Cymbalta Receives European Approval For The Treatment Of Generalised Anxiety Disorder

�Eli Lilly and Co (NYSE:
LLY) and Boehringer Ingelheim experience announced that the European Commission
has approved the use of Cymbalta(R) (duloxetine) for the treatment of
Generalised Anxiety Disorder (GAD). This blessing -- 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-spot clinical studies of GAD
-- iV double-blind short-run (acute) placebo-controlled studies and a
placebo-controlled relapse bar study -- involving more than 2,000
non-depressed adults with GAD. In each of the four-spot acute placebo-controlled
studies safety and efficaciousness were assessed. Duloxetine significantly
improved core anxiety symptoms (as metrical 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 operation, including power to perform
everyday activities in act, home and in social situations.(5,6) In
addition, duloxetine significantly decreased the likelihood of relapse in
those patients world Health Organization 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, fatigue, dry
mouth, drowsiness, irregularity, insomnia, reduced appetite,
hyperidrosis (excessive sudation), decreased libido, vomiting,
ejaculation delay and erectile dysfunction.



Although worldwide prevalence is not presently known, more than 9
million Europeans(8,9) and sestet million people in Central and South America
ar estimated to suffer from GAD(10), which is characterised by undue
anxiety and worry about a number of events and activities (such as
performance at work or school) over a free burning period of at least six
months.(11)



This regulatory blessing 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 socio-economic class 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 pain in the neck. 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 endure from GAD.(10) Quality of
life is affected, as symptoms of GAD can include overstated worry or
chronic anxiousness, irritability and poor concentration. Ability to work is
often compromised with the manifestation of physical symptoms such as
muscle tension, fatigue, rest disturbance and nausea.(11) The illness
tends to be chronic with periods of exacerbation and remit. Patients
write up that episodes of generalized anxiety disorder are much brought on,
or worsened, by trying life events.(13)

About Duloxetine



While duloxetine's mechanics of action in humanity is non fully known, it
is believed to affect both serotonin- and
ntinence is marketed by Lilly under
the brand 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
adult patients with generalized anxiety disorder: Examination from a
duloxetine, venlafaxine extended-release, and placebo-controlled report. 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 yearbook conference 2007. Boca Raton, Florida



(8) Lieb, R, et al. The epidemiology of generalised anxiety disorderliness 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:
hypertext transfer protocol://www.cureresearch.