SMITHKLINE BEECHAM SUBMITS MARKET APPLICATION TO FDA FOR PAXILŽ TO TREAT POSTTRAUMATIC STRESS DISORDER (PTSD)

PTSD Affects Up to 1 out of 7 Americans

Philadelphia, PA, July 24, 2000

 
- SmithKline Beecham (NYSE:SBH) announced today that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for PaxilŽ (paroxetine HCl). The company is seeking marketing approval of Paxil for the treatment of posttraumatic stress disorder (PTSD), a condition that develops as a result of exposure to a traumatic event followed by reexperiencing the event, avoidance and hyperarousal. Traumas may include experiencing or witnessing assault or abuse, a serious accident, a natural disaster, or observing a violent death. Paxil, a selective serotonin reuptake inhibitor (SSRI), is currently indicated for the treatment of depression, panic disorder, obsessive-compulsive disorder and social anxiety disorder, and is under FDA review for the treatment of generalized anxiety disorder (GAD).

"Paxil is a broad-spectrum medication that is already approved to treat a variety of mood and anxiety disorders, the symptoms of which show extensive overlap with posttraumatic stress disorder, such as depression and social anxiety disorder," said Randall D. Marshall, M.D., assistant professor of clinical psychiatry at Columbia University. "With few highly effective treatments currently available to treat posttraumatic stress disorder, Paxil may help us improve the lives of people with this debilitating condition."

Data Shows Paxil Reduces Symptoms of PTSD

A clinical program involving nearly 1,200 patients with the diagnosis of PTSD was conducted to evaluate the therapeutic efficacy and safety of Paxil. The data collected demonstrated statistically superior benefit for Paxil over placebo in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-2) and the Clinical Global Impression Scale (CGI), both established standards. Patients in the study were men and women between 18 and 78 years old, with the average age being 40.

PostTraumatic Stress Disorder: Not a Normal Reaction to Trauma

Affecting up to one out of 7 individuals at some point in their lives, PTSD affects twice as many women as men. PTSD symptoms can occur at any age and usually appear within three months of the trauma, but can potentially happen years later. People must experience symptoms for more than one month to be diagnosed with the condition.

Reexperiencing, numbing/avoidance and hyperarousal are hallmark symptoms of PTSD. Reexperiencing includes "flashbacks" or nightmares recounting the trauma, or intrusive thoughts. Emotional numbing/avoidance includes loss of interest and motivation and many sufferers avoid activities, places, people, or topics associated with the trauma. Hyperarousal includes being easily startled, irritable and having difficulty concentrating and sleeping. This disorder can significantly impair the lives of those who suffer from it.

Other Psychiatric Disorders Associated with PTSD

According to the National Comorbidity Survey (NCS), a majority of PTSD sufferers also meet criteria for another psychiatric disorder. For example, nearly 50 percent of individuals with PTSD also suffer from depression and 28 percent suffer from social anxiety disorder. Additionally, PTSD sufferers are two to three times more likely to have a drug or alcohol abuse problem. Research also has shown that there is a substantial rate of suicide attempts among PTSD sufferers.

What Constitutes a Trauma?

According to the NCS, the most common types of trauma are witnessing someone being injured or killed, physical attacks and threat by weapons, being involved in fire, flood or other natural disaster, and accidents. In addition to those who actually experience a trauma, witnesses of traumatic events may also suffer symptoms of PTSD. Some witnessed events include observing the serious injury or unnatural death of another person due to violent assault, serious accident or serious injury experienced by a family member or close friend, or learning that one's child has a life-threatening disease.

"It is a common misconception that posttraumatic stress disorder only occurs in war veterans," said Dr. Marshall. "Survivors of serious car accidents, rescue workers and those who experience the violent unexpected death of a close friend or family member can also be at risk for this disorder."

Paxil is generally well tolerated. As with many medications, there can be side effects. The most common side effects reported in depression, obsessive compulsive disorder, panic disorder or social anxiety disorder studies include asthenia, sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, yawn and sexual side effects in men and women. People taking MAO inhibitors should not take Paxil. Most people who experience side effects are not bothered enough to stop taking Paxil.

SmithKline Beecham-one of the world's leading healthcare companies-discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products.