MORRISTOWN, N.J.--(BUSINESS WIRE)--Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TREXIMET (sumatriptan / naproxen sodium) to seek approval for use in adolescent patients, age 12 – 17, for the acute treatment of migraine with or without aura.
Migraine has an estimated prevalence of 8% to 23% in children = 11 years of age.1 Treatments, both acute and prophylactic, are similar to those used in adults.2,3 Sumatriptan is the most widely studied triptan in adolescents.6,7 However, studies of sumatriptan alone failed to demonstrate efficacy versus placebo for the primary end points, chiefly due to high placebo response.7-13 In adults, TREXIMET, the combination of sumatriptan and naproxen sodium, has demonstrated superior efficacy, similar tolerability, and improved quality of life and medication satisfaction to its components.14-17
“The submission of this sNDA represents an important step forward in our efforts to provide adolescent patients with the rescue relief they need for this often debilitating condition.” said Doug Drysdale, Chairman, President and CEO. “Pernix Therapeutics is pleased to submit this filing on time, providing the potential to extend the exclusivity of TREXIMET an additional 180 days.”
To date, there is no sumatriptan or combination prescription medication for the treatment of acute migraine attacks with or without aura approved for use in this population. Presently, TREXIMET is approved in the U.S. for the acute treatment of migraine with or without aura in adults.
Three trials were conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of TREXIMET for the acute treatment of adolescent migraine. The regulatory submission incorporates data from each of these three studies:
•The pharmacokinetic (PK) study was designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at a lower dose in adolescent migraine patients. The same doses were also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters were compared between these two groups and between doses. The results showed that the drug disposition in adolescents is similar to adults.
• The adolescent efficacy study was an outpatient, double-blind, randomized, placebo-controlled, parallel group conducted at 77 US sites between December 2008 and January 2010. This study was published in PEDIATRICS, Volume 129, Number 6, June 2012. The results support the use of TREXIMET in adolescents for the acute treatment of pain and associated symptoms of migraine with or without aura.
•The long-term safety study of TREXIMET in adolescents, age 12-17, for the acute treatment of migraine showed that the safety profile is similar to that in adults.
About TREXIMET
TREXIMET was first approved by the U.S. Food and Drug Administration (FDA) in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. TREXIMET has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components. In clinical trials, TREXIMET provided a significantly greater percentage of patients with migraine pain relief at two hours compared to sumatriptan 85mg or naproxen sodium 500 mg alone. In addition, TREXIMET provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.
IMPORTANT SAFETY INFORMATION
Prescription TREXIMET is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET. TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache. TREXIMET should only be used where a clear diagnosis of migraine headache has been established. TREXIMET may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. TREXIMET contains a non-steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. TREXIMET is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. TREXIMET should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. TREXIMET should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure. Concurrent administration of MAO-A inhibitors or use of TREXIMET within two weeks of discontinuation of MAO-A inhibitor therapy is contraindicated. TREXIMET and any ergotamine-containing or ergot-type medication (like dihydroergotamine and mthysergide) should not be used within 24 hours of each other. Since TREXIMET contains sumatriptan, it should not be administered with another 5-HT1 agonist.
TREXIMET is contraindicated in patients with hepatic impairment. TREXIMET is contraindicated in patients who have had allergic reactions to products containing naproxen. It is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal. TREXIMET is contraindicated in patients with hypersensitivity to sumatriptan, naproxen, or any other component of the product. Cerebrovascular events have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary. It is important to advise patients not to administer TREXIMET if a headache being experienced is atypical. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with TREXIMET, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). NSAID-containing products, including TREXIMET, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. TREXIMET should not be used in late pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus. TREXIMET should not be used during early pregnancy unless the potential benefit justifies the potential risk to the fetus.
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and psychiatry, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its Pernix sales force, uses contracted sales organizations to market its non-core, cough and cold products, and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.
To learn more about Pernix Therapeutics, visit www.pernixtx.com.
REFERENCES
1. Lewis D, Ashwal S. Hershey A. Hirtz D, Yonker M. Silberstein S; American Academy of Neurology Quality Standards Subcommittee; Practice Committee of the Child Neurology Society. Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Neurology 2004;63(12) : 2215- 2224
2. Farkas V. Appropriate migraine therapy for children and adolescents. Cephalalgia. 1999;19(suppl 23):24-26, discussion 26—28
3. Termine C, Clzge A. Antonaci F, Natriashvili, S. Guidetti V. Wtiber-Bingtil C. Overview of diagnosis and management of paediatric headache. Part II: therapeutic management. J Headache Pain. 2011;12(1):25-34
4. Hamalainen ML, Hoppu K, Santavuori P. Sumatriptan for migraine attacks in children: a randomized placebo-controlled study. Do children with migraine respond to oral sumatriptan differently from adults? Neurology 1997;48(4) :1100--1103
5. Winner P. Prensky A. Linder S. DeBussy S. Asgharnejad M. Adolescent migraine: efficacy and safety of sumatriptan tablets . J Neural Sci. 1997;150(suppl) :S172
6. Winner P. Rothner AD. Saper J, et al. A randomized, double-blind, placebo-controlled study of sumatriptan nasal spray in the treatment of acute migraine in adolescents. Pediatrics. 2000;106(5):989-997
7. Winner P. Rothner AD. Wooten JD, Webster C. Ames M. Sumatriptan nasal spray in adolescent migraineurs: a randomized, doubleblind, placebo-controlled, acute study. Headache. 2006;46(2) :212-222
8. Lewis DW. Winner P. Hershey AD. Wasiewski WW; Adolescent Migraine Steering Committee. Efficacy of zolmitriptan nasal spray in adolescent migraine. Pediatrics. 2007; 120(2) :390--396
9. Winner P, Lewis D. Visser WH. Jiang K. Ahrens S. Evans JK; Rizatriptan Adolescent Study Group. Rizatriptan 5 mg for the acute treatment of migraine in adolescents: a randomized, double-blind, placebo-controlled study. Headache. 2002;42(1) :49-55
10. Darnen L. Bruijn JKJ. Verhagen AP. Berger MY. Passchier J. Koes BW. Symptomat ic treatment of migraine in children: a system atic review of medication trials. Pediatrics. 2005 ;116(2).
11. Evers S. Marziniak M. Frese A, Gralow I. Placebo efficacy in childhood and adolescence migraine: an analysis of double-blind and placeba-controlled studies. Cephalalgia.2009;29(4) :436—444
12. Lewis DW, Winner P, Wasiewski W. The placebo responder rate in children and adolescents. Headache. 2005;45(3) :232-239
13. Rothner AD. Wasiewski W. Winner P, Lewis D. Stankowski J. Zolmitriptan oral tablet in migraine treatment: high placebo responses in adolescents. Headache. 2006;46(1) :101-109
14. Brandes JL. Kudrow D. Stark SR. et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA 2007; 297(13):1443--1454
15. Winner P, Cady RK. Ruoff GE. et al. Twelvemonth tolerability and safety of sumatriptan naproxen sodium for the treatment of acute migraine. Mayo Clin Proc. 2007;82(1) :61-68
16. Landy S. DeRossett SE. Rapoport A. et al. Two double-bl ind. Multicenter, randomized, placebo-controlled , single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity,and satisfaction outcomes . MedGenMed. 2007 ;9(2) :53
17. Smith T. Blumenthal H, Diamond M. et al. Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life and satisfaction outcomes. Headache. 2007;47 (5) :683-692
Contacts
Pernix Therapeutics Holdings Inc.
Investor Relations
Sanjay Patel, 800-793-2145 ext. 1009
Chief Financial Officer
spatel@pernixtx.com
Doug Drysdale, 800-793-2145 ext. 1001
Chairman, President and Chief Executive Officer
ddrysdale@pernixtx.com
Media Relations
Marianne Lambertson, 800-793-2145 ext. 1012
Vice President, Marketing and Corporate Communications
mlambertson@pernixtx.com
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