Psychiatry - July 2008 - (Page 23)

[psych Rx] GI bleeding between 2001 and 2005. These cases were compared with 10,000 control subjects who were the same age and sex but did not have upper GI bleeding. Individuals with upper GI bleeding were significantly more likely than controls to be taking SSRIs (5.3% vs. 3.0%) or venlafaxine (1.1% vs. 0.3%). The risk of bleeding appeared to be increased further among those taking both SSRIs and other drugs known to be harmful to the GI tract, including nonsteroidal antiinflammatory drugs (NSAIDs, which include pain relievers such as ibuprofen or naproxen) and corticosteroids. Acid-suppressing agents, however, were associated with a reduced risk of upper GI bleeding in those taking SSRIs or venlafaxine. The researchers estimate that in patients not taking acid-suppressing agents, one individual per year would develop upper GI tract bleeding for every 2,000 patients taking these antidepressants. “When both SRIs [SSRIs and venlafaxine] and NSAIDs are concomitantly used, it would be sufficient to treat 250 patients per year for one case of upper GI tract bleeding to be attributed to such combination, and 500 patients per year if SRIs are concomitantly used with antiplatelet drugs,” the authors write. (ANDA) to market its generic version of Janssen’s antipsychotic agent Risperdal® (risperidone) tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg. Shipment of these products has commenced. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. The brand products had annual sales of approximately $2.6 billion in the United States for the 12 months that ended March 31, 2008, based on IMS sales data. The approval follows an April 11, 2008, order by the United States District Court for the District of Columbia granting a request of the Company’s subsidiary, Teva Pharmaceuticals USA, Inc., that the FDA relist in the Orange Book US Patent No. 5,158,952 and grant Teva 180-day exclusivity for its risperidone tablets. The FDA has appealed this decision and a hearing has been scheduled for September 12, 2008. FIRST RESULTS FOR PHASE IIA DATA OF UCB’S LACOSAMIDE FOR TREATMENT OF FIBROMYALGIA BRUSSELS, Belgium—UCB announced recently headline results based on first-line analyses of its Phase IIa clinical trial with lacosamide to treat fibromyalgia syndrome. The initial results from this proof of concept study showed activity of lacosamide in fibromyalgia syndrome but require further analysis. A decision to start Phase IIb will be made by the end of the year. This lacosamide trial was randomized, placebo controlled, and double blind to assess efficacy and safety of 400mg/day lacosamide tablets in patients suffering from signs and symptoms associated with TEVA RECEIVES FIRST US APPROVAL FOR GENERIC RISPERDAL TABLETS; COMMENCES COMMERCIAL LAUNCH JERUSALEM, Israel—BUSINESS WIRE—Teva Pharmaceutical Industries Ltd. announced recently that the US Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application fibromyalgia syndrome (FMS). This trial was designed to establish a signal to provide justification for further clinical development of lacosamide in FMS. The primary variable was a within-subject change in average daily pain score from baseline to the last two weeks of the treatment phase using an 11-point Likert scale. Based on 158 patients (randomized) of the full analysis set, an effect size of 0.5 in favor of lacosamide versus placebo was observed for the primary variable. Lacosamide was generally very well tolerated. About fibromyalgia syndrome: Fibromyalgia is characterized by chronic widespread musculoskeletal pain, tenderness, fatique, sleep disorders, morning stiffness and is associated with a number of other symptoms, such as cognitive dysfunction, mood disturbances, paresthesia, digestive disorders. About lacosamide: Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of fibromyalgia. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target collapsin-response mediator protein-2 (CRMP-2). Lacosamide has been filed with the US FDA and the EMEA for the treatment of epilepsy and diabetic neuropathic pain. Results in proof of concept trial encourage further analysis. Promising side effect profile observed. [JULY] Psychiatry 2008 23

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Psychiatry - July 2008 Editor's Message Editorial Advisory Board Contents PsychRx Letters to the Editor Reliability of Diagnoses: Do Psychiatrists Use Structured Interviews In Real Clinical Settings? Trend Watch: Use of Atypical Antipsychotics in the Elderly Review: The Struggle for Mental Healthcare in New Orleans-One Case at a Time Psychotherapy Rounds: Psychotherapeutic and Adjuntive Pharmacologic Approaches to Treating Posttraumatic Stress Disorder Original Research: Baseline Dissociation and Prospective Success in Special Forces Assessment and Selection Commentary: Performance-Enhancing Drugs: Where Should the Line Be Drawn and By Whom? Commentary: Psychiatric Diagnosis and the Pathlogist's View of Schizophrenia Journal Watch Classified Advertising Information for Authors

Psychiatry - July 2008

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