Register for Phase II Intranasal Apomorphine Trial Initiated
Erectile DysfunctionNovember 13, 2000
(NewsRx.com) -- Nastech Pharmaceutical Company Inc. (NSTK), Hauppauge, New York, announced initiation of a Phase II at-home efficacy trial using its proprietary intranasal Apomorphine HCI formulation for the treatment of male erectile dysfunction.
Nastech presented intranasal apomorphine clinical data for male and female sexual dysfunction at the Female Sexual Function Forum in Boston, Massachusetts, during October 2000. Results from a pilot Phase II efficacy study in men and a Phase I pharmacokinetics study in women indicate Nastech's intranasal apomorphine product is safe and well tolerated, with no observations of serious side effects.
Nastech's Phase II trial is a randomized, double-blind, placebo-controlled, at-home safety and efficacy study involving 180 male patients ranging in age from 18-65 with erectile dysfunction of both psychogenic and organic origin.
The study design consists of three 60-patient dosing arms in which various doses of intranasal apomorphine will be administered against placebo. Efficacy will be determined by a contemporaneous IIEF questionnaire and diary to be completed after each dose. The protocol has received IRB approval, and the first patient dosing should occur in November 2000.
In a previous pilot Phase II safety and efficacy in-clinic study of 21 patients suffering from erectile dysfunction, 14 of the 17 (82%) subjects that achieved erection reported "sufficient erection" for sexual intercourse after the administration of a 0.50 mg dose of Nastech's intranasal apomorphine formulation. Only 67% reported the same results after taking Viagra, and 39% reported the same result taking a nasal placebo. At the same dosage level, there were no serious side effects in the study, including no observations of dizziness, sweating, vomiting, hypotension, or syncope. Other companies have seen significant side effects for apomorphine products under development by non-nasal routes.
At the Female Sexual Function Forum, Nastech also presented Phase I pharmacokinetic data on the administration of intranasal apomorphine in 12 healthy female subjects, which indicated the formulation to be safe and well tolerated. Nastech is planning studies to evaluate the efficacy of intranasal apomorphine HCI formulation in an at-home setting in patients suffering from female sexual dysfunction.
This article was prepared by Health & Medicine Week editors from staff and other reports.
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