Vectura announces positive data for ED treatment

Vectura Limited, the UK-based speciality pharmaceuticals company, has successfully completed a Phase IIa clinical study for its product, VR004 (inhaled apomorphine HCl), for the treatment of Erectile Dysfunction (ED).

The study showed that VR004 im-proved erectile performance with a rapid onset of action and demonstrated excellent tolerability at all doses tested. Additional studies to progress the clinical development of VR004 will be initiated in the near future. Vectura is pursuing licensing discussions with interested parties with a view to completing this process by the end of 2003.

'In a market where spontaneity is so important, the opportunity to provide such a well-tolerated, effective, and rapidly acting product, will clearly be of benefit to patients,' commented Vectura's ceo, Peter Virley.

'The results of this study are also of broader value to Vectura, since we have now proved the clinical concept for our formulation and device technologies in providing improved per-formance when delivering a systemically-active drug through the lungs.'

VR004 is inhaled and absorbed into the systemic circulation via the lungs. It is anticipated that delivery of drugs through the lungs will be more efficient; avoiding first-pass metabolism, requiring lower nominal doses and providing a faster onset of therapeutic activity than drugs delivered orally, sublingually or intranasally.

The study evaluated the efficacy of, and tolerability to, 200mg, 400mg and 800mg doses of VR004 in 35 patients with mild to moderate ED, in a placebo-controlled, escalating dose design. Doses were administered as dry powder formulations using Vectura's Aspirair device. Aspirair is a highly efficient, breath-actuated dry powder inhaler that does not rely upon co-ordination of device actuation with patient inhalation.

The study demonstrated that, at doses of 400mg and 800mg, VR004 improved erectile performance compared with placebo. The proportion of patients achieving Grade 3 or 4 erectile performance at these doses (indicating erections of sufficient quality for intercourse) was 49% and 59% respectively (placebo, 31%). The response rate following the 200mg dose was 23%.

The onset of erections was notably rapid, with median onset times of 8 minutes following the 400mg and 800mg doses. The most rapid re-sponses occurred in some patients 3 minutes after they received 400mg or 800mg doses.

Excellent tolerability was observed at all doses. No serious or severe adverse events were reported. All treatment related adverse events were mild or moderate. None of the patients discontinued the study as a result of treatment.

The International Index of Erectile Function (IIEF)

The IIEF is a validated questionnaire used for the evaluation of erectile performance and other indices of erectile dysfunction (Rosen et al. 1997. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. (Urology 49: 822-830). It has been used as a primary outcome variable in studies that have formed the basis of regulatory dossiers for approved ED products.