�Eli Lilly and Co (NYSE:
LLY) and Boehringer Ingelheim receive 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 phoebe clinical studies of GAD
-- four-spot 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 iV acute placebo-controlled
studies safety and efficaciousness were assessed. Duloxetine significantly
improved core anxiety symptoms (as deliberate 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 ability to do
everyday activities in work, home and in social situations.(5,6) In
addition, duloxetine significantly reduced the likeliness of get worse 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 vulgar side personal effects in these studies included nausea, fatigue, dry
mouth, drowsiness, irregularity, insomnia, reduced appetite,
hyperidrosis (excessive perspiration), decreased libido, vomiting,
ejaculation delay and erectile disfunction.
Although global prevalence is not presently known, more than club
million Europeans(8,9) and six million the great unwashed in Central and South America
ar estimated to suffer from GAD(10), which is characterised by inordinate
anxiety and worry most 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 favourable reception 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 process major depressive disorder and diabetic peripheral
neuropathic painful sensation. Duloxetine gained marketing authorisation for the
treatment of GAD in Mexico in 2006 and in the United States in 2007.
About Generalised Anxiety Disorder
Approximately nine billion Europeans(8,9) and six million people in
Central and South America are estimated to hurt from GAD.(10) Quality of
life is affected, as symptoms of GAD tin include overdone 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, sleep disturbance and nausea.(11) The sickness
tends to be continuing with periods of exacerbation and remitment. Patients
report that episodes of generalised anxiety disorder are often brought on,
or worsened, by nerve-racking life events.(13)
About Duloxetine
While duloxetine's mechanism of activity in world is not fully known, it
is believed to affect both serotonin- and
ntinence is marketed by Lilly under
the steel 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 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 intervention 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 upset 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.
