By Rich Haridy
September 12, 2022
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Clinical trials found a single treatment with a novel
formulation lasted up to nine months (Photo credit: Revance Therapeutics
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For several decades one of the most common cosmetic
procedures has involved injecting small volumes of the botulinum toxin into
parts of the face. The toxin is a neuromuscular blocking agent, paralyzing
certain facial muscles, leading to a smoothing of the skin and a reduction in
wrinkles.
The most common brand of treatment is the familiar Botox,
however, several other companies have come up with their own competing botulinum
formulations over the years. Despite these competitors, Botox has basically
dominated the anti-wrinkle market for decades, with no significant innovation
in the biotech world of anti-wrinkle treatment.
The development of Daxxify took years, and was originally
focused on producing a Botox-like anti-wrinkle treatment that didn’t need to be
injected. As the research team at Revance Therapeutics explored different ways
to stabilize the toxin molecules they developed a novel peptide technology that
unexpectedly enhanced the duration of the treatment.
A Phase 3 human trial, involving nearly 3,000 participants,
found Daxxify was effective at reducing wrinkles but lasted much longer than
current treatments. The effects of Botox injections generally begin to wear off
after around three months but the clinical trial found Daxxify lasted at least
six months, and in some patients up to nine months.
Daxxify was originally ready for FDA approval back in 2020
but a combination of pandemic delays and quality control issues at the
company’s production factory led to a long pause on its final authorization.
Mark Foley, CEO of Revance, said to Fierce Pharma the plan is for a slow roll-out over the
rest of the year as the product is delivered to a group of select physicians
before it is made more widely accessible in 2023.
“It’s been a long journey to get here,” added Foley. “We’re
super excited because it will be the first time in over 30 years that a truly
innovative neurotoxin has been brought to the market.”
And just as Botox is used in a variety of clinical
contexts, the company is exploring how Daxxify could treat several medical
issues, including migraines, muscle spasticity and even overactive bladder.
Source: Revance Therapeutics