Duloxetine hydrochloride (brand names: Cymbalta/Yentreve) is a medically used drug that primarily targets major depressive disorders (MDD), pain related to diabetic peripheral neuropathy and stress urinary incontinence (SUI). Known also as LY248686, chemically (+)-(S)-N-methyl-3-(1-naphthyloxy)-2-thiophenepropanamine, it is a potent dual reuptake inhibitor of serotonin (5-hydroxytryptamine, 5-HT) and norepinephrine (NE), possessing comparable affinities in binding to NE and 5-HT transport sites. Its behavior contrasts to most other dual-reuptake inhibitors in that Ki values are nearly 1:1.

Furthermore, duloxetine lacks affinity for monoamine receptors within the central nervous system. While there is limited data available regarding the pharmacokinetic profile of duloxetine in humans, its half-life is reported to be 10 to 15 hours. Most common side effects in clinical trials were nausea, somnolence, and dry mouth. In clinical trials weight gain was neutral compared to placebo. Five people, including a 19-year old college student committed suicide while Eli Lilly was conducting preliminary trials. Ongoing studies including a 52 week safety and efficacy trial are available at [http://www.lillytrials.com www.lillytrials.com. Long-term side-effects seen in these trials did not vary from the original approval studies.

Duloxetine is approved by the FDA for the treatment of diabetic neuropathy. Approved dosages for treatment of diabetic peripheral neuropathic pain are 60 mg and 120 mg once daily.

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CFDA: FDA Latest Drug GCP Warning Letters

WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
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FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
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FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
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FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research

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