European CHMP Issues Positive Opinion On Cymbalta For The Treatment Of Generalised Anxiety Disorder

Eli Lilly and Co ( NYSE: LLY ) and Boehringer Ingelheim announced that Committee for Medicinal Products for Human Use ( CHMP ) of 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 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 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 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 isn't 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 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 Doctor Christer Allgulander of Department of Clinical Neuroscience, Karolinska Institutet in Stockholm. " According to population and primary care surveys majority of people suffering from anxiety, and their physicians, still have unmet needs. This positive opinion on duloxetine creates another effective pharmacotherapy option that'll 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 treatment of GAD in Mexico in 2006 and in the United States in 2007.

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 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 isn't fully known, it is believed to affect both serotonin and norepinephrine/noradrenaline mediated nerve signalling in brain and 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 activity of serotonin and norepinephrine in 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's 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 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.

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 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 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 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 partnership under the brand name Cymbalta, except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly markets product as Cymbalta and Boehringer Ingelheim markets product as Xeristar ( R ) . In 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 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 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 National Institute Economic Review, 194, 28 October 2005.

( 10 ) Calculated extrapolations of prevalence rates against 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 ) 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

Eli Lilly and Company http: //www. lilly. com

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Celebrex: helpful modern medicine.

uses of Celebrex

Celebrex is a nonsteroidal anti-inflammatory drug ( NSAID ) , specifically a COX-2 inhibitor, which relieves pain and swelling ( inflammation ) . It's used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by Celebrex helps you perform more of your normal daily activities. Celebrex is also used to decrease growths found in intestines ( colon polyps ) of persons with a family history of this condition.

Celebrex works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

how to use of Celebrex

Read Medication Guide provided by your pharmacist before we start using Celebrex and each time we get a refill. If we have any questions regarding information, consult your doctor or pharmacist.

Take by mouth, usually once or twice daily, or as directed by your doctor. To decrease chance of stomach upset, Celebrex is best taken with food. Dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for prescribed length of time ( see also Warning section ) .

Take Celebrex with a full glass of water ( 8 oz or 240 ml ) unless your doctor directs you otherwise. Don't lie down for 30 minutes after taking Celebrex.

In certain conditions ( e. g. , arthritis ) , it may take up to two weeks, taken regularly, before significant benefits of Celebrex take effect.

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side effects of Celebrex

See also Warning section.

Stomach upset or gas may occur while use Celebrex. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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Celebrex may rarely cause serious liver disease. If we notice any of following highly unlikely but very serious side effects, stop taking Celebrex and consult your doctor or pharmacist immediately:

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precautions of Celebrex

Before taking Celebrex, tell your doctor or pharmacist if we are allergic to it; or to sulfa drugs, aspirin, other NSAIDs ( e. g. , ibuprofen ) , other COX-2 inhibitors; or if you have any other allergies.

Celebrex shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if we have:

Before using Celebrex, tell your doctor or pharmacist your medical history, especially of:

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

Caution is advised when using Celebrex in elderly because they may be more sensitive to side effects of Celebrex, especially stomach bleeding and kidney effects.

Caution is advised when using Celebrex in children with a certain type of arthritis ( systemic onset juvenile rheumatoid arthritis ) because they may be at increased risk for a very serious bleeding/clotting problem ( disseminated intravascular coagulation ) . Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in fingers/toes.

Celebrex should be used only when clearly needed during the first 6 months of pregnancy. It shouldn't be used during the last 3 months of pregnancy. Discuss risks and benefits with your doctor.

Celebrex passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding isn't recommended while using Celebrex. Consult your doctor before breast-feeding.

interactions of Celebrex

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with them first.

Celebrex shouldn't be used with the following medication because very serious interactions may occur while use Celebrex:

If you are currently using medication listed above, tell your doctor or pharmacist before starting Celebrex.

Before using Celebrex, tell your doctor or pharmacist of all prescription and nonprescription products we may use, especially of:

Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs ( NSAIDs such as aspirin, Celebrex, ibuprofen ) . These drugs are similar to Celebrex, so taking one of these drugs while also taking Celebrex may increase your risk of side effects. However, if your doctor has prescribed low doses of aspirin to prevent heart attack or stroke ( usually at dosages of 81-325 milligrams a day ) , we should continue to take aspirin. Daily use of NSAIDs ( e. g. , ibuprofen ) may decrease aspirin's ability to prevent heart attack/stroke. Consult your doctor or pharmacist for more details and to discuss other possible treatments ( e. g. , acetaminophen ) for your pain/fever.

This document doesn't contain all possible interactions. Therefore, before using Celebrex, tell your doctor or pharmacist of all the products we use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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