Vectura announces second successful clinical study on erectile dysfunction product
26 May 2004
Vectura announces second successful clinical study on erectile dysfunction product
Vectura Limited, the UK-based pulmonary products company, announced today the successful completion of a clinical study for its product, VR004 (inhaled apomorphine HCl), for the treatment of Erectile Dysfunction (ED).
The study demonstrated that VR004 was tolerated at doses up to and including 900µg, and is rapidly and efficiently absorbed following inhalation. Additional studies to assess the safety and efficacy of VR004 will be initiated during 2004.
Pharmacokinetic evaluations, conducted over a 24-hour period, validated the concept of rapid lung absorption and elimination when VR004 is delivered by inhalation. Maximum plasma concentrations were observed 1 to 3 minutes after dosing. Elimination of drug from plasma was relatively rapid, with a terminal half-life of approximately 60 minutes.
All treatment-related adverse events (AEs) were of mild to moderate severity. The majority of AEs were reported immediately post-dose, were transient in nature and resolved within minutes. No serious AEs were recorded and none of the subjects experienced syncope . There were no discontinuations for treatment-related reasons. Furthermore, no clinically relevant or significant changes in blood pressure, heart rate, electrocardiographic parameters or lung function tests were observed.
In a previous study in 35 mild to moderate ED patients, an improvement in erectile performance was achieved in 59% of patients. The median onset of this response was 8 minutes, with some subjects responding 3 minutes after dosing.
The delivery system for VR004 (Vectura proprietary formulation and Aspirair delivery device) has now been optimised since the previous study such that fine particle doses (i.e. the amount of drug that reaches the small airways of the lung) are achieved with lower inhaled doses."
Our aim with VR004 is to provide an effective and well-tolerated spontaneous treatment option for ED patients", commented Vectura's Chief Executive, Dr Chris Blackwell. "This study not only confirmed the rapid uptake of apomorphine via inhalation, which fits well with our product's onset of activity; it has also demonstrated that we have the scope to evaluate the efficacy of VR004 at even higher doses but still within a well-tolerated range." Dr Blackwell added, "Other apomorphine products may not have found the optimum therapeutic window for ED. We believe we will show in further studies that VR004, with its efficient delivery system, can achieve this."
For further information please contact:
Vectura Limited
Dr Chris Blackwell (CEO)
Tel: +44 (0)1249 667700
Fax: +44 (0)1249 667701
Email: enquiries@vectura.com
Financial Dynamics
David Yates / Lucy Briggs
Tel: + 44 (0) 207 269 7242
