DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

Fabi, Sabrina G.; Cohen, Joel L.; Green, Lawrence J.; Dhawan, Sunil; Kontis, Theda C.; Baumann, Leslie; Gross, Todd M.; Gallagher, Conor J.; Brown, Jessica; Rubio, Roman G.

doi:10.1097/dss.0000000000002531

Cited by 27 publications

(35 citation statements)

References 8 publications

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“…The efficacy of DAXI for the correction of glabellar lines in SAKURA 3 is discussed in detail in the companion article. 5 It is important to note that the safety profile of DAXI in SAKURA 3, which was similar to that of the pivotal Phase 3 trials and registration trials of other BoNTAs, was accompanied by a high rate of efficacy. More than 90% of subjects achieved a score of none or mild on the IGA-FWS as early as Week 1, a peak response across treatment cycles at 2 to 4 weeks (97%–98%) and, at Week 24, the response was maintained in 34.0% and 38.5% of subjects for Treatments 1 and 2, respectively.…”

Section: Discussionmentioning

confidence: 62%

“…More than 90% of subjects achieved a score of none or mild on the IGA-FWS as early as Week 1, a peak response across treatment cycles at 2 to 4 weeks (97%–98%) and, at Week 24, the response was maintained in 34.0% and 38.5% of subjects for Treatments 1 and 2, respectively. 5 …”

Section: Discussionmentioning

confidence: 99%

“…Safety results from this trial are reported here, with efficacy results in an accompanying publication. 5 …”

mentioning

confidence: 99%

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A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study

Green¹,

Coleman²,

Ablon

et al. 2020

Dermatol Surg

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Section: Discussionmentioning

confidence: 62%

Section: Discussionmentioning

confidence: 99%

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A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study

Green¹,

Coleman²,

Ablon

et al. 2020

Dermatol Surg

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“…To date, none of the currently available BoNTA products has consistently demonstrated a clinically distinct peak efficacy (response rate), duration of therapeutic benefit, or safety profile. DaxibotulinumtoxinA for Injection (DAXI; Revance Therapeutics, Inc., Newark, CA) is a novel BoNTA product, containing purified 150-kDa core neurotoxin and a proprietary excipient peptide, and is in clinical development for multiple therapeutic (cervical dystonia and upper limb spasticity) [12][13][14] and aesthetic indications (upper facial lines including glabellar lines, forehead lines, and lateral canthal lines) [15][16][17]. The formulation of DAXI and the clinical data from the extensive development program establish its role as a novel BoNTA with potential to improve upon the efficacy and safety of currently approved BoNTAs.…”

Section: Key Pointsmentioning

confidence: 99%

Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A

Solish

Carruthers

Kaufman³

et al. 2021

Drugs

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Botulinum toxin type A (BoNTA) products are widely used for therapeutic and aesthetic indications, but there is a need for longer-lasting treatments that maintain symptom relief between injections and reduce the frequency of re-treatment. DaxibotulinumtoxinA for Injection (DAXI) is a novel BoNTA product containing highly purified 150-kDa core neurotoxin and is the first to be formulated with a proprietary stabilizing excipient peptide (RTP004) instead of human serum albumin. The positively charged RTP004 has been shown to enhance binding of the neurotoxin to neuronal surfaces, which may enhance the likelihood of neurotoxin internalization. DAXI produces robust, extended efficacy across both aesthetic and therapeutic indications. In an extensive glabellar lines clinical program, DAXI showed a high degree of efficacy, a consistent median time to loss of none or mild glabellar line severity of 24 weeks, and median time until return to baseline of up to 28 weeks. In adults with cervical dystonia, DAXI at 125 U and 250 U significantly improved Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores, with a median duration of efficacy of 24 and 20 weeks, respectively, which compares favorably with the 12–14 weeks’ duration reported for approved BoNTA products. Overall, DAXI was well tolerated, and the consistent extended duration of effect suggests that DAXI has the potential to improve the management of both aesthetic and therapeutic conditions.

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“…Beyond a broader interest in improving patient outcomes, industry interest in conducting so-called “high-dose” studies may, in part, be driven by the 24-week median time to return to baseline (moderate or severe glabellar lines) observed for 40U of daxibotulinumtoxin A (DAX, Revance Therapeutics, Inc, Newark, CA, USA) 11 in clinical studies, a duration longer than that reported for other available products based on pivotal trial study dosing. 5-9 , 12 …”

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confidence: 99%

High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice

Fabi¹,

Carruthers

Joseph³

et al. 2021

Aesthetic Surgery Journal Open Forum

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Background For aesthetic treatment with botulinum toxin type A (BoNTA), interest in maximizing treatment duration and efficacy has prompted study of doses higher than those used in registration studies. As data emerge, it is important that physicians understand how to apply study findings to their own practice so that patient demand is satisfied in a meaningful way. Objectives To bring together leading experts in neuromodulators for a roundtable discussion on the implications of high-dose BoNTA studies for patient care. Methods The authors reviewed recent data from high-dose BoNTA studies for abobotulinum toxin A, incobotulinum toxin A, and Oonobotulinumtoxin A. Following this review, a moderated group discussion took place. Results Discussion focused on the challenges of data interpretation and extrapolation of study findings for real-world patient care. The authors participated in a candid discussion of whether the observed improvements in duration of treatment effect and patient satisfaction warrant treatment with high-dose regimens delivered as high-concentration injections. Safety was also discussed, as well as economic considerations for both practices and patients. Of note, for BoNTA products, the registration dose, when administered in a smaller total volume, appears to give rise to more durable results than those observed in pivotal trials, implicating product concentration as an important consideration. Importantly, at higher doses, extended duration of effect does not appear to be at the expense of natural-looking results. Conclusions While the authors provide considerations for the development of individual clinical practice, there is no one-size-fits all recommendation. It may be that “high-dose” BoNTA is in reality the optimal dose; however, important economic considerations may prevent rapid uptake in clinical practice for all patients.

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DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 27 publications

References 8 publications

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study

Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A

High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice

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