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avanafil (Spedra)

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.

Drug Details

Drug Name: avanafil (Spedra)
SMC Drug ID: 980/14
Manufacturer: A Menarini Pharmaceuticals UK Ltd
Indication: Treatment of erectile dysfunction (ED) in adult men. In order for avanafil to be effective, sexual stimulation is required
BNF Category:
Sub Category: 7.4 Drugs for genito-urinary disorders
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 7 September 2015

Archived Advice

Non submission 9 June 2014

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