Navigating Daxxify’s Potential in the Aesthetic Landscape

Since its approval in September 2022, Daxxify™ (daxibotulinumtoxinA-lanm) has emerged as a notable player in the field of neuromodulators, offering a unique formulation and promising long-lasting results.¹ In this article, we aim to explore the experiences and insights of dermatology clinicians who have used both Daxxify and Botox® (onabotulinumtoxinA) in their practices.²

Botox, approved by the FDA in 1989, initially found its purpose in treating eye muscle disorders such as blepharospasm and strabismus.3 Over time, its cosmetic applications expanded, and it became widely recognized for its ability to reduce facial wrinkling. In 2002, Botox gained FDA approval for cosmetic purposes, specifically for the temporary improvement in the appearance of moderate-to-severe glabellar lines. This pivotal moment brought about a paradigm shift in the field of cosmetic dermatology, leading to significant growth in the aesthetic industry and the development of new injectable treatments.

With a well-established safety profile when administered by trained medical professionals, Botox has become a go-to treatment for patients seeking a more youthful appearance. Although some potential side effects exist, serious complications are rare when the treatment is performed by experienced clinicians. Today, Botox enjoys global popularity and is a multi-billion-dollar product, with a global market size of $5.9 billion in 2021.

In contrast, Daxxify, approved by the FDA in 2022, represents a significant innovation in neuromodulator product formulation; it is the first and only peptide-formulated neuromodulator with long-lasting results. Powered by Peptide Exchange Technology, Daxxify represents a neuromodulator with an extended duration of treatment effect. Clinical data from the phase 3 SAKURA clinical program demonstrated that Daxxify delivers a median duration of 6 months and up to 9 months for some patients.4

To delve into the experiences and insights of dermatology clinicians, we reached out to Sue Ellen Cox, MD, FAAD, a dermatologic surgeon, researcher, and the founder/director of Aesthetic Solutions in Chapel Hill, NC. Dr. Cox conducts trials on neuromodulators and injectables. We also spoke with Brian S. Biesman, MD, a clinical professor at Vanderbilt University Medical Center specializing in cosmetic and reconstructive eyelid and facial surgery, as well as minimally invasive rejuvenation techniques. These two practicing experts will expand upon the differences in Daxxify’s formulation, its advantages and disadvantages, the recommended patient population, patient interest in Daxxify, and the clinicians’ perspectives on its future usage.

Modern Aesthetics: When considering Daxxify’s formulation in relation to other FDA-approved neuromodulators, what sets it apart and makes it unique?

Dr. Cox: Daxxify’s formulation incorporates an excipient peptide known as RTPOO4, which plays a crucial role in stabilizing the active molecule. This peptide possesses a high positive charge, while nerve terminals carry a negative charge, potentially enhancing Daxxify’s retention at the neuromuscular junction and promoting effective binding. Additionally, the excipient peptide prevents Daxxify aggregation on the vial’s surface during preparation and administration in the clinic, ensuring minimal product loss. This thoughtful design contributes to Daxxify’s efficacy and efficient clinical application.

Dr. Biesman: Daxxify distinguishes itself with a novel excipient protein, devoid of “accessory proteins,” and free from human serum albumin.

MA: What specific advantages does Daxxify offer that differentiate it in terms of efficacy, safety, and patient outcomes?

Dr. Cox: Daxxify is supported by the largest phase 3 clinical trial ever conducted for a toxin treatment targeting frown lines, involving over 3800 patients. It stands as the sole FDA-approved neuromodulator with a notable 6-month median duration of effect in the glabella. With its introduction, Daxxify enriches the range of available neuromodulators, affording healthcare providers the option to offer their patients an effective, fast-acting, safe, and potentially longer-lasting product. This notable addition may bridge a significant gap for patients seeking optimal treatment outcomes aligned with their specific needs and preferences.

Dr. Biesman: Daxxify demonstrated exceptional clinical performance, outperforming Botox in a head-to-head clinical trial for the treatment of glabellar lines. The trial showcased Daxxify’s longer duration of effect and presents a compelling option for patients seeking effective treatments for glabellar lines.

MA: Are there any drawbacks or limitations associated with Daxxify?

Dr. Cox: One notable challenge associated with introducing any new product to the market, including Daxxify, is the learning curve for physicians. Each neuromodulator product possesses distinct properties concerning action onset, field of effect, and duration. Dosing various anatomical areas can be complex due to considerations of muscle mass and the interplay of surrounding muscles. The art and science of neuromodulator treatments rely on a physician’s ability to assess individual anatomy and achieve optimal cosmetic outcomes. Until you have experience with a product it is difficult to extrapolate dosing to other non-FDA approved areas of the face. Personally, I have found it difficult to predict the duration of effect for any individual patient. With the median duration of six months that implies 50% of the patients get a 6-month-or-longer effect, but 50% get less than 6 months. Therefore, it is difficult to set duration expectations for my Daxxify patients.

Dr. Biesman: One notable consideration concerning Daxxify lies in setting realistic patient expectations regarding the duration of its effects and anticipated outcomes. Adequate communication and managing patient expectations become crucial factors to ensure a positive treatment experience and overall satisfaction with the product.

MA: Which specific patient profiles or characteristics make Daxxify a recommended treatment option in your practice?

Dr. Cox: I recommend Daxxify to patients who express concerns about the longevity of their current neuromodulator, particularly those experiencing a shorter duration of effect (around 2 to 3 months). Additionally, Daxxify may be suitable for patients seeking a twice-yearly treatment schedule, aligning better with their filler treatments or for those who travel from distant locations to my office. Moreover, individuals who are enthusiastic about exploring innovative treatments and those dissatisfied with their current regimen may also find Daxxify a compelling option.

Dr. Biesman: Daxxify is recommended for patients seeking a treatment option that offers potentially longer duration of effect. A thorough evaluation by a medical expert will ensure that Daxxify aligns appropriately with each patient’s unique needs and preferences.

MA: What has been the level of patient interest in Daxxify, and what factors contribute to either its popularity or potential areas of hesitation among patients?

Dr. Cox: Patients do want to know what is new in the cosmetic industry and are interested in the clinical trials we run in my office. Positive feedback from friends or compelling direct-to-consumer marketing from the company also pique their interest. Patients often want their results to last longer, and this product may help them achieve that. However, the main drawback is the premium cost associated with this product. We charge more for this product, positioning it as a premium product. As a physician this product costs me more to use and that cost is partially transferred to the patients. The other reasons people may not want to try the product is that they are happy with their current product and see no reason to change. They may want “actors dosing” so want a light treatment. Additionally, newcomers to neuromodulator treatments may be hesitant to opt for a longer-lasting product until they are more certain about their preferences.

Dr. Biesman: The response indicates a diverse range of patient attitudes toward Daxxify. Some individuals express great enthusiasm for exploring a new treatment option that potentially offers longer-lasting results, while others approach it more cautiously, considering a change from their current effective regimen. Patient interest varies based on individual preferences, priorities, and comfort levels with trying novel therapeutic approaches.

MA: Looking ahead, do you foresee an increase or decrease in your utilization of Daxxify within the next year? What factors might influence this trend?

Dr. Cox: In the coming year, I anticipate an increase in the usage of Daxxify as awareness spreads and more marketing efforts promote the product, leading to a higher number of patient inquiries and interest in trying it. Nonetheless, it is important to acknowledge that competition may arise from other products in the pipeline, offering similar longer-lasting effects. As these competing products become available, their presence may influence the dynamics of Daxxify’s utilization within the market.

Dr. Biesman: Considering the upward trajectory of patient experience with Daxxify, I anticipate a growing trend in its usage over the coming year. As more individuals gain familiarity with the product and share positive outcomes, it is likely to generate momentum, leading to increased adoption within the medical community. Achieving a critical mass of satisfied users is often pivotal in driving the acceptance and uptake of newer products or treatments in the market.

1. Daxxify. Prescribing information. Revance Therapeutics, Inc; 2022. Accessed July 22, 2023. https://revance.com/wp-content/themes/allen-larson-theme/files/daxi-pi-and-med-guide.pdf

2. Botox. Prescribing information. Allergan USA, Inc; 2021. Accessed July 22, 2023. https://www.rxabbvie.com/pdf/botox-cosmetic_pi.pdf

3. Nigam PK, Nigam A. Botulinum toxin. Indian J Dermatol. 2010;55(1):8-14. doi: 10.4103/0019-5154.60343 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2856357/

4. Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ. A large, open-label, phase 3 safety study of daxibotulinumtoxinA for injection in glabellar lines: a focus on safety from the SAKURA 3 study. Dermatol Surg. 2021;47(1):42-46. doi: 10.1097/DSS.0000000000002463 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752221/.