safe single tablet for acute treatment of adolescent migraine," said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth.

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