vardenafil (Levitra)

Advice

following a full submission

vardenafil orodispersible tablet (Levitra®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of erectile dysfunction (ED) in adult men. ED is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for vardenafil to be effective, sexual stimulation is required.

SMC restriction: use is restricted to patients in whom an orodispersible tablet is an appropriate formulation. Vardenafil is subject to the same NHS prescribing restrictions as other drug treatments for erectile dysfunction in terms of National Health Service (General Medical Services) (Scotland) regulations.

Two placebo controlled, studies have shown that vardenafil orodispersible is significantly better than placebo in the treatment of erectile dysfunction in men.  No comparative evidence against other medicines for erectile dysfunction was presented.