Cymbalta Receives European Approval For The Treatment Of Generalised Anxiety Disorder

�Eli Lilly and Co (NYSE:
LLY) and Boehringer Ingelheim cause announced that the European Commission
has approved the use of Cymbalta(R) (duloxetine) for the treatment of
Generalised Anxiety Disorder (GAD). This favorable reception -- the fourth for
duloxetine in Europe -- was issued on 28 July next an initial positive
view 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 fin clinical studies of GAD
-- quaternary double-blind short-term (acute) placebo-controlled studies and a
placebo-controlled relapse prevention study -- involving more than than 2,000
non-depressed adults with GAD. In each of the quaternary acute placebo-controlled
studies safety and efficacy were assessed. Duloxetine significantly
improved core anxiety symptoms (as calculated 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 lick, home and in social situations.(5,6) In
addition, duloxetine significantly decreased the likelihood of recidivate 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 personal effects in these studies included nausea, tiredness, dry
mouth, drowsiness, constipation, insomnia, reduced appetite,
hyperidrosis (excessive diaphoresis), decreased libido, vomiting,
ejaculation delay and erectile disfunction.



Although worldwide prevalence is not currently known, more than than ball club
million Europeans(8,9) and 6 million people in Central and South America
ar estimated to suffer from GAD(10), which is characterised by inordinate
anxiety and worry about a number of events and activities (such as
performance at work or school) all 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 division of drugs commonly referred to as
serotonin and noradrenaline re-uptake inhibitors,(12) is already approved by
the EMEA to care for major depressive disorder and diabetic peripheral
neuropathic botheration. Duloxetine gained marketing authorization for the
treatment of GAD in Mexico in 2006 and in the United States in 2007.

About Generalised Anxiety Disorder



Approximately nine 1000000 Europeans(8,9) and six meg people in
Central and South America are estimated to suffer from GAD.(10) Quality of
life is affected, as symptoms of GAD bum include exaggerated worry or
chronic anxiety, irritability and poor absorption. Ability to work is
often compromised with the manifestation of physical symptoms such as
muscle stress, fatigue, slumber disturbance and nausea.(11) The illness
tends to be chronic with periods of aggravation and remission. Patients
story that episodes of generalised anxiety disorder are ofttimes brought on,
or worsened, by nerve-wracking life events.(13)

About Duloxetine



While duloxetine's mechanism of action mechanism in humans is non fully known, it
is believed to affect both serotonin- and
ntinence is marketed by Lilly under
the make name Yentreve.(R)

References



(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
grownup 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 get worse prevention in
adults with generalized anxiety disorder: A 26-week randomised 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 generalized 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 special country or region, based upon prevalence of
generalised anxiety upset in the US, UK, Canada or Australia. Available
at:
hTTP://www.cureresearch.

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