Selection of Investigational Medicinal Products and Dosages Sample Clauses

Selection of Investigational Medicinal Products and Dosages. Published data provide information from over 400 patients with NDO treated with doses ranging from 500 to 1000 U Dysport®. Across a number of clinical studies, all doses were reported as efficacious. However, the 500 U dose has been reported to be less effective compared to higher doses [15, 11], while the 1000 U dose was associated with a higher incidence of treatment-related AEs [10, 11, 13]. Results from the Ipsen placebo controlled phase IIa study, which used the exploratory dose of 750 U, demonstrated a favourable benefit/risk balance [17] (Section 1.3.2). It is expected that a difference of 200 U will allow dose discrimination based on the balance between efficacy and safety; therefore, for phase III, doses of 600 U and 800 U have been selected for further evaluation. The dose of 600 U is anticipated to have greater efficacy than that reported with 500 U; while the 800 U dose is expected to demonstrate a higher degree of efficacy, without jeopardizing the safety profile and thus providing a second clinically relevant dose. Thus, it is anticipated that with a 200 U difference, the two doses are sufficiently differentiated to enable an evaluation of the benefit/risk of both doses without significantly increasing the safety risk.
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Related to Selection of Investigational Medicinal Products and Dosages

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