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Pagoclone Significantly Reduces Frequency Of Panic Attacks LEXINGTON, MA -- November 20, 1997 -- Interneuron Pharmaceuticals, Inc. today announced that a Phase II study among patients suffering from panic disorder showed treatment with pagoclone significantly reduced their frequency of panic attacks. Also, pagoclone was well-tolerated without evidence of sedation or withdrawal effects. The study, supported by Interneuron, was a two-week double-blind placebo-controlled cross-over study involving 16 patients with panic disorder. It was conducted by a team of researchers led by David Nutt, M.D., professor of psychopharmacology at the School of Medical Sciences at the University of Bristol, United Kingdom. Panic disorder is a severe anxiety condition characterized by panic attacks, comprised of distressing symptoms, such as difficulty breathing, sweating, heart palpitations, feeling dizzy or faint and fear of losing control. There are over 20 million patients in the United States with anxiety disorders including panic disorder. Patients were enrolled into the study with a confirmed diagnosis of panic disorder who had two to 10 panic attacks per week in the two weeks prior to enrollment. Following the two-week screening period during which baseline panic attack data were gathered, eligible patients were randomized to receive pagoclone 0.1mg TID (0.3mg/day) or placebo for two weeks (weeks one and two). All patients received placebo wash-out during week three. During weeks four and five, patients who had initially received pagoclone received placebo and vice versa. A final placebo wash-out period occurred during week 6. Outcome measurements included change in the number of full and partial panic attacks, withdrawal and rebound anxiety symptoms. The data from the study will be submitted for presentation at the Collegium Internationale Neuro-Psychopharmacologicum (CINP), a neuropsychopharmacology meeting, in Glasgow in July 1998. This study was the first clinical trial designed to assess the efficacy of pagoclone in panic disorder. It was powered to detect trends rather than statistically significant differences between placebo and pagoclone treatment. Nevertheless, pagoclone produced a significant reduction (40 percent) in the total number of panic attacks over a two week treatment period and a reduction (40 percent) in the average number of panic attacks per day compared to the pre-treatment period. No significant change in the total number of panic attacks was observed during placebo treatment. Pagoclone treatment was well-tolerated with no evidence of sedation and no apparent withdrawal or rebound anxiety effects, common issues with older benzodiazepine anti-anxiety drugs such as diazepam and alprazolam. "This study provides clinical support for the hypothesis that the administration of pagoclone is of significant benefit in panic disorder," Dr. Nutt said. "We are encouraged by the rapid onset of action seen among patients in this study, as well as by the absence of sedative effects and withdrawal symptoms." Interneuron is currently conducting a multi-center Phase 2/3 study on pagoclone in the U.S. for the treatment of panic disorder. The study is comparing the effects of three doses of pagoclone, including the dose tested in Nutt's study, to placebo in treating panic disorder during a 10-week period (0.15mg/day, 0.3mg/day, 0.6mg/day). Primary outcome measures will include the frequency of panic attacks experienced by patients. Approximately 200 of 280 patients have been enrolled in this study, and completion is expected in mid-1998. Anxiety disorders, including panic disorder, are believed to be associated with excessive neuronal activity resulting from a decrease in the function of the major inhibitory neurotransmitter called GABA (gamma amino butyric acid). Pagoclone, a partial agonist at a modulatory site on the GABA receptor, is believed to enhance the action of GABA in the brain, thereby reducing the excessive neuronal activity associated with anxiety and panic attacks. A particular benefit of a partial agonist is a reduction in the propensity for unwanted effects, such as sedation and withdrawal. Dr. Nutt noted the present study is consistent with this expectation. More information on: Pagoclone , Interneuron E-mail this page to a friend or colleague! To print, use this version