Table26. Exposure to Soolantra in clinical studies according to dose and duration. Study type/ Proposed dose Other dose Indication 3 mo. 6 mo. 12 Any 3 mo. 6 mo. 12 Any ≥ ≥ ≥ ≥ ≥ ≥ mo. dur’n mo. dur’n Clinical pharmacology 17 0 Indication 1 Vehicle-controlled1 1042 Active-controlled 839 784 717 14394 97 Uncontrolled 4843 Subtotal Indication 1 839 784 717 2027 97 TOTAL 839 784 717 2044 97 1 Excluding studies controlled by both vehicle and active. 2 Study RD.03.SRE.40106, median exposure 84 days. 3 Study RD.03.SRE.40051, median exposure 82 days. 4 Includes 478 subjects in Study RD.03.SRE.40173, with median exposure 113 days. The sponsor states: total of 2431 of the 3999 subjects in the clinical development program were exposed to ‘A Ivermectin 1% Cream: 268 healthy subjects and 2163 subjects with PPR. The figure of 2163 subjects with PPR includes 116 subjects exposed to Ivermectin 1% Cream BID, which was explored in Phase II before the QD regimen was confirmed for the Phase III program. Consequently, a total of 2047 subjects with PPR were exposed to the to-be-marketed formulation and regimen: Ivermectin 1% QD.’ Adverse events Note: In this section, a semicolon is used to separate observations relating to different patients. All adverse events (irrespective of relationship to treatment) Pivotal studies Study RD.06.SRE.18170 AE’s Study RD.06.SRE.18170 (see Table 27). Table 27. All AE’s Study RD.06.SRE.18170. Table 27 (continued). All AE’s Study RD.06.SRE.18170. Study RD.06.SRE.18171 AE’s Study RD.06.SRE.18171 (see Table 28).
Table26. Exposure to Soolantra in clinical studies according to dose and duration. Study type/ Indication Proposed dose Other dose ≥ 3 mo. ≥ 6 mo. ≥ 12 mo. Any dur’n ≥ 3 mo. ≥ 6 mo. ≥ 12 mo. Any dur’n Clinical pharmacology 17 0 Indication 1 Vehicle-controlled1 1042 Active-controlled 839 784 717 14394 97 Uncontrolled 4843 Subtotal Indication 1 839 784 717 2027 97 TOTAL 839 784 717 2044 97 1 Excluding studies controlled by both vehicle and active. 2 Study RD.03.SRE.40106, median exposure 84 days. 3 Study RD.03.SRE.40051, median exposure 82 days. 4 Includes 478 subjects in Study RD.03.SRE.40173, with median exposure 113 days. The sponsor states: ‘A total of 2431 of the 3999 subjects in the clinical development program were exposed to Ivermectin 1% Cream: 268 healthy subjects and 2163 subjects with PPR. The figure of 2163 subjects with PPR includes 116 subjects exposed to Ivermectin 1% Cream BID, which was explored in Phase II before the QD regimen was confirmed for the Phase III program. Consequently, a total of 2047 subjects with PPR were exposed to the to-be-marketed formulation and regimen: Ivermectin 1% QD.’ Adverse events Note: In this section, a semicolon is used to separate observations relating to different patients. All adverse events (irrespective of relationship to treatment) Pivotal studies Study RD.06.SRE.18170 AE’s Study RD.06.SRE.18170 (see Table 27). Table 27. All AE’s Study RD.06.SRE.18170. Table 27 (continued). All AE’s Study RD.06.SRE.18170. Study RD.06.SRE.18171 AE’s Study RD.06.SRE.18171 (see Table 28).
auspar-ivermectin-151209-cer_0.docx