Drug Pushers push Paxil CR...

February 17, 2004

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Study Shows Paxil CR (Paroxetine) Is Effective, Generally Well-Tolerated For

Patients With Social Anxiety Disorder

PHILADELPHIA, PA -- February 17, 2004 -- GlaxoKline's Paxil CRª

(paroxetine HCl) Controlled-Release Tablets is a generally well-tolerated

treatment for social anxiety disorder, according to a study published in the

February issue of the Journal of Clinical Psychiatry. In the study,

approximately three times as many patients taking Paxil CR achieved

remission compared to placebo. In addition, dropout rates due to adverse

events such as sexual dysfunction were low and comparable for both treatment

groups. These findings are important since discontinuation of treatment is a

well-recognized issue in managing social anxiety disorder.

Recently approved for the treatment of social anxiety disorder, Paxil CR is

the first and only controlled-release SSRI (selective serotonin reuptake

inhibitor) indicated for this condition. Paxil CR is also indicated for the

treatment of depression, panic disorder and premenstrual dysphoric disorder

(PMDD).

" This data are significant because it shows that patients with social

anxiety disorder, which is the most common anxiety disorder, who take Paxil

CR can effectively manage their symptoms with a low rate of patient dropouts

due to adverse events that are commonly associated with SSRIs, " said Dr.

Murray Stein, Professor of Psychiatry, University of California San Diego.

" Our hope is that patients will be better able to maintain a drug treatment

regimen, thus increasing the likelihood of remission and improved outcomes. "

Social anxiety disorder, also known as social phobia, is the most common

type of anxiety disorder, affecting millions of Americans. People with

social anxiety disorder have an intense fear of being scrutinized by other

people in social or performance situations. When exposed to " common " social

situations such as meetings, classes, parties, speaking in public and

talking to strangers or authority figures, people with social anxiety

disorder have literally become marked, " sick with fear, " and often develop

symptoms including rapid heartbeat, sweating, shaking and upset stomach.

Some people with social anxiety disorder avoid these situations all

together, severely limiting their life, work and social relationships.

Additionally, in 70 to 80 percent of cases, social anxiety disorder is

complicated by the presence of additional psychiatric conditions such as

depression or panic disorder, which add to the burden of the condition.

Paxil CR Significantly Improved Symptoms of Social Anxiety Disorder

In this multi-center, randomized, double-blind, placebo-controlled,

flexible-dose study, patients with social anxiety disorder were randomly

assigned to receive Paxil CR (paroxetine HCl) Controlled-Release Tablets

(flexible dose: 12.5 mg to 37.5 mg/day) (n=186) or placebo (n=184) for 12

weeks of treatment following a one-week, single-blind, placebo run-in

period. The primary efficacy measures were the change from baseline in the

Liebowitz Social Anxiety Scale (LSAS) and proportion of responders based on

the Clinical Global Impression (CGI), Global Improvement score.

Patients who received Paxil CR experienced a statistically significant

reduction in the LSAS total score and in both the Fear or Anxiety and

Avoidance subscales compared to those patients randomized to placebo. In the

CGI Global Improvement responder analysis, nearly twice as many patients

treated with Paxil CR achieved a score of " very much improved " or " much

improved, " compared to patients treated with placebo. Furthermore,

approximately three times as many patients treated with Paxil CR achieved

clinical remission, compared to patients treated with placebo.

The American Psychiatric Association (APA) recognizes discontinuation of

treatment as an issue to managing anxiety and depression. Studies show that

more than 40 percent of patients drop out of treatment within the first 90

days. To achieve full remission, the APA recommends continued treatment for

four to five months.

Controlled-Release Paxil CR Tablets

Paxil CRª (paroxetine HCl) Controlled-Release Tablets offers the proven

efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet

is a multi-layered formulation that controls dissolution and allows

absorption of the drug further down in the small intestine. Paxil CR offers

flexible dosing with three dosing strengths: 12.5 mg, 25 mg, and 37.5 mg.

Geomatrix technology is licensed from SkyePharma PLC (Nasdaq: SKYE/LSE:SKP).

Most common adverse events (incidence of 5 percent or greater incidence for

Paxil CR and at least twice that for placebo) in studies for major

depressive disorder, panic disorder, PMDD and social anxiety disorder

include infection, trauma, nausea, diarrhea, dry mouth, constipation,

decreased appetite, somnolence, dizziness, decreased libido, tremor,

yawning, sweating, abnormal vision, asthenia, insomnia, abnormal

ejaculation, female genital disorders and impotence. Patients should not be

abruptly discontinued from antidepressant medication, including Paxil CR.

Concommitant use of Paxil CR in patients taking monoamine oxidase inhibitors

(MAOIs) or thioridazine is contraindicated.

For more information on Paxil CR log on to http://www.paxilcr.com, or for

patients who are being treated with Paxil CR, visit CRBalance.com.

SOURCE: GlaxoKline

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February 17, 2004