FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For period ending April 16, 2008
GlaxoSmithKline plc
(Name of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address of principal executive offices)
Indicate by check mark whether the registrant files or
will file annual reports under cover Form 20-F
or Form 40-F
Form 20-F x Form 40-F
--
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes No x
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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 today
that the FDA has approved Treximet for the acute treatment of migraine attacks
with or without aura in adults. Treximet is the first and only migraine product
designed to target multiple mechanisms of migraine by combining a triptan, a
class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory
pain reliever in a single tablet.
Treximet contains 85 mg sumatriptan, formulated with RT TechnologyTM, and 500 mg
naproxen sodium. Sumatriptan is the active ingredient in Imitrex(R) Tablets,
available in 25 mg, 50 mg and 100 mg strengths. In clinical trials, Treximet
provided a significantly greater percentage of patients migraine pain relief at
two hours compared to sumatriptan 85 mg 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.
"Migraine patients want their medicine to work early, and to continue to provide
relief," said Dr. Stephen Silberstein, professor of neurology and director of
the Jefferson Headache Center at Thomas Jefferson University and an investigator
who participated in clinical trials. "The FDA approval of Treximet is good news
for migraine patients because clinical trials showed that Treximet produced
sustained migraine pain relief for a significant number of patients." Further,
Silberstein said, significantly fewer patients on Treximet required the use of a
rescue medication to treat their migraine attack than those taking sumatriptan
85 mg.
Treximet is well studied, with more than 3,700 migraine sufferers treating
nearly 30,000 migraine attacks in clinical studies. The product is expected to
be 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 than
2,900 migraine sufferers.
Findings from these pivotal studies demonstrated that Treximet provided more
patients migraine pain relief at two and four hours compared to sumatriptan 85
mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies,
Treximet was effective at relieving the pain of a migraine attack and
maintaining that relief from two to 24 hours. In addition, Treximet effectively
relieved migraine associated symptoms - nausea and sensitivity to light and
sound - compared to placebo.
Treximet was generally well-tolerated in these pivotal studies The most common
treatment-related adverse events reported within 24 hours of taking Treximet
were 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 study
of 565 patients who treated nearly 24,500 migraine attacks with the active drug.
Patients completing the one-year study treated an average of five migraine
attacks per month with Treximet.
Migraines Impact Millions of Americans
Migraine headaches continue to be a significant problem for the estimated 29.5
million Americans, nearly half of which are undiagnosed. According to the
International Headache Society's diagnostic criteria, migraine is characterized
by 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 routine
activity, 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 that
migraine is much more complex, involving a chain of events that are both
neurovascular and inflammatory. Treximet contains sumatriptan that mediates
vasoconstriction, which correlates with the relief of migraine headache. It also
contains naproxen, an anti-inflammatory agent. Therefore, sumatriptan and
naproxen sodium contribute to the relief of migraine through pharmacologically
different 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 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.
For complete Prescribing Information please visit www.gsk.com.
About GlaxoSmithKline (LSE & NYSE: GSK)
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For detailed company
information, see GlaxoSmithKline's website: www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK's operations are
described under 'Risk Factors' in the 'Business Review' in the company's Annual
Report on Form 20-F for 2007.
About POZEN (NASDAQ: POZN)
POZEN is a pharmaceutical company committed to developing therapeutic
advancements for diseases with unmet medical needs where it can improve
efficacy, safety, and/or patient convenience. Since its inception, POZEN has
focused its efforts primarily on the development of pharmaceutical products for
the treatment of acute and chronic pain, migraine and other pain related
conditions. POZEN is also exploring the development of product candidates in
other pain-related therapeutic areas. POZEN has a development and
commercialization alliance with GlaxoSmithKline. The company's common stock is
traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company
information, including copies of this and other press releases, see POZEN's
website: 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" provisions
of the Private Securities Litigation Reform Act of 1995. You should be aware
that our actual results could differ materially from those contained in the
forward-looking statements, which are based on management's current expectations
and are subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product candidates;
costs and delays in the development and/or FDA approval of our product
candidates, including as a result of the need to conduct additional studies, or
the failure to obtain such approval of our product candidates, including as a
result of changes in regulatory standards or the regulatory environment during
the development period of any of our product candidates; our inability to know
with certainty what standards the FDA will use to evaluate drug candidates and
how that may change or evolve over time; uncertainties in clinical trial
results or the timing of such trials, resulting in, among other things, an
extension in the period over which we recognize deferred revenue or our failure
to achieve milestones that would have provided us with revenue; the receipt of
future development, regulatory or sales milestones and royalty payments from our
collaboration partners; our inability to maintain or enter into, and the risks
resulting from our dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization, marketing, sales
and distribution of any products; competitive factors; our inability to protect
our patents or proprietary rights and obtain necessary rights to third party
patents and intellectual property to operate our business; our inability to
operate our business without infringing the patents and proprietary rights of
others; general economic conditions; the failure of any products to gain market
acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry practice; and
one-time events, including those discussed herein and in our Annual Report on
Form 10-K for the period ended December 31, 2007. We do not intend to update any
of these factors or to publicly announce the results of any revisions to these
forward-looking statements.
Simon Bicknell
Company Secretary
15th April 2008
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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 1030
Director, Investor Relations Fran Barsky (919) 913 1044
POZEN Inc. Media Enquiries:
Pure Communications Sheryl Seapy (949) 608 0841
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorised.
GlaxoSmithKline plc
(Registrant)
Date: April 16, 2008 By: VICTORIA WHYTE
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Victoria Whyte
Authorised Signatory for and on
behalf of GlaxoSmithKline plc