Pernix announces closing delayed of Treximet acquisition from GSK

The company is working with GlaxoSmithKline to ensure sufficient supply to meet anticipated demand. The company and its lenders are also performing additional due diligence related to this supply issue.

Doug Drysdale, Chairman, President and CEO of Pernix said, "We are working with our lenders to complete our review and remain optimistic about our ability to close the acquisition of Treximet. We hope to complete our due diligence and the financing necessary in the near future."

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.