And from the 1999 AUA Meeting----

EFFICACY AND SAFETY OF APOMORPHINE SL
VS PLACEBO FOR MALE ERECTILE DYSFUNCTION (MED).
Harin Padma-Nathan, Santa Monica, CA; Stephen Auerbach, Newport Beach, CA; Ron Lewis, Augusta, GA; Michaelene Lewand, Renee Perdok, Deerfield, IL; and the Apomorphine SL Study Group (presented by Dr. Padma-Nathan)

INTRODUCTION AND OBJECTIVES: The dopaminergic agent, apomorphine, has known erectogenic properties. This Phase III study examines a novel sublingual formulation of apomorphine for efficacy and safety in patients with MED. Apomorphine SL for sublingual administration was formulated to improve tolerability while maintaining erectogenic effects. These are the results of a new study not previously presented, including a new apomorphine dose.
METHODS: In a multicenter, double-blind study, 520 patients with MED were randomized to four arms, each a separate crossover comparing either 2 mg, 4 mg, 5 mg, or 6 mg of apomorphine SL to placebo. The number of attempts resulting in an erection firm enough for intercourse was recorded as the primary endpoint.
RESULTS: The percentage of attempts resulting in an erection firm enough for intercourse was significantly higher for each of the four apomorphine SL doses than for placebo; 44.1% for 2 mg vs 38.0% for placebo (p=0.013); 58.1% for 4 mg vs 36.6% for placebo (p<.001); 52.7% for 5 mg vs 28.9% for placebo (p<.001), and 59.8% for 6 mg vs 30.8% for placebo (p<.001). The most common adverse event was nausea (mostly mild to moderate): 2.9%, 21.4%, 32.8% and 34.5% of patients for 2 mg, 4 mg, 5 mg and 6 mg, respectively. Only 2.6% of the 6 mg group and 0.8% of the 5 mg group experienced severe nausea (no severe nausea at lower doses).
CONCLUSIONS: Apomorphine SL, representing a new class of centrally acting oral drugs for the treatment of MED is well tolerated and efficacious.

SOURCE OF FUNDING----TAP Holdings Inc.

BACK