Cross-Study Review of the Clinical Efficacy of Apomorphine SL 2 and 3 mg:: Pooled Data from Three Placebo-Controlled,Fixed-Dose Crossover Studies

Background: Sublingual (SL) apomorphine is a nonopioid, centrally acting dopamine agonist developed to treat erectile dysfunction (ED). Clinical trials of the drug, using the most stringent and clinically relevant endpoints of “erections firm enough for intercourse”, have demonstrated its benefit in a wide variety of ED patients.Methods: Data were pooled and analyzed from three fixed-dose, placebo-controlled, double-blind, two-period crossover studies in which apomorphine SL 2 or 3 mg was evaluated against placebo for efficacy. Of the 415 patients who received both apomorphine SL (2 or 3 mg) and placebo, 252 received 2 mg and 163 received 3 mg. The clinical endpoints included erections firm enough for intercourse, per attempt intercourse rates and the International Index of Erectile Function (IIEF) criteria including the erectile function domain scores.Results: Apomorphine SL produced statistically significant improvements in a panel of erectile function measures, including erections firm enough for intercourse, total IIEF score, and IIEF domain scores. The proportion of patients achieving erections firm enough for intercourse was statistically significantly greater than placebo for both doses across all studies (p=0.001) and the ability to achieve an erection and have successful intercourse increased with sequential attempts. The percentage of attempts resulting in erections firm enough for intercourse was greatest in patients with mild or moderate ED; 89% of these patients who received at least eight doses of apomorphine SL 3 mg achieved adequate erections during treatment.Conclusions: Apomorphine SL 2 and 3 mg has significant benefit for men with ED as measured by all currently acceptable erectile function endpoints. An erection results as early as 10 minutes after dosing, and nearly 90% of erections occur within 30 minutes. Apomorphine SL is an appropriate first-line therapy for the management of ED, particularly in men presenting with mild to moderate dysfunction.