4. Is the indication appropriate or should it specify the severity of acne? The ACPM advised that as the pivotal studies excluded subjects with severe acne the indication should be qualified. 5. Where would this product be placed in the treatment algorithm for acne? The clinical trials recruited subjects aged 12 y with moderate acne (GAAS score of 3). ≥ While conservative, non-pharmaceutical measures may improve such acne significantly, resolution is uncommon without maintenance topical and/or oral therapy. Resolution of acne within 12 weeks of topical dapsone as monotherapy is realistic for mild acne, but sustained resolution with no ongoing treatment is unlikely. Topical dapsone likely will be a used as an addition to existing treatment options for acne, in monotherapy, combination therapy and/or maintenance treatment. The ACPM expressed some concern over the lack of data on bacterial resistance. The ACPM advised to facilitate responsible management of antibiotic medicines as a general standard that all antibiotic use should be carefully monitored for the appearance of resistance. The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome Based on a review of quality, safety and efficacy, TGA approved the registration of Aczone dapsone 7.5% w/w topical gel bottle indicated for: The topical treatment of acne vulgaris in patients 12 years of age and older Specific conditions of registration applying to these goods The Aczone (dapsone) Australian RMP, version 1.0, dated 29 October 2015 (data lock point 31 May 2015), and any subsequent revisions, as agreed with TGA will be implemented in Australia Attachment 1. Product Information The PI approved for Aczone at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
4. Is the indication appropriate or should it specify the severity of acne? The ACPM advised that as the pivotal studies excluded subjects with severe acne the indication should be qualified. 5. Where would this product be placed in the treatment algorithm for acne? The clinical trials recruited subjects aged ≥ 12 y with moderate acne (GAAS score of 3). While conservative, non-pharmaceutical measures may improve such acne significantly, resolution is uncommon without maintenance topical and/or oral therapy. Resolution of acne within 12 weeks of topical dapsone as monotherapy is realistic for mild acne, but sustained resolution with no ongoing treatment is unlikely. Topical dapsone likely will be a used as an addition to existing treatment options for acne, in monotherapy, combination therapy and/or maintenance treatment. The ACPM expressed some concern over the lack of data on bacterial resistance. The ACPM advised to facilitate responsible management of antibiotic medicines as a general standard that all antibiotic use should be carefully monitored for the appearance of resistance. The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome Based on a review of quality, safety and efficacy, TGA approved the registration of Aczone dapsone 7.5% w/w topical gel bottle indicated for: The topical treatment of acne vulgaris in patients 12 years of age and older Specific conditions of registration applying to these goods The Aczone (dapsone) Australian RMP, version 1.0, dated 29 October 2015 (data lock point 31 May 2015), and any subsequent revisions, as agreed with TGA will be implemented in Australia Attachment 1. Product Information The PI approved for Aczone at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
auspar-dapsone-171201.docx