European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder
INDIANAPOLIS, June 27 /PRNewswire-FirstCall/ -- Eli Lilly and Co (NYSE:
LLY) and Boehringer Ingelheim today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA) has issued a positive opinion supporting the approval of Cymbalta(R)
(duloxetine hydrochloride) for the treatment of Generalised Anxiety
Disorder (GAD).
The positive opinion is based upon the results of five clinical studies
-- four double-blind placebo-controlled studies and a relapse prevention
study -- involving more than 2,000 non-depressed adults with GAD. In each
of the four 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 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, 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) Difficult to detect, due to the fact
that the condition presents with a variety of symptoms,(11) GAD is
characterised by more than simple anxiety. The disorder is diagnosed when
patients suffer from 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.(12)
"If left untreated, symptoms of Generalised Anxiety Disorder may
progress to prevent patients from working and operating in daily social
situations," said Dr. Christer Allgulander of the Department of Clinical
Neuroscience, Karolinska Institutet in Stockholm. "According to population
and primary care surveys the majority of people suffering from anxiety, and
their physicians, still have unmet needs. This positive opinion on
duloxetine creates another effective pharmacotherapy option that will help
patients feel better, and help physicians in their aim to improve
functioning for those suffering from this debilitating condition."
Duloxetine, a member of a class of drugs commonly referred to as
serotonin and noradrenaline reuptake inhibitors,(13) is already approved 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.(12) The illness
tends to be chronic with periods of exacerbation and remission. Patients
report that episodes of generalized anxiety disorder are often brought on,
or worsened, by stressful life events.(14)
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
its effect on pain perception is due to increasing 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 is approved in some
countries for the treatment of stress urinary incontinence, Major
Depressive Disorder and Generalized 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.co.uk.
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)
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 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.ht
m. Accessed on 2.4.08
(11) Gliatto, M.F. Generalised Anxiety Disorder. American Family
Physicians, Vol. 62/No. 7, October 1, 2000.
(12) 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
(13) 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.
(14) Patient.co.uk. Generalized anxiety disorder. Available at
http://www.patient.co.uk/showdoc/27000122/. Accessed on 2.5.08
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
