Daxxify, a New Anti-Wrinkle Drug and Botox Competitor is FDA-Approved

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin.

With age, faces can undergo a variety of changes from the various expressions made over the years and daily use of facial muscles. Many people choose to undergo non-invasive cosmetic procedures to prevent or reduce the appearance of signs of aging. One of the first options made available for such purposes was Botox from Allergan, brought to health practitioners’ offices in 1989. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles. By reducing the movement of these muscles, wrinkles become less pronounced over time. These properties of Botox can also be used to treat conditions like neck muscle spasms, excessive sweating and jaw clenching that results in migraines.

Revance recently announced in a press release that the FDA had approved their novel neuromodulator Daxxify (DaxibotulinumtoxinA-lanm) for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. The product has been approved for use in adult patients for the temporary improvement of moderate to severe glabellar (frown) lines.

The approval of Daxxify brings disruptive innovation to the aesthetics industry, which has remained unchanged for over 30 years in the case of neuromodulator products. Daxxify is the first and only peptide-formulated neuromodulator with long-lasting results, powered by Revance’s Peptide Exchange Technology. Daxxify is effective, as safe as competitors, and has been well tolerated in clinical trials.

A Novel Botox Competitor

What separates Daxxify from competitor products is the fact that the effects last an average of six months after injection, and last up to nine months in some patients. As a result, patients can achieve year-long aesthetic results with only two treatments per year. This property of Daxxify addresses the largest unmet need with existing neuromodulating injections, which is their lasting power.

The approval of Daxxify was based on data generated in a series of clinical trials, the SAKURA Phase III clinical trial program (1, 2 and 3). In fact, the SAKURA study is the largest Phase III clinical ever conducted for the cosmetic treatment of glabellar lines, involving over 2700 patients and around 4200 treatments.

The studies successfully demonstrated that Daxxify was well tolerated by patients, resulted in clinically significant improvement and longer lasting results (two months longer than conventional neuromodulators) and patients expressed high levels of satisfaction, all while using the small amount of 0.18 ng of the core active ingredient.

Overall, 74 percent of patients achieved greater than or equal to two-grade improvement in their glabellar lines at four weeks post-treatment, based on assessment performed by both investigators and the patient. Eighty-eight percent of patients achieved greater than or equal to two-grade improvement at four weeks post-treatment based on investigator assessment alone, and 98 percent of patients achieved none or mild wrinkle severity at four weeks based on investigator assessments. Additionally, results were seen as early as one day after treatment was administered, with most being noticeable within two days of treatment.

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Bringing Daxxify into Offices

In the clinical trials performed, Daxxify was found to be generally safe and well tolerated, giving it a similar safety profile to currently used cosmetic injectables. Common side effects experienced by patients were headaches, eyelid ptosis (drooping) and facial paresis or asymmetry. Ultimately, Daxxify can safely provide long-lasting results for patients for approximately six months, with as few as two treatments per year — compared to the three to four months of results achieved by competitor products.

In terms of bringing Daxxify to physicians and patients, CEO Mark Foley states that they “want to get [DAXXIFY] in the hands of a small group of physicians that can use this product to understand how to get the best results.” The company will be giving a small group of injectors the opportunity to gain experience with the product with early training and education programs at their headquarters and experience center in Nashville, before broad commercial launch.

Additionally, Revance will continue research with Daxxify in therapeutic areas — the company already has an FDA approval submission planned for the treatment of cervical dystonia, or neck spasms. A Phase II study has been completed for the treatment of upper limb spasticity with the injection as well.