Psychiatry - July 2008 - (Page 17)

[psych Rx] night is critical. Patients currently experience unpredictability in managing their disease on a daily basis. The results of the PREPARED study verify that Requip-Modutab is extremely effective in treating the complex, unpredictable nature of the disease. By using the Requip-Modutab treatment approach, patients are able to achieve clinically more significant outcomes compared with the intermittent delivery of ropinirole three-times daily. The improvement in symptom control provided by Requip-Modutab should significantly improve patients’ quality of life.” The study compared two treatment approaches using oncedaily Requip-Modutab and the ropinirole three-times daily formulation as adjunct therapy in patients with advanced PD. Patients using Requip-Modutab maintained a reduction in ‘off’ time versus those taking ropinirole three times daily (66% vs 51%) and were able to achieve a greater reduction in Ldopa dose compared with the threetimes daily formulation. By using Requip-Modutab, patients are more easily able to access the full range of doses. Therefore, the most clinically appropriate treatment dose can be reached more rapidly and simply than with ropinirole three times daily. While patients were able to reach higher doses with Requip-Modutab (mean dose of 18.6mg/day vs. 8.9mg/day with ropinirole 3x daily), both treatment formulations were generally well tolerated. Data from the study confirm that patients taking adjunctive RequipModutab demonstrate significant improvement on the CGI-I scale (54% vs. 42% for ropinirole 3x daily) highlighting better patient outcomes with the Requip-Modutab treatment approach compared with intermittent delivery of ropinirole three times daily. In addition, a recent adherence survey suggests that therapies that offer simplified dosing regimens and provide less intermittent dosing during the day may reduce tablet burden, improve adherence and result in optimal symptom management. Interim results from a pan-European survey revealed that 42 percent of PD patients (n= 1,026) needed to plan their day around the times they take their medication, highlighting an unmet need for simplified treatment regimens. Requip-Modutab uses SkyePharma PLC’s patented GEOMATRIX® technology. The new formulation has been developed to provide a continuous delivery of ropinirole over 24 hours, resulting in reduced fluctuations in plasma concentrations associated with ropinirole three-times daily. RequipModutab is the first and only oral nonergot once-daily dopamine agonist for the treatment of PD. For more information, visit www.gsk.com. lose patent protection in the coming years. Cymbalta sales surged 37 percent to $605 million in the first quarter. Fibromyalgia is estimated to affect two percent of Americans, or about 5 million people, according to Lilly. Cymbalta reduced pain compared with a placebo in two clinical trials involving 874 fibromyalgia patients, the company said. Cymbalta, which works by maximizing the effects of two brain messenger chemicals, has now won US approval for addressing four disorders. Aside from fibromyalgia, the drug is cleared for treating major depressive disorder and generalized anxiety disorder, as well as for management of diabetic peripheral neuropathic pain. FDA APPROVES CONCERTA (METHYLPHENIDATE HCI) EXTENDED-RELEASE TABLETS FOR TREATMENT OF ADHD IN ADULTS Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&JPRD) announced the US Food and Drug Administration (FDA) approved J&JPRD’s Supplemental New Drug Application (sNDA) for CONCERTA® for treatment of ADHD in adults ages 18 to 65. The doses approved for adults range from 18 to 72mg daily. This approval expands the CONCERTA indication from children and adolescents into adults with ADHD, and offers these patients a patented once-daily formulation. Using its unique OROS® delivery system, the CONCERTA formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day. [JULY] US APPROVES LILLY’S CYMBALTA FOR FIBROMYALGIA NEW YORK (Reuters)—Eli Lilly and Co. said recently its antidepressant Cymbalta won US approval for addressing the pain condition fibromyalgia, opening up a new market that could propel the drug’s sales. Pharmaceutical companies have been racing to bring drugs to market for fibromyalgia, a sometimes debilitating disorder that affects mostly women. Cymbalta’s approval follows clearance in fibromyalgia for Pfizer’s Lyrica. Lilly has been counting on Cymbalta sales to offset slowing sales of its Zyprexa schizophrenia treatment, which is expected to Psychiatry 2008 17 http://www.gsk.com

Table of Contents Feed for the Digital Edition of Psychiatry - July 2008

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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