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  • n. A drug for the symptomatic treatment of benign prostatic hyperplasia.


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  • Almirall to market silodosin, which is indicated for treatment of symptoms of benign prostatic hyperplasia, in Spain.

    GEN News Highlights

  • That process is not necessary with tamsulosin or the other newer alpha-blockers, alfuzosin (Uroxatral) and silodosin (Rapaflo).

    Flomax goes generic; more choices for men with enlarged prostate

  • The first of these was signed in April with Almirall which will co-market silodosin on the Spanish market together with Recordati España, our Spanish subsidiary.


  • - At the end of January 2010 Recordati was granted Marketing Authorization by the European Commission for the medicinal products Urorec® and Silodyx (TM) (silodosin) 4 mg, 8 mg, hard capsules, intended for treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).


  • - In preparation for the silodosin launch our network of partnerships was extended through the signature of three important license agreements for the marketing and sales of the drug.


  • Furthermore, in the active-controlled study conducted in Europe, silodosin 8 mg once daily was not inferior to tamsulosin 0.4 mg once daily, with an adjusted mean difference between treatments in the IPSS Total Score in favour of silodosin.

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  • In these studies, patients treated with silodosin had a significant decrease in BPH symptoms, both irritative (frequency, urgency, nocturia) and obstructive (hesitancy, incomplete empting, intermittency, weak stream).

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  • Furthermore, noeffects on cardiac repolarization were observed, even at high doses of silodosin.

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  • The safety of silodosin was extensively evaluated in a total of 1600 patients.

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  • No changes were seen in supine blood pressure or heart-rate, and the incidence of orthostatic hypotension was very low (1. 2% with silodosin, versus 1. 0% with placebo).

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