New Treatment For Generalized Anxiety Disorder Approved By Health Canada

Main Category: Anxiety / Stress
Also Included In: Mental Health;  Regulatory Affairs / Drug Approvals;  Psychology / Psychiatry
Article Date: 17 Mar 2009 - 4:00 PDT

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Health Canada has approved Cymbalta® (duloxetine HCl) for the symptomatic relief of anxiety causing clinically significant distress in patients with generalized anxiety disorder (GAD), Eli Lilly Canada Inc. and Boehringer Ingelheim (Canada) Ltd. announced today.

The approval is based on the results of five randomized, double-blind, placebo-controlled studies in which the safety and efficacy of duloxetine in the treatment of GAD were studied in more than 2,700 non-depressed adults. In all studies, duloxetine significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), compared with placebo.[i],[ii],[iii],[iv],[v] Pooled data from three of the trials indicated that over the short term, Cymbalta (duloxetine HCl) improved core anxiety symptoms by 45 per cent compared to 32 per cent for those who took placebo.[vi] In a 26 week relapse prevention study, duloxetine-treated patients relapsed significantly less frequently (13.7 per cent) than placebo-treated patients (41.8 per cent).2

In addition, duloxetine patients reported greater improvement in functional impairment associated with the illness, including improved ability to perform everyday activities at work, home, and in social situations.1,2,3,4,5

The most common side effects in these studies included nausea, dizziness, dry mouth, fatigue, constipation, somnolence, and increased sweating. 1,2,3,4,5

About Generalized Anxiety Disorder

The one-year prevalence of GAD in the general population is about 1 per cent to 3 per cent, and the lifetime prevalence is about 6 per cent.[vii] While anxiety is a symptom of many mental health disorders, including depression, GAD is more than simple anxiety. The essential feature of the disorder is excessive anxiety and worry about a number of events and activities (such as work or school performance), occurring for a majority of days for at least six months.[viii]

For many people, the first symptom of GAD is the discomfort they feel in their bodies, rather than the worrisome thoughts. Some of the physical feelings include:[ix]

- Physical feelings of anxiety (e.g., heart racing, sweating, stomach discomfort)
- Feeling fidgety, restless, or unable to sit still
- Feeling irritable, getting easily upset, snapping at people for minor reasons
- Sleep problems: this can include having a hard time falling asleep, waking up frequently during the night, or having a restless and unsatisfying sleep.

GAD can be difficult to diagnose, as patients present with a variety of symptoms, both anxious and physical.[x] It may have a negative impact on a person's quality of life[xi] and ability to work.[xii] Symptoms can include exaggerated worry or chronic anxiety and irritability, which can lead to poor concentration and procrastination, as well as physical symptoms such as muscle tension, fatigue and sleep disturbance. The onset of symptoms is usually gradual, although GAD can be precipitated by stressful life events.11 The illness also tends to be chronic with periods of exacerbation and remission.11

About Duloxetine

Cymbalta (duloxteine HCl) is a potent and balanced serotonin and norepinephrine reuptake inhibitor (SNRI), which targets two chemical messengers in the brain believed to play a role in mood and sensitivity to pain - serotonin and norepinephrine. While the mechanism of action of duloxetine in humans is not fully known, scientists believe its effect on pain perception and mood is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta (duloxetine HCl) is also indicated in Canada for the symptomatic relief of major depressive disorder (MDD) and for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN).

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.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs close to 700 people across the country.

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 39,800 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. Boehringer Ingelheim employs over 720 people across Canada. Its head office is located in Burlington, Ontario and also has a global R&D facility located in Laval, Quebec which specializes in virology.

References

[i] 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; 0: 1-8.

[ii] Davidson J, et al. Duloxetine treatment for relapse prevention in adults with generalized anxiety disorder: a 26-week, randomized, placebo-controlled, double-blind study. European Neuropsychopharmacol 2008; 18: 673-681.

[iii] 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 trial. Psychological Medicine 2009 Feb; 39(2): 267-76.

[iv] 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; 22:167-174.

[v] Koponen H, et al. Efficacy of Duloxetine for the Treatment of Generalized Anxiety Disorder: Implications for Primary Care Physicians. J Clin Psychiatry 2007; 9:100-107.

[vi] Allugander 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.

[vii] Clinical practice guidelines: Management of anxiety disorders. Can J Psychiatry. July 2006; 51 (Suppl. 2): 51S-55S.

[viii] American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, p 472.

[ix]Anxiety BC. What is generalized anxiety disorder. Accessed March 2, 2009.

[x] Gliatto, Michael, F. "Generalised Anxiety Disorder." American Family Physician, Vol. 62/No. 7, October 1, 2000.

[xi] Mendlowicz, Maura V. and Stein, Murray B. "Quality of Life in Individuals with Anxiety Disorders." American Journal of Psychiatry, Vol. 157/No. 5, May 2000, pp 669-682.

[xii] Henning ER, Turk C, Mennin D, et al. Impairment and quality of life in individuals with generalised anxiety disorder. Depression and Anxiety 2007;24(5):342-349.

Source
Boehringer Ingelheim

What is Anxiety?

For more information on what anxiety is and what to do about it, please see:
What is Anxiety? What Causes Anxiety? What To Do About It.