You are here

FDA Requests Additional Safety Information on Trexima, Potential Migraine Treatment

CHAPEL HILL, NC and RESEARCH TRIANGLE PARK, NC, JUNE 9, 2006 -- POZEN Inc. (NASDAQ: POZN) and GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Trexima. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval. The FDA has determined that Trexima is effective as an acute treatment for migraine headaches. The Agency has requested additional safety information on Trexima, which may require new studies. POZEN and GSK intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps to gain full approval.

Trexima, the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology™ and naproxen sodium 500 mg in a single tablet, is the first product designed to treat multiple mechanisms of migraine: inflammation and vasodilation.

About Sumatriptan Succinate (Imitrex) Tablets
Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as highblood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About Naproxen Sodium
Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox, Anaprox DS, Naprelan, Aleve and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

Source: Pozen, Inc.

Recent Headlines

Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds
Understanding Neural Ensembles in Infralimbic Cortex May Lead To Improved Addiction Treatment
Vitamin E Found in Samples Around the Country
Study Links Them to Premature Death
Nag With Texting and a ‘Winners Circle’
How Serotonin and Fluoxetine Affect Microbiota Residing in the Gut