Cymbalta Receives European Approval for the Treatment of Generalised Anxiety Disorder
August 22 2008 - 1:00AM
PR Newswire (US)
INDIANAPOLIS, Aug. 22 /PRNewswire-FirstCall/ -- Eli Lilly and Co
(NYSE: LLY) and Boehringer Ingelheim have announced that the
European Commission has approved the use of Cymbalta(R)
(duloxetine) for the treatment of Generalised Anxiety Disorder
(GAD). This approval -- the fourth for duloxetine in Europe -- was
issued on 28 July following an initial positive opinion issued by
the European Medicines Agency's (EMEA) Committee for Medicinal
Products for Human Use (CHMP) on 26 June 2008. The approval is
based upon the results of five clinical studies of GAD -- four
double-blind short-term (acute) placebo-controlled studies and a
placebo-controlled relapse prevention study -- involving more than
2,000 non-depressed adults with GAD. In each of the four acute
placebo-controlled studies safety and efficacy were assessed.
Duloxetine significantly improved core anxiety symptoms (as
measured by the Hamilton Anxiety Scale) compared with placebo (p
less than or equal to 0.001, p=0.02, p=0.007, p less than or equal
to 0.001 respectively)(1,2,3,4) and patients demonstrated
improvement in role functioning, including ability to perform
everyday activities in work, home and in social situations.(5,6) In
addition, duloxetine significantly decreased the likelihood of
relapse in those patients who initially responded to duloxetine and
were maintained on treatment for six months compared with those
switched to placebo.(7) The most common side effects in these
studies included nausea, fatigue, dry mouth, drowsiness,
constipation, insomnia, decreased appetite, hyperhidrosis
(excessive perspiration), decreased libido, vomiting, ejaculation
delay and erectile dysfunction. Although global prevalence is not
currently known, more than nine million Europeans(8,9) and six
million people in Central and South America are estimated to suffer
from GAD(10), which is characterised by excessive anxiety and worry
about a number of events and activities (such as performance at
work or school) over a sustained period of at least six months.(11)
This regulatory approval paves the way for launches in Europe and
applies to all 27 countries of the European Union, as well as
Norway, Iceland, and Liechtenstein. Cymbalta(R), a member of a
class of drugs commonly referred to as serotonin and noradrenaline
reuptake inhibitors,(12) is already approved by the EMEA to treat
major depressive disorder and diabetic peripheral neuropathic pain.
Duloxetine gained marketing authorisation for the treatment of GAD
in Mexico in 2006 and in the United States in 2007. Notes to
Editors: About Generalised Anxiety Disorder Approximately nine
million Europeans(8,9) and six million people in Central and South
America are estimated to suffer from GAD.(10) Quality of life is
affected, as symptoms of GAD can include exaggerated worry or
chronic anxiety, irritability and poor concentration. Ability to
work is often compromised with the manifestation of physical
symptoms such as muscle tension, fatigue, sleep disturbance and
nausea.(11) The illness tends to be chronic with periods of
exacerbation and remission. Patients report that episodes of
generalised anxiety disorder are often brought on, or worsened, by
stressful life events.(13) About Duloxetine While duloxetine's
mechanism of action in humans is not fully known, it is believed to
affect both serotonin- and norepinephrine/noradrenaline-mediated
nerve signalling in the brain and the spinal cord. Based on
pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine/noradrenaline. Scientists
believe that duloxetine's effects on mood and pain are due to an
increase in the activity of serotonin and norepinephrine in the
central nervous system. Duloxetine is approved for the treatment of
depression and diabetic peripheral neuropathic pain in many
countries and also approved in some countries for the treatment of
stress urinary incontinence, fibromyalgia, major depressive
disorder and generalised anxiety disorder. Duloxetine is approved
only for adults 18 and over. There is a possibility of an increased
risk of suicidal thoughts or behaviour in children and young adults
treated with antidepressants. Patients should call their doctor
right away if they experience worsening depression symptoms,
unusual changes in behaviour or thoughts of suicide, especially at
the beginning of treatment or after a change in dose. Patients
taking duloxetine may experience dizziness or fainting upon
standing. The most common side effects of duloxetine include: --
For depression: nausea, dry mouth, headache, insomnia, diarrhea --
For diabetic peripheral neuropathic pain: nausea, somnolence
(sleepiness), fatigue, headache, dizziness -- For stress urinary
incontinence: nausea, dry mouth, fatigue -- For generalised anxiety
disorder: nausea, fatigue, dry mouth, drowsiness, constipation,
insomnia, decreased appetite, hyperhidrosis, decreased libido,
vomiting, ejaculation delay and erectile dysfunction. (This is not
a complete list of side effects.) Duloxetine is contraindicated in
patients who are allergic to it, who have liver disease resulting
in hepatic impairment, who are taking a monoamine oxidase inhibitor
(MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe
kidney disease. The initiation of treatment with duloxetine also is
contraindicated in patients with uncontrolled hypertension that
could expose them to a potential risk of hypertensive crisis. Eli
Lilly and Company and Boehringer Ingelheim In November 2002, Eli
Lilly and Company and Boehringer Ingelheim signed a long-term
agreement to jointly develop and commercialize duloxetine
hydrochloride. This partnership covers neuroscience indications in
most countries outside of the United States and Japan, with few
exceptions. About Eli Lilly and Company Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
best-in-class pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly provides answers -- through medicines
and information -- for some of the world's most urgent medical
needs. Additional information about Lilly is available at
http://www.lilly.co.uk/ . About Boehringer Ingelheim The Boehringer
Ingelheim group is one of the world's 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and almost 38,900
employees. Since it was founded in 1885, the family-owned company
has been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and
veterinary medicine. In 2007, Boehringer Ingelheim posted net sales
of 10.9 billion euro while spending one fifth of net sales in its
largest business segment Prescription Medicines on research and
development. For more information please visit
http://www.boehringer-/ ingelheim.com Duloxetine for major
depressive episodes is marketed by Lilly and Boehringer Ingelheim
in all countries included in the partnership under the brand name
Cymbalta, except for Greece, Italy and Spain. In Greece, Italy and
Spain Lilly markets the product as Cymbalta and Boehringer
Ingelheim markets the product as Xeristar(R). In the United States,
Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine
will be co-developed and co-marketed by Lilly and Shionogi &
Co., Ltd. Duloxetine for stress urinary incontinence is marketed by
Lilly under the brand name Yentreve.(R) P-LLY 1 Koponen, H., et al.
Efficacy of Duloxetine for the Treatment of Generalized Anxiety
Disorder: Implications for Primary Care Physicians. Prim Care
Companion J Clin Psychiatry 2007: 9(2):100-107 2 Rynn M., et al.
Efficacy and Safety of Duloxetine in the Treatment of Generalized
Anxiety Disorder: A Flexible-Dose, Progressive-Titration,
Placebo-Controlled Trial. Depression and Anxiety 2007: 25(3):
182-189. 3 Hartford, J., et al. Duloxetine as an SNRI Treatment for
Generalized Anxiety Disorder: Results from a Placebo- and
Active-Controlled Trial. Int Clin Psychopharmacol 2007:
22(3):167-74. 4 Nicolini H, et al. Improvement of psychic and
somatic symptoms in adult patients with generalized anxiety
disorder: Examination from a duloxetine, venlafaxine
extended-release, and placebo-controlled study. In Press at
Psychological Medicine. 5 Endicott, J., et al. Duloxetine Treatment
for Role Functioning Improvement in Generalized Anxiety Disorder:
Three Independent Studies. The Journal of Clinical Psychiatry 2007:
68(4):518-24 6 Allgulander, C., et al. Pharmacotherapy of
Generalized Anxiety Disorder: Results of Duloxetine Treatment from
a Pooled Analysis of 3 Clinical Trials. Current Medical Research
and Opinion 2007: 23(6): 1245-1252 7 Davidson JRT, et al.
Duloxetine treatment for relapse prevention in adults with
generalized anxiety disorder: A 26-week randomized placebo-
controlled study. Poster presented at the American College of
Neuropsychopharmacology annual conference 2007. Boca Raton, Florida
8 Lieb, R, et al. The epidemiology of generalised anxiety disorder
in Europe. European Neuropsychopharmacology 2005 Aug;15(4):445-52.
9 National Institute of Economic and Social Research. Summarized
from the National Institute Economic Review,194, 28 October 2005.
10 Calculated extrapolations of prevalence rates against the
populations of a particular country or region, based upon
prevalence of generalized anxiety disorder in the US, UK, Canada or
Australia. Available at:
http://www.cureresearch.com/g/generalized_anxiety_disorder/stats-country.htm
. Accessed on 2.4.08 11 National Institute of Mental Health (NIMH).
Anxiety Disorders. Available at:
http://www.nimh.nih.gov/health/publications/anxiety-disorders/generalized-
anxiety-disorder-gad.shtml . Accessed on 2.5.08 12 Bymaster, FP et
al. The Dual Transporter Inhibitor Duloxetine: A Review of its
Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical
Results in Depression. Current Pharmaceutical Design. 2005; 11:
1475-1493. 13 Patient.co.uk. Generalized anxiety disorder.
Available at http://www.patient.co.uk/showdoc/27000122/ . Accessed
on 2.5.08 (Logo:
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http://www.newscom.com/cgi-bin/prnh/20070319/NYM004LOGO DATASOURCE:
Eli Lilly and Company CONTACT: Charles McAtee, Eli Lilly and
Company, +1-317-277-1566; or Eva Freitag, Boehringer Ingelheim, +
49 (6132) 77-2964
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