FDA Agrees to Priority Review of Sumatriptan and Naproxen Sodium for Adolescent Patients


Sumatriptan and Naproxen SodiumOn January 15, 2015 Pernix Therapeutics excitedly announced an FDA acceptance for a priority review of Sumatriptan and Naproxen Sodium, also known as Treximet, for adolescent patients. Pernix expects an FDA approval by the second quarter of 2015, which would greatly benefit the adolescent patient population suffering from migraines. This anticipated approval would be specific to adolescents between the ages of 12 and 17, for the treatment of migraine headaches both with and without aura. Data from three comprehensive trials was given to the FDA, proving the efficacy, safety and tolerability of this formidable therapy. Currently there is no approved treatment for the adolescent population that includes Sumatriptan, either alone or in combination with another drug. The Sumatriptan/Naproxen Sodium combination is only approved for use in adults for the acute treatment of migraine headaches, with and without aura. The approval of Treximet for the adolescent population would grant a remedy to a patient population in need of novel treatments to combat debilitating migraines.

The incidence of migraines has become greater among both children and adolescents over the past decade. A startling 82 percent of children report having experienced a migraine-like headache by age 15, and 6 percent of American adolescents are documented to be suffering from migraines on a yearly basis. Migraine headaches can affect children and adolescents similarly to adults, and they can be just as disabling. However, studies have shown that the duration of migraines tends to be a bit shorter in adolescents as compared to their adult counterparts, with many young people experiencing a migraine attack lasting about an hour. The range of the disabling symptoms of a migraine headache have been between 1 and 72 hours for the majority of adolescents. Additionally, the adolescent patient population experiences mainly frontal or temporal pain, unlike adult sufferers who typically endure unilateral pain.

LGM Pharma can assist clients as a supplier/distributor of the APIs Sumatriptan and Naproxen Sodium for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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