$PTX news
MORRISTOWN, N.J. , Sept. 28, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics
Holdings, Inc. (NASDAQ
TX), a specialty pharmaceutical company with a focus on
Pain and CNS conditions, today 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 .
IndicationPrescription TREXIMET® is used to treat acute migraine headaches with or without aura in patients 12 years of age and older.
TREXIMET® is not used to treat other types of headaches such as hemiplegic or
basilar migraines. TREXIMET® is not used to prevent or decrease the number of
migraine headaches you have. It is not known if TREXIMET® is safe and effective
to treat cluster headaches.
MORRISTOWN, N.J. , Sept. 28, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics
Holdings, Inc. (NASDAQ
TX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, today 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 .
IndicationPrescription TREXIMET® is used to treat acute migraine headaches with or without aura in patients 12 years of age and older.
TREXIMET® is not used to treat other types of headaches such as hemiplegic or
basilar migraines. TREXIMET® is not used to prevent or decrease the number of
migraine headaches you have. It is not known if TREXIMET® is safe and effective
to treat cluster headaches.
2
