Cymbalta Showed Statistically Significant Reduction of Anxiety Symptoms in Depressed Patients.Business Editors/Health & Medical Writers PHILADELPHIA--(BW HealthWire)--May 22, 2002 New Data Demonstrate Effect of Cymbalta On Body Weight Similar to Placebo New clinical trial data on Cymbalta(TM) (duloxetine hydrochloride duloxetine hydrochloride Cymbalta Pharmacologic class: Selective serotonin and norepinephrine reuptake inhibitor Therapeutic class: Antidepressant Pregnancy risk category C ), an investigational serotonin serotonin (sĕr'ətō`nĭn), organic compound that was first recognized as a powerful vasoconstrictor occurring in blood serum. It was partially purified, crystallized, and named in 1948, and its structure was deduced a year later. and norepinephrine reuptake inhibitor Norepinephrine reuptake inhibitors (NRIs), also known as noradrenaline reuptake inhibitors (NARIs), are compounds that elevate the extracellular level of the neurotransmitter norepinephrine in the central nervous system by inhibiting its reuptake from the , suggest Cymbalta (pronounced sim-ball-ta) may reduce symptoms of anxiety in depressed patients at the starting dose. The data, presented today at a major psychiatric meeting included:-- Cymbalta 60mg administered once daily (QD), the target starting dose for depressed patients, demonstrated statistically significant reduction in anxiety symptoms compared to placebo on the Hamilton Depression Rating Scale Anxiety subscale (3.0 for Cymbalta vs. 1.99 for placebo; p=.004) -- Patients on Cymbalta experienced significant improvement in depressive symptoms regardless of the initial severity of their anxiety symptoms, (Cymbalta-treated patients with a HAMD Anxiety subscale baseline score less than 7 showed an 8.56 average reduction in their HAMD score (p=.002) and patients with a HAMD Anxiety subscale baseline score greater than or equal to 7 showed an average reduction of 9.97 (p=.05) both results were statistically significant from placebo. "Because anxiety is common in major depression, any first line antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. must show efficacy in treating anxiety symptoms. These data may suggest Cymbalta's potential impact in this facet facet /fac·et/ (fas´it) a small plane surface on a hard body, as on a bone. fac·et n. 1. A small smooth area on a bone or other firm structure. 2. of treatment," said Lilly research physician Michael Detke, MD, PhD. Approximately 60 percent of patients with major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder (MDD MDD Major depressive disorder, see there ) report symptoms of anxiety. Depressed patients with comorbid anxiety have a higher risk of recurrence recurrence /re·cur·rence/ (-ker´ens) the return of symptoms after a remission.recur´rent re·cur·rence n. 1. and suicide when compared to patients with only depression. Methodology Cymbalta was assessed by mean change in the HAMD17 total score (primary outcome measure). The HAMD anxiety subscale was also evaluated in the study of Cymbalta, 60 mg a day. Effect on body weight similar to placebo In other clinical trials up to 12 weeks, data presented today showed Cymbalta had little effect on body weight. Data from seven double-blind, placebo-controlled trials were aggregated for analysis and the findings suggest that patients taking Cymbalta did not experience clinically significant weight gain. Cymbalta-treated patients, in these trials, experienced an average weight loss of 1.11 pounds, while patients on placebo experienced an average weight gain of 0.55 pounds. In a one-year open label study, the average weight increase for patients on Cymbalta was 2.46 pounds. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. about the potential of the investigational compound Cymbalta in treating depression that reflect management's current beliefs. However, as with any pharmaceutical under development, there are risks and uncertainties in the process of development and regulatory review. There are no guarantees that future clinical trials will confirm the preliminary results reported in this release or that the product will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Exhibit 99 to the most recent Form 10-Q Form 10-Q See 10-Q. filed with the SEC in March 2002. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion