Advice

following a full submission

avanafil (Spedra®) is not recommended for use within NHS Scotland.

Indication under review: Treatment of erectile dysfunction (ED) in adult men. In order for avanafil to be effective, sexual stimulation is required.

The pivotal studies demonstrated a statistically significant improvement in ED after administration of avanafil compared with placebo in the general ED population and in patients with ED due to diabetes or following radical prostatectomy.

The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

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Medicine details

Medicine name:
avanafil (Spedra)
SMC ID:
980/14
Indication:
Treatment of erectile dysfunction (ED) in adult men. In order for avanafil to be effective, sexual stimulation is required
Pharmaceutical company
A Menarini Pharmaceuticals UK Ltd
BNF chapter
Obstetrics, gynaecology, and urinary-tract disorders
Submission type
Full
Status
Not recommended
Date advice published
07 September 2015