aviptadil/phentolamine mesilate (Invicorp)

following a full submission: 

aviptadil/phentolamine (Invicorp®) is accepted for restricted use within NHS Scotland.

Indication under review: For the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology.

SMC restriction: for use in those who have failed on oral therapies (oral phosphodiesterase type-5 inhibitors) and other non-injectable formulations of erectile dysfunction medications.

In an open-label, crossover study of men with non-psychogenic erectile dysfunction, aviptadil / phentolamine injection was compared with a prostaglandin-based intracavernosal injection. Patients who achieved an erection suitable for sexual intercourse (grade 3) from both treatments were entered into a comparative phase in which similar proportions of injections of each treatment resulted in grade 3 erections. Aviptadil / phentolamine injection was associated with a lower incidence of moderate or severe adverse events and pain when compared with the prostaglandin injection.