�AstraZeneca announced new SEROQUEL XR� (protracted release quetiapine fumarate) clinical study information in patients with Generalised Anxiety Disorder (GAD), presented at the 21st European College of Neuropsychopharmacology (ECNP) Congress in Barcelona. In this study, extended handout quetiapine fumarate significantly improved symptoms of anxiety at Week 8 compared with placebo and this was observed as early as day 4. The active comparator branch, escitalopram 10mg/day, was as well effective at improving symptoms of GAD at week 8 compared with placebo although improvement was not observed at day 4.
During their lifetimes, it is estimated between 2.7% and 5.4% of people in Europe will suffer from GAD.1 Characteristic symptoms include chronic anxiety, enlarged worry and tension - it is often attended by depression or other anxiety disorders2,3 - and it has a substantial negative impact on Health-Related Quality of Life (HRQoL), productiveness at shape (including absenteeism) and healthcare costs1.
Antidepressants (SSRIs (selective-serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors)) are standard treatments that ar generally efficacious but or so 30 per centum of patients treated with SSRIs or SNRIs testament have an inadequate response4. Additionally, they may have got a comparatively slow attack of action, sometimes requiring combination with a myopic course of benzodiazepines (BZDs) to accomplish initial symptom control - however, BZDs may have the potential for dependence and detachment symptoms5.
The data presented today in Barcelona ar the results of Study 10 - conducted across 64 centres in the U.S. and part of the clinical development program for extended release quetiapine fumarate for the treatment of GAD6. A add together of 854 patients aged 18-65 with a DSM-IV3 diagnosis of GAD were randomized to receive either extended vent quetiapine fumarate 150mg/day (n=219), 300mg/day (n=207), escitalopram 10mg/day (n=213) or placebo (n=215). At workweek 8, prolonged release quetiapine fumarate 150mg/day, 300mg/day and escitalopram 10mg/day, significantly decreased mean Hamilton Anxiety Rating Scale (HAM-A) total stacks from randomization compared with placebo (13.9 [p
Both extended tone ending quetiapine fumarate and escitalopram were generally well tolerated. Among lengthened release quetiapine fumarate treated patients, untoward events with incidence greater than 10% and double that of placebo were dry mouth, somnolence, drugging and constipation; among escitalopram-treated patients they were sedation and sickness.
The incidence of AEs associated with EPS among patients treated with extended release quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo were 4.2%, 6.0%, 6.8% and 5.7% respectively; the incidence of AEs associated with sexual dysfunction were were 4.1%, 3.9%, 8.1% and 3.7% severally. The proportions of patients who experienced a clinically important budge in fast blood glucose (from normal to >126mg/dL) were 3.7%, 1.6%, 1.1% and 3.2% in the quetiapine fumarate 150mg/day, 300mg/day, escitalopram 10mg/day or placebo groups, severally; the proportions of patients experiencing >7% increase in weight were 3.8%, 3.9%, 0.5% and 0.9% respectively6.
About Generalized Anxiety Disorder (GAD)
GAD is characterized by chronic anxiety, magnified worry, and tension, even when thither is little or zippo to harass it. People with GAD anticipate disaster and are overly interested about health issues, money, family problems, or difficulties at work.2,3
People with GAD can't seem to get rid of their concerns, even though they usually realize that their anxiety is more intense than the place warrants. They can't relax, startle well, and have got difficulty concentrating. Often they have hassle falling asleep or staying asleep. Physical symptoms that often accompany the anxiety include fatigue, headaches, musculus tension, muscle aches, difficulty swallowing, quivering, twitching, excitability, sweating, nausea, lightheadedness, having to go to the bathroom oft, feeling out of breath, and hot flushes. GAD is diagnosed when somebody excessively worries about a number of everyday problems for at least 6 months2,3.
About SEROQUEL and SEROQUEL XR
In May 2008, SEROQUEL XR� (extended release quetiapine fumarate) became the first ever so antipsychotic to complete a clinical development programme and be filed with the FDA in the U.S. for commendation in the treatment of GAD7 - today it is not approved in any country for the treatment of GAD but remains under review with the FDA. SEROQUEL XR� is sanctioned in the US and 28 further countries for the treatment of schizophrenic disorder in grownup patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of frenzied episodes associated with bipolar disorder, and the handling of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking commendation for the treatment of Major Depressive Disorder in the US was as well announced in February. SEROQUEL XR is not approved for these indications at this clock time and the applications remain under review by the regulatory authorities.
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide*. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar manic disorder, and in 11 countries including the US for the discourse of bipolar depression. It was too recently sanctioned by the FDA in the USA for the for the maintenance treatment of patients with bipolar I upset, as adjunct to atomic number 3 or valproate - a similar submission has been made in Europe.
* Based on assumptions: (1) estimated turn of prescriptions per patient based upon IMS APLD data; and (2) IMS Prescription data for SEROQUEL covering 13 major markets in which this information is uncommitted since the time of launch.
About AstraZeneca
AstraZeneca is a major international healthcare stage business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and provider for health care services. AstraZeneca is one of the world's ahead pharmaceutical companies with health care sales of US $29.55 1000000000000 and is a leader in gI, cardiovascular, neuroscience, respiratory, oncology and infection product gross sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as substantially as the FTSE4Good Index.
http://www.astrazeneca.com
References
1 Wyrwich KW et al. A review of the humanistic and economic outcomes in European patients diagnosed with generalized anxiety disorder. Presented at the 161st Annual Meeting of the American Psychiatric Association, 2008. NR3-065.
2 National Institute of Mental Health: Anxiety Disorders. NIH Publication No. 06-3879. Available here. Accessed 5 August, 2008.
3 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000:472-475.
4 Bezerra de Menezes G, Fontenelle LF, Mulolo S et al. Treatment-resistant anxiety disorders: social phobic neurosis, generalized anxiety disorder and panic disorderliness. The Brazilian Journal of Psychiatry. 2007; 29(Supplement II):S55-60.
5 Nutt D, Argyropoulos S, Hood S et al. Generalized anxiety disorder: a comorbid disease. European Neuropsychopharmacology (2006) 16, S109-S118
6 Merideth C, Cutler LC196% Neijber A et al. Efficacy and tolerability of extended release quetiapine fumarate (Quetiapine XR) monotherapy in the treatment of GAD. twenty-first ECNP Congress, 2008.
7 Press release: AstraZeneca Submits sNDA for Seroquel XR� for the Treatment of Generalised Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines. 8 May 2008. See: hypertext transfer protocol://www.astrazeneca.com/pressrelease/5392.aspx. Accessed 5 August, 2008.
http://www.astrazeneca.com
View drug information on Seroquel.
More info
Subscribe to:
Posts (Atom)