Avanafil marketed in the US under the brand name STENDRA has been developed by VIVUS Inc. (Mountain View, CA, USA)
June 1 2016

Vivus Inc, which is under intense pressure from its top shareholder over its marketing, said it signed a deal worth up to $121 million with Italy's Menarini Group to introduce its erectile dysfunction drug in Europe, Australia and New Zealand. Privately held Menarini will sell the drug, avanafil, as Spedra in Australia, New Zealand and 40 European countries. Avanafil has not been launched in the United States despite being cleared by the U.S. Food and Drug Administration more than a year ago because Vivus has been unable to find a partner to sell it - among the complaints of large shareholder First Manhattan Co.

Review
Patient Prefer Adherence. 2015. A comparison of the available phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction: a focus on avanafil. Numerous pathways can lead to erectile dysfunction (ED) in patients, with some patients having multiple causes. Regardless of the etiology, ED has been successfully treated in many patients with the advent of oral phosphodiesterase-5 inhibitors (PDE5Is). With the release of avanafil, there are currently four PDE5I options available, and choosing between them should be based on patient-specific considerations and preferences. vanafil along with the other PDE5Is has shown to be an effective oral treatment for ED, with avanafil's possible place in therapy for patients who want an on-demand option or as an alternative in patients who experience visual disturbances with the other agents.

Asian J Androl. 2014. Avanafil for male erectile dysfunction: a systematic review and meta-analysis. We carried out a systematic review and meta-analysis to assess the efficacy and safety of this drug for the treatment of ED. This meta-analysis indicates that avanafil 100 or 200 mg is an effective and well-tolerated treatment for ED. Compared with avanafil 100 mg, patients who take avanafil 200 mg are more likely to experience headaches.

Int J Clin Pract. 2013. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA Division of Urology, Albany College of Medicine, Albany, NY, USA Alvarado Hospital, San Diego, CA, USA Urology San Antonio, San Antonio, TX, USA VIVUS, Inc, Mountain View, CA, USA Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods:  This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; '100/200-mg' group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF). Results:  Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13 to 22 (100-mg group) and from 11 to 22 (100/200-mg group). Avanafil was effective in some patients. Sixty-five per cent of 'nonresponders' to avanafil 100 mg responded to the 200-mg dose. The most common treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events. Conclusions:  The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.

Ther Adv Urol. 2013. Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties. Department of Urology and Urological Oncology, Hannover Medical School, Hannover 30625, Germany. Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil.