From: Aesthetic Insights
Nov 14, 2023
KOLs Reveal Reality of Long-Lasting Neurotoxins
Longer-lasting cosmetic neurotoxin duration has greatly interested practitioners since the roll-out of DAXXIFY (Revance Therapeutics, Inc., Nashville, Tenn.), which claims a notable six-month efficacy period. Other manufacturers have been researching and substantiating extended-duration formulations and dosages of their products to compete with DAXXIFY. One leading company in our industry showcased its most recent findings from such research at the American Society for Dermatologic Surgery (ASDS) annual meeting. Evolus, Inc. (Irvine, Calif.), presented phase 2 trial results for an “extra strength” 40-unit formulation of Jeuveau, demonstrating efficacy up to 26 weeks in treating glabellar lines.
“Dosing is a topic that has come up frequently from injectors around the country,” stated David Moatazedi, Evolus President and CEO. “Around two years ago we entered into a large phase 2 study in order to show how 40 units, which we call extra-strength Jeuveau, performs if we followed patients out for a full six months.”
The double-blind study’s aim was to look at the safety and duration of effect of Jeuveau at an increased dose to treat moderate to severe glabellar lines. “With 150 patients divided into three arms, we investigated an extra-strength, hyper-concentrated 40-unit dose of Jeuveau compared to the standard 20-unit doses of Jeuveau and BOTOX in the glabellar region, using the 4-point Glabellar Line Scale, or GLS,” said Rui Avelar, M.D., Head of Research and Development and Chief Medical Officer at Evolus. “The study spanned one year or until the treatment’s effects subsided, a method allowing for straightforward cross-toxin comparisons independent of various scales.”
The findings revealed that the median effect of Jeuveau’s 40-unit dose lasted six months, or 183 days, or 26.1 weeks, as determined by Kaplan-Meier analysis and confirmed by global aesthetic improvement assessments. Patients maintained at least a one-point improvement on the GLS and consistent results on the Global Aesthetic Improvement Scale. “Safety evaluations showed no significant differences in adverse events among the groups, with 89% classified as mild and one moderate, indicating a clean safety profile comparable to the standard doses,” added Dr. Avelar. “Overall, the extra-strength Jeuveau demonstrated a statistically significant increase in duration of effect, up to six months when compared to the active controls, aligning with the expected increase in duration with higher toxin doses.”
Evolus is just one of several developers reformulating their neurotoxins to be longer lasting. “We’ve seen what other toxins, including DAXXIFY and BOTOX, can do at 20 units. When you double the dose, you get longer duration,” said Sue Ellen Cox, M.D., FAAD, dermatologist and Past President of the ASDS. “It’s not a linear correlation. Doubling the dose doesn’t give you double the duration. It’s about 30%, maybe 40% depending on what study you look at. And that’s the reality behind the claims about longer-lasting neurotoxins.”
While Evolus and other neurotoxin competitors are busy validating long-lasting formulations, Revance has been trying to improve performance of another kind, namely to roll back pricing and market perceptions of DAXXIFY. Initially, Revance set DAXXIFY’s price-per-unit higher than other botulinum toxin injectables because of the longer, more effective results. The company claimed DAXXIFY has double the longevity of BOTOX, aiming to penetrate the “prestige market” despite its higher cost. However, DAXXIFY has seen limited success in overtaking BOTOX since its approval. In response, Revance unveiled a revised strategy in September 2023, a price reduction to boost market share and sales.
“The buzz around the ASDS meeting was that the price reduction will probably boost Revance’s bottom line,” said Michael B. Gold, M.D., FAAD, founder and medical director of Gold Skin Care Center (Nashville, Tenn.). “That may be, but the elephant in the room with DAXXIFY has always been the marketing message, which is its neurotoxin can last six months. However, not 100% of the patients get that six-month duration. It’s a smaller percentage. Some people get maybe six. I’ve seen it last nine months with one of my best friends. The company’s messaging needs to align with what’s real, and what’s happening in clinics. I think it’s a great toxin. But as physicians, we always want to under promise and over deliver.”
Jeremy B. Green, M.D., dermatologist and principal investigator at the Skin Research Institute in South Florida (Coral Gables, Fla.), agreed. “One challenge for injectors is Revance’s messaging, that DAXXIFY lasts six months. It can last six months in glabellar lines, for sure. I was an investigator in the clinical trial, so I saw that with my own eyes. But when patients hear six months, they don’t distinguish between frown lines and other areas. Some people think it will last six months in forehead lines. I’ve seen nothing last six months on the forehead. But they hear the messaging from the company, and physicians have to spend time explaining to patients and setting them straight. Another challenge is the cost. DAXXIFY has been more costly for us, and then subsequently for patients. I’m happy to hear of some cost adjustments being planned, but there’s an expression, you never get a second chance to make a first impression. All that said, I think that there’s hope for DAXXIFY. I think it can gain traction and realize its potential in the market.”
