New huge market for Paxil - Social Anxiety Disorder
I'm not sure how this works. This may be off label for SKYEY's Paxil-R. But the longer lasting formulation of Paxil would, IMHO, seem to be very attractive. Paxil-R may be a cash cow for SKYE.
John de C
FDA Approves Paxil In The U.S. For Social Anxiety Disorder
PHILADELPHIA, PA -- May 11, 1999 -- The United States Food and Drug Administration has approved SmithKline Beecham's Paxil(R) (paroxetine HCl) for the treatment of social anxiety disorder, making it the first and only medication approved for this disorder in the U.S.
Affecting over 10 million Americans, social anxiety disorder, also known as social phobia, is the most common type of anxiety disorder and the third most common psychiatric disorder after depression and alcoholism. Social anxiety disorder is also considered one of the most neglected anxiety disorders, with only five percent of patients receiving some form of treatment.
People with social anxiety disorder have an intense fear of being scrutinised by other people in social or performance situations and of negative evaluation. They literally become sick with fear and are afraid of acting in a way that will be embarrassing or humiliating, causing them to avoid such situations in the future or endure these everyday situations with dread. These situations may include speaking in public, initiating or maintaining a conversation with strangers or people in authority, participating in meetings or classes, attending parties or dating.
"The FDA approval of Paxil for the treatment of social anxiety disorder provides a much-needed addition to the physician's armamentarium against mental illness," said Rodrigo Munoz, M.D., president of the American Psychiatric Association and clinical professor of psychiatry, University of California at San Diego. "The FDA's action has given psychiatrists and other physicians an approved option from which to develop effective treatment plans for this debilitating disorder -- usually combining medication and some form of psychotherapy."
Paxil was significantly more effective than placebo in treating social anxiety disorder, based on results from three 12-week multicentre, placebo-controlled trials of adults. In all studies, Paxil significantly reduced social anxiety, increased participation in social activities and improved the overall clinical condition of patients with social anxiety disorder as measured by the Clinical Global Impression (CGI) score (a commonly used measure of disease burden) and the Liebowitz Social Anxiety Scale (LSAS).
In one study, 69 percent of patients treated with Paxil (20 to 50 mg daily) responded to treatment(compared to only 29 percent of patients given placebo) at week 12. All three studies confirmed that Paxil is safe and well-tolerated.
"Many patients treated with Paxil had a very clinically meaningful response to the medication -- experiencing reduction in their anxiety and disability and improvement in their overall functioning," said Murray Stein, M.D., professor of psychiatry at the University of California at San Diego and lead investigator of two pivotal trials.
In social anxiety disorder patients, the most commonly observed adverse events associated with the use of Paxil (incidence of five percent or greater and incidence for Paxil at least twice that for placebo) were sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders and impotence.
Concomitant use of Paxil in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated.
Many people with social anxiety disorder also suffer from other mood and anxiety disorders such as depression, panic disorder and obsessive compulsive disorder. In one study of social anxiety disorder patients who developed comorbid alcoholism, panic disorder or depression, social anxiety disorder preceded the onset of alcoholism, panic disorder and depression in 75 percent, 61 percent and 90 percent of patients, respectively.
"Since Paxil is approved to treat a variety of mood and anxiety disorders such as depression and panic disorder, this medication may help physicians stem the downward spiral of symptoms and conditions that so often occur in connection with social anxiety disorder," said Jack Gorman, M.D., professor of psychiatry at the College of Physicians and Surgeons at Columbia University.
Social anxiety disorder is not just shyness. Shyness may involve uncomfortable feelings in social situations, but social anxiety disorder is a clinical diagnosis that is much more pervasive, distressing and interferes with normal functioning.
For example, normal anxiety reaches a peak during the initial minutes of interaction with an authority figure and generally diminishes shortly thereafter, allowing people to successfully accomplish their goal. However, the sustained level of intense anxiety experienced by people with social anxiety disorder can severely impair their ability to interact with their boss and may prevent them from getting a promotion or assuming new responsibility because they avoid the interaction altogether.
"I've seen people treated for social anxiety disorder be able for the first time to comfortably negotiate business meetings or attend social events, where previously their anxiety overwhelmed them," Dr. Gorman said. "It is our hope that patients will now know that they are not alone, that their disease has a name and it is treatable if they talk to their doctor."
Paxil is a selective serotonin reuptake inhibitor (SSRI) that has been used to treat a range of mood and anxiety disorders in more than 60 million patients world-wide. Of all the SSRIs, Paxil has the most FDA-approved indications, namely depression, panic disorder, obsessive compulsive disorder and now social anxiety disorder. |
