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The Pharmaceutical Journal
Vol 271 No 7261 p170
9 August 2003

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Vectura (www.vectura.co.uk)
Futura Medical (www.futuramedical.com)


Inhaled apomorphine promising for erectile dysfunction treatment

An inhaled form of apomorphine has shown promise as a fast-acting treatment for erectile dysfunction.

Developed by Vectura, VR004 is a breath actuated, dry-powder inhaler device containing apomorphine hydrochloride. New clinical trial data have shown that it could produce an erection sufficient for intercourse as soon as three minutes after dosing.

In Phase IIa clinical trials doses of 200µg, 400µg and 800µg were administered to 35 patients with mild to moderate erectile dysfunction in a placebo controlled, escalating dose design. Erectile performance was assessed in response to visual stimuli in a clinic setting using a modified version of the international index of erectile function questionnaire. Erections of sufficient quality for intercourse were achieved by 59 per cent of patients receiving 800µg apomorphine and 49 per cent of patients receiving 400µg compared to 31 per cent of patients receiving placebo. The response rate for patients receiving 200µg was 23 per cent. The median time for onset of erection was eight minutes following administration of 400µg and 800µg doses, the most rapid response rate being three minutes. Vectura states that the drug was well tolerated, with no serious or severe adverse events reported.

The company expects that the inhalation route will prove more efficient than oral, sublingual or intranasal delivery by avoiding first-pass metabolism, requiring lower doses of active drug and providing a faster onset of therapeutic activity.

Topical treatments Futura Medical has completed a phase II study of a rub-on vasodilator cream for the treatment of male erectile dysfunction. They are also developing a condom that incorporates an erection-enhancing compound.

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