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Silodosin is an α 1 -adrenoceptor antagonist with high uroselectivity.

History

Silodosin received its first marketing approval in Japan in May 2006 under the tradename Urief , which is jointly marketed by Kissei Pharmaceutical Co., Ltd. and Daiichi Sankyo Pharmaceutical Co., Ltd.

Kissei licensed the US, Canadian, and Mexican rights for silodosin to Watson Pharmaceuticals, Inc. in 2004.

On February 12, 2008, Watson announced that the New Drug Application submitted to the United States Food and Drug Administration for silodosin has been accepted for filing. FDA approved this drug on October 9th, 2008. Silodosin is marketed under the tradename Rapaflo .

Pharmacology

Since Silodosin is a highly selective inhibitor of the α 1A adrenergic receptor, it causes practically no orthostatic hypotension (in contrast to other α 1 blockers). On the other side, the high selectivity seems to cause more problems with ejaculation.

As alpha 1A-adrenoceptor antagonists are being investigated as a means to male birth control due to their ability to inhibit ejaculation but not orgasm, a trial with 15 male volunteers was conducted. While silodosin was completely efficacious in preventing the release of semen in all subjects, 12 out of the 15 patients reported mild discomfort upon orgasm. The men also reported the psychosexual side effect of being strongly dissatisfied by their lack of ejaculation. Despite the incidence of side effects, the drug still appears to be a promising candidate for a male oral contraceptive drug.

References

  1. ^ Yoshida M, Homma Y, Kawabe K (December 2007). "Silodosin, a novel selective alpha 1A-adrenoceptor selective antagonist for the treatment of benign prostatic hyperplasia". Expert Opin Investig Drugs 16 (12): 1955–65. doi:10.1517/13543784.16.12.1955. PMID 18042003 . http://www.expertopin.com/doi/abs/10.1517/13543784.16.12.1955 .  
  2. ^ "Drugs.com, Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia" . http://www.drugs.com/nda/silodosin_080212.html . Retrieved 2008-02-13 .  
  3. ^ Schubert-Zsilavecz, M, Wurglics, M, Neue Arzneimittel 2008/2009
  4. ^ Kobayashi K, Masumori N, Kato R, Hisasue S, Furuya R, Tsukamoto T. (December 2009). "Orgasm is preserved regardless of ejaculatory dysfunction with selective alpha1A-blocker administration.". Int J Impot Res. . PMID 18042003 . http://www.ncbi.nlm.nih.gov/pubmed/19536124 .  

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