16th Apr 2008 07:00
GlaxoSmithKline PLC16 April 2008 Issued - Tuesday, 15 April 2008, London, UK - LSE Announcement TREXIMET(TM) (SUMATRIPTAN AND NAPROXEN SODIUM) TABLETS APPROVED BY FDA FOR ACUTE TREATMENT OF MIGRAINE Clinical studies show Treximet provided significantly more patients migraine pain relief compared to sumatriptan 85 mg GlaxoSmithKline (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) announced todaythat the FDA has approved Treximet for the acute treatment of migraine attackswith or without aura in adults. Treximet is the first and only migraine productdesigned to target multiple mechanisms of migraine by combining a triptan, aclass of migraine-specific medicines pioneered by GSK, and an anti-inflammatorypain reliever in a single tablet. Treximet contains 85 mg sumatriptan, formulated with RT TechnologyTM, and 500 mgnaproxen sodium. Sumatriptan is the active ingredient in Imitrex(R) Tablets,available in 25 mg, 50 mg and 100 mg strengths. In clinical trials, Treximetprovided a significantly greater percentage of patients migraine pain relief attwo hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. Inaddition, Treximet provided more patients sustained migraine pain relief fromtwo to 24 hours compared to the individual components. "Migraine patients want their medicine to work early, and to continue to providerelief," said Dr. Stephen Silberstein, professor of neurology and director ofthe Jefferson Headache Center at Thomas Jefferson University and an investigatorwho participated in clinical trials. "The FDA approval of Treximet is good newsfor migraine patients because clinical trials showed that Treximet producedsustained migraine pain relief for a significant number of patients." Further,Silberstein said, significantly fewer patients on Treximet required the use of arescue medication to treat their migraine attack than those taking sumatriptan85 mg. Treximet is well studied, with more than 3,700 migraine sufferers treatingnearly 30,000 migraine attacks in clinical studies. The product is expected tobe available in U.S. pharmacies by mid-May. Clinical Trials Demonstrated Superior Efficacy to Individual Components The approval of Treximet was based on data from two identical double-blind,randomized, placebo-controlled, parallel-group, multicenter studies of more than2,900 migraine sufferers. Findings from these pivotal studies demonstrated that Treximet provided morepatients migraine pain relief at two and four hours compared to sumatriptan 85mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies,Treximet was effective at relieving the pain of a migraine attack andmaintaining that relief from two to 24 hours. In addition, Treximet effectivelyrelieved migraine associated symptoms - nausea and sensitivity to light andsound - compared to placebo. Treximet was generally well-tolerated in these pivotal studies The most commontreatment-related adverse events reported within 24 hours of taking Treximetwere dizziness; nausea; somnolence; chest discomfort and chest pain; neck,throat and jaw pain, tightness and pressure; numbness/tingling; upset stomach;and dry mouth. Treximet was also studied in a one-year open-label tolerability and safety studyof 565 patients who treated nearly 24,500 migraine attacks with the active drug.Patients completing the one-year study treated an average of five migraineattacks per month with Treximet. Migraines Impact Millions of Americans Migraine headaches continue to be a significant problem for the estimated 29.5million Americans, nearly half of which are undiagnosed. According to theInternational Headache Society's diagnostic criteria, migraine is characterizedby recurrent headaches which, if untreated, typically last four to 72 hours,with symptoms including moderate to severe headache pain, throbbing head pain,head pain located on one side of the head, head pain aggravated by routineactivity, nausea, vomiting, and sensitivity to light and sound. In the past, many clinicians believed that migraine was a vascular condition,induced by blood vessel dilation alone. Today, new insight suggests thatmigraine is much more complex, involving a chain of events that are bothneurovascular and inflammatory. Treximet contains sumatriptan that mediatesvasoconstriction, which correlates with the relief of migraine headache. It alsocontains naproxen, an anti-inflammatory agent. Therefore, sumatriptan andnaproxen sodium contribute to the relief of migraine through pharmacologicallydifferent mechanisms of action. Important Safety Information About Treximet Prescription Treximet is indicated for the acute treatment of migraine attacks,with or without aura, in adults. Treximet should only be used where a cleardiagnosis of migraine headache has been established. Treximet may cause anincreased risk of serious cardiovascular thrombotic events, myocardialinfarction, and stroke, which can be fatal. This risk may increase withduration of use. Patients with cardiovascular disease or risk factors forcardiovascular disease may be at greater risk. Treximet contains a non-steroidalanti-inflammatory drug (NSAID). NSAID-containing products cause an increasedrisk of serious gastrointestinal adverse events including bleeding, ulceration,and perforation of the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms. Elderly patientsare at greater risk for serious gastrointestinal events. Treximet iscontraindicated in patients with history, symptoms, or signs of ischemiccardiac, cerebrovascular, or peripheral vascular syndromes and in patients withother significant underlying cardiovascular diseases. Treximet should not begiven to patients in whom unrecognized coronary artery disease is predicted bythe presence of risk factors without a prior cardiovascular evaluation. Treximetshould not be given to patients with uncontrolled hypertension because thecomponents have been shown to increase blood pressure. Concurrent administrationof MAO-A inhibitors or use of Treximet within two weeks of discontinuation ofMAO-A inhibitor therapy is contraindicated. Treximet and anyergotamine-containing or ergot-type medication (like dihydroergotamine andmthysergide) should not be used within 24 hours of each other. Since Treximetcontains sumatriptan, it should not be administered with another 5-HT1 agonist.Treximet is contraindicated in patients with hepatic impairment. Treximet iscontraindicated in patients who have had allergic reactions to productscontaining naproxen. It is also contraindicated in patients in whom aspirin orother NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasalpolyps. Both types of reactions have the potential of being fatal. Treximet iscontraindicated in patients with hypersensitivity to sumatriptan, naproxen, orany other component of the product. Cerebrovascular events have been reported inpatients treated with sumatriptan. In a number of cases, it appears possiblethat the cerebrovascular events were primary. It is important to advise patientsnot to administer Treximet if a headache being experienced is atypical. Thedevelopment of a potentially life-threatening serotonin syndrome may occur withtriptans, including treatment with Treximet, particularly during combined usewith selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrinereuptake inhibitors (SNRIs). NSAID-containing products, including Treximet,should be prescribed with extreme caution in those with a prior history of ulcerdisease or gastrointestinal bleeding. Treximet should not be used in latepregnancy because NSAID-containing products have been shown to cause prematureclosure of the ductus arteriosus. Treximet should not be used during earlypregnancy unless the potential benefit justifies the potential risk to thefetus. For complete Prescribing Information please visit www.gsk.com. About GlaxoSmithKline (LSE & NYSE: GSK) GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For detailed companyinformation, see GlaxoSmithKline's website: www.gsk.com. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, GSK cautions investors that any forward-looking statementsor projections made by GSK, including those made in this announcement, aresubject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect GSK's operations aredescribed under 'Risk Factors' in the 'Business Review' in the company's AnnualReport on Form 20-F for 2007. About POZEN (NASDAQ: POZN) POZEN is a pharmaceutical company committed to developing therapeuticadvancements for diseases with unmet medical needs where it can improveefficacy, safety, and/or patient convenience. Since its inception, POZEN hasfocused its efforts primarily on the development of pharmaceutical products forthe treatment of acute and chronic pain, migraine and other pain relatedconditions. POZEN is also exploring the development of product candidates inother pain-related therapeutic areas. POZEN has a development andcommercialization alliance with GlaxoSmithKline. The company's common stock istraded on The Nasdaq Stock Market under the symbol "POZN". For detailed companyinformation, including copies of this and other press releases, see POZEN'swebsite: www.pozen.com. Safe Harbor Statement Statements included in this press release that are not historical in nature are"forward-looking statements" within the meaning of the "safe harbor" provisionsof the Private Securities Litigation Reform Act of 1995. You should be awarethat our actual results could differ materially from those contained in theforward-looking statements, which are based on management's current expectationsand are subject to a number of risks and uncertainties, including, but notlimited to, our failure to successfully commercialize our product candidates;costs and delays in the development and/or FDA approval of our productcandidates, including as a result of the need to conduct additional studies, orthe failure to obtain such approval of our product candidates, including as aresult of changes in regulatory standards or the regulatory environment duringthe development period of any of our product candidates; our inability to knowwith certainty what standards the FDA will use to evaluate drug candidates andhow that may change or evolve over time; uncertainties in clinical trialresults or the timing of such trials, resulting in, among other things, anextension in the period over which we recognize deferred revenue or our failureto achieve milestones that would have provided us with revenue; the receipt offuture development, regulatory or sales milestones and royalty payments from ourcollaboration partners; our inability to maintain or enter into, and the risksresulting from our dependence upon, collaboration or contractual arrangementsnecessary for the development, manufacture, commercialization, marketing, salesand distribution of any products; competitive factors; our inability to protectour patents or proprietary rights and obtain necessary rights to third partypatents and intellectual property to operate our business; our inability tooperate our business without infringing the patents and proprietary rights ofothers; general economic conditions; the failure of any products to gain marketacceptance; our inability to obtain any additional required financing;technological changes; government regulation; changes in industry practice; andone-time events, including those discussed herein and in our Annual Report onForm 10-K for the period ended December 31, 2007. We do not intend to update anyof these factors or to publicly announce the results of any revisions to theseforward-looking statements. Simon Bicknell Company Secretary 15th April 2008 ### GlaxoSmithKline Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Joss Mathieson (020) 8047 5502 Gwenan White (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 US Analyst/Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 POZEN Inc. Investor Enquiries: Chief Financial Officer Bill Hodges (919) 913 1030Director, Investor Relations Fran Barsky (919) 913 1044 POZEN Inc. Media Enquiries: Pure Communications Sheryl Seapy (949) 608 0841 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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