Skip to main content
SpringerLink
Log in

Avanafil: A Review of Its Use in Patients with Erectile Dysfunction

  • Adis Drug Evaluation
  • Published:
Drugs & Aging Aims and scope Submit manuscript

Abstract

Avanafil (STENDRA™, SPEDRA™, Zepeeed™) is an oral phosphodiesterase type 5 inhibitor indicated for the treatment of erectile dysfunction. Avanafil is rapidly absorbed after oral administration, with a median time to maximum plasma concentration of 30 to 45 min. In a 12-week, randomized, double-blind, placebo-controlled, multicentre trial in patients with erectile dysfunction, avanafil 50, 100 and 200 mg recipients had significantly greater improvements from baseline than placebo recipients in mean international index of erectile dysfunction-erectile function domain scores and in successful vaginal penetration and sexual intercourse attempts (coprimary endpoints). Treatment effects were significantly larger in avanafil 100 and 200 mg recipients than 50 mg recipients. For avanafil recipients, approximately two-thirds of attempts at sexual intercourse that were made prior to 15 min, or more than 6 h, after drug administration were successful, compared with approximately one-quarter of attempts made during these time periods by placebo recipients. In trials in patients with erectile dysfunction in association with diabetes mellitus, and after nerve-sparing radical prostatectomy, avanafil 100 or 200 mg was significantly more efficacious than placebo for primary and most secondary endpoints. Avanafil was generally well tolerated in the above-mentioned studies. In a pooled analysis of three clinical trials, ≤2 % of avanafil and placebo recipients discontinued treatment because of adverse events. During extended treatment with avanafil for >52 weeks, 2.8 % of patients discontinued treatment because of adverse reactions and there were no drug-related serious adverse events.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig.1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Sivalingam S, Hashim H, Schwaibold H. An overview of the diagnosis and treatment of erectile dysfunction. Drugs. 2006;66(18):2339–55.

    Article  PubMed  CAS  Google Scholar 

  2. Rosen RC, Fisher WA, Eardley I, et al. The multinational men’s attitudes to life events and sexuality (MALES) study: I. prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin. 2004;20(5):607–17.

    Article  PubMed  Google Scholar 

  3. Seftel AD, Sun P, Swindle R. The prevalence of hypertension, hyperlipidemia, diabetes mellitus and depression in men with erectile dysfunction. J Urol. 2004;171(6 Part 1):2341–5.

    Google Scholar 

  4. Blanker MH, Bohnen AM, Groeneveld FPMJ, et al. Correlates for erectile and ejaculatory dysfunction in older Dutch men: a community-based study. J Am Geriatr Soc. 2001;49(4):436–42.

    Article  PubMed  CAS  Google Scholar 

  5. Basu A, Ryder RE. New treatment options for erectile dysfunction in patients with diabetes mellitus. Drugs. 2004;64(23):2667–88.

    Article  PubMed  CAS  Google Scholar 

  6. Nandipati KC, Raina R, Agarwal A, et al. Erectile dysfunction following radical retropubic prostatectomy: epidemiology, pathophysiology and pharmacological management. Drugs Aging. 2006;23(2):101–17.

    Article  PubMed  CAS  Google Scholar 

  7. Qassem A, Snow V, Denberg DT, et al. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Ann Int Med. 2009;151(9):639–49.

    Google Scholar 

  8. Hatzimouratidis K, Amar E, Eardley I, et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. European Association of Urology. Eur Urol. 2010;57(5):804–14.

    Article  PubMed  Google Scholar 

  9. Vivus, Inc. STENDRA™ (avanafil) tablets: US prescribing information [online]. 2012. http://www.avanafil.com/assets/pdf/STENDRA-avanafil-tablets-full-PI.pdf. Accessed 10 July 2013.

  10. European Medicines Agency. Spedra (avanafil) 50, 100, 200 mg tablets: summary of product characteristics. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002581/wc500145206.pdf. Accessed 8 July 2013.

  11. Vivus, Inc. Vivus announces FDA approval of STENDRA™ (avanafil) tablets for the treatment of erectile dysfunction [media release]. 2012. http://www.vivus.com. Accessed 27 April 2012.

  12. Wang R, Burnett AL, Omori K, et al. Avanafil, a highly selective phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction: selectivity for eleven PDE isozymes, in comparison with sildenafil, tadalafil and vardenafil (abstract). J Sex Med. 2012;9:49.

    Article  CAS  Google Scholar 

  13. Hellstrom W, Freier MT, Serefoglu EC, et al. A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction. BJUI. 2012;111(1):137–47.

    Article  Google Scholar 

  14. Jung J, Choi S, Cho SH, et al. Tolerability and pharmacokinetics of avanafil, a phosphodiesterase type 5 inhibitor: a single- and multiple-dose, double-blind, randomized, placebo-controlled, dose-escalation study in healthy Korean male volunteers. Clin Ther. 2010;32(6):1178–87.

    Article  PubMed  CAS  Google Scholar 

  15. Allison M, Grant T, Obaidi M, et al. Pharmacokinetics of avanafil; a novel, rapidly-absorbed, selective PDE5 inhibitor for the treatment of mild to severe erectile dysfunction (ED) (abstract). J Sex Med. 2011;8:466–7.

    Google Scholar 

  16. Obaidi M, Grant TM, Chai P, et al. Effect of hepatic insufficiency on the pharmacokinetics of avanafil, a new, potent, selective PDE-5 inhibitor, in male subjects (abstract no. PII-61). Clin Pharmacol Ther. 2012;91:S74–5.

    Google Scholar 

  17. Grant TM, Obaidi M, Chai P, et al. Effect of renal insufficiency on the pharmacokinetics of avanafil, a new, potent, selective PDE-5 inhibitor, in male subjects [abstract no. PIII-64]. Clin Pharmacol Ther. 2012;91:S119.

    Google Scholar 

  18. Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012;9(4):1122–33.

    Article  PubMed  CAS  Google Scholar 

  19. Goldstein I, Jones LA, Belkoff L, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012;87(9):843–52.

    Article  PubMed  CAS  Google Scholar 

  20. Mulhall JP, Burnett AL, Wang R, et al. A phase 3, placebo-controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve-sparing radical prostatectomy. J Urol. 2013;189(6):2229–36.

    Article  PubMed  CAS  Google Scholar 

  21. Mulhall J, Moul J, Wang R, et al. A phase III, placebo-controlled study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing radical prostatectomy [abstract]. J Sexual Med. 2012;9:42–3.

    Google Scholar 

  22. US FDA Center for Drug Evaluation and Research. Medical review avanafil. 2012. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202276Orig1s0001MedR.pdf. Accessed 15 June 2012.

  23. Park HJ, Park NC, Kim SW, et al. A randomized, placebo controlled, double blind, multicenter therapeutic exploratory clinical study for the evaluation of the efficacy and safety of avanafil in the patients with erectile dysfunction (abstract). J Urol. 2012;187(4 Suppl 1):e600.

    Google Scholar 

  24. Park JK, Park K, Kim SW, et al. Phase III clinical trial of avanafil in the treatment of erectile dysfunction [abstract]. J Sex Med. 2011;8:438.

    Google Scholar 

  25. Belkoff LH, McCullough A, Goldstein I, et al. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013;67(4):333–41.

    Article  PubMed  CAS  Google Scholar 

  26. Vivus, Inc. A randomized, placebo controlled, double blind, multicenter therapeutic confirmatory clinical study for the evaluation of the efficacy and safety of avanafil in patients with erectile dysfunction 2013. http://clinicaltrials.gov/ct2/show/NCT00903981. Accessed 15 July 2013.

  27. Vivus, Inc. A double-blind, stratified randomization, placebo controlled, parallel group, multicenter, dose escalation study to evaluate the efficacy and safety of avanafil in subjects with moderate to severe erectile dysfunction in Korea. 2013. http://clinicaltrials.gov/ct2/show/NCT01705197. Accessed 15 July 2013.

  28. Vivus, Inc. A randomized, double-blind, placebo-controlled evaluation of avanafil for on-demand treatment of men with erectile dysfunction. 2013. http://clinicaltrials.gov/ct2/show/NCT01698684. Accessed 15 July 2013.

  29. Vivus, Inc. Vivus announces study results showing STENDRA (avanafil) is effective for sexual activity within 15 min in men with erectile dysfunction (ED) (media release). 2013. http://files.shareholder.com/downoads/VVUS/19656413185x6717/28760ef7-ebdf-4833-9ba8-f060daba9e1a/VVUS_News_2013_6_19_General_Releases.pdf.

Download references

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from any comments received were made by the author on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Mark Sanford

Authors
  1. Mark Sanford
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mark Sanford.

Additional information

The manuscript was reviewed by: H Knegtering, Department of Psychiatry, University of Groningen, Groningen, The Netherlands; E. Serefoglu, Department of Urology, Tulane University, Kizilteppe, Turkey.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Sanford, M. Avanafil: A Review of Its Use in Patients with Erectile Dysfunction. Drugs Aging 30, 853–862 (2013). https://doi.org/10.1007/s40266-013-0112-x

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40266-013-0112-x

Keywords

Search

Navigation