Vectura announces positive data from clinical trial on its treatment for erectile dysfunction
21 Jul 2003
Vectura announces positive data from clinical trial on its treatment for erectile dysfunction
Vectura Limited, the UK-based speciality pharmaceuticals company, announced today the successful completion of a Phase IIa clinical study for its product, VR004 (inhaled apomorphine HCl), for the treatment of Erectile Dysfunction (ED). The study showed that VR004 improved 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 performance 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, sub-lingually or intra-nasally.
Study Details
The study evaluated the efficacy of, and tolerability to, 200µg, 400µg and 800µg 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.
Erectile performance was assessed in response to visual stimuli in a clinic setting using a modified version of Question 4 of the International Index of Erectile Function (IIEF) questionnaire.
The study demonstrated that, at doses of 400µg and 800µg, 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 200µg dose was 23%.
The onset of erections was notably rapid, with median onset times of 8 minutes following the 400µg and 800µg doses. The most rapid responses occurred in some patients 3 minutes after they received 400µg or 800µg 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.For further information please contact:
Vectura Limited
Dr Chris Blackwell COO
Tel: +44 (0)1249 667700
Fax: +44 (0)1249 667701
Email: chris.blackwell@vectura.com
Vectura Limited
Peter Virley
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
