Anti-wrinkle injection that lasts two months longer than Botox approved by FDA
Is this the end of Botox? Anti-wrinkle injection that lasts two months longer than its popular alternative gets green light from regulators at the Food and Drug Administration
- Daxxify is injected into care lines on the face and around the eyes to prevent wrinkles from appearing or getting stronger
- It works the same way as Botox and helps the muscles stop moving
- But the company says it will last about six months, compared to the three to four months for its main competitor Botox
- Research has begun to see if it can treat lip cramps and cervical dystonia — or when neck muscles contract involuntarily
An injectable anti-wrinkle treatment that lasts about two months longer than Botox has been given the green light for use in adults by the Food and Drug Administration (FDA) — becoming the first of its kind to receive approval in more than a decade.
Daxxify – manufactured by Revance – is injected into care lines on the face and around the eyes. It lasts about six months, surpassing the three to four months for its main competitor Botox.
Mark Foley, CEO of the Tennessee-based biotechnology company, said it is already investigating whether it could also be used to treat lip cramps and cervical dystonia — when neck muscles contract involuntarily. Daxxify came across it while researching a cream that could slow down wrinkles.
More and more Americans are signing up for injections each year to slow aging — with a current market value of $3.2 billion. But scientists warn of side effects such as drooping eyelids, muscle weakness and difficulty swallowing.
Pictured above are vials of the drug Daxxify, manufactured by a company in Nashville, Tennessee. It is approved for use by the Food and Drug Administration
Daxxify works similarly to Botox, a neuromuscular blocking agent that effectively freezes muscles and helps prevent wrinkles.
The developers hope to encourage more people to switch to the treatment as fewer injections are needed each year.
Botox clients generally require a minimum of three injections per year, but with Daxxify, this can be reduced to two with the same treatment effects.
What Are the Risks of Getting Botox?
More than 1.5 million Americans receive Botox injections each year to slow aging.
But the FDA says there are several risks with the injections that can flare up within hours, days, or weeks of getting the liquid.
- Difficulty swallowing;
- Loss of strength and muscle weakness over the body;
- double vision;
- Blurred vision and drooping eyelids;
- Hoarseness or change or loss of voice;
- Difficulty saying words clearly;
- Loss of bladder control;
- Problems with breathing.
A price for the new treatment has yet to be announced, but the main competitor typically costs between $250 and $500 per injection in each treatment area.
Foley said they plan to roll it out first to a select few pharmacies, whose locations have not been disclosed, for use in only a few patients.
It will then be made commercially available.
Daxxify is the first treatment to use peptides to keep the formula stable, rather than the animal or human proteins typically used.
The FDA revealed that the treatment had been approved for use in adults in a list of innovative drugs published this week.
Its approval was based on Phase 3 studies involving 2,700 patients and more than 4,200 injections.
The results showed that 74 percent of subjects had an improvement in lines four weeks after treatment.
It lasted an average of six months — some patients said it was still working nine months later.
The most common side effect of the treatment was headache (which affected six percent of participants), followed by drooping eyelid (two percent).
No one suffered from muscle weakness or breathing difficulties, but the FDA warned that this could still happen when the treatment is used.
Pictured is company CEO Mark Foley
Foley said Daxxify would be a “disruptive innovation” and the culmination of “years of pioneering research and development.”
The product has been waiting for a green light for a long time, and the first inspection scheduled for November 2020 has been delayed due to the Covid pandemic.
In June of the following year, the FDA conducted the inspection and found problems with the company’s quality control process and the working cell bank — or cells that contain the active ingredient.
This was only resolved this year, after the cell bank was replaced.
Botox has been available in the United States since 1989 and now brings in about $4.7 billion annually in the fight against wrinkles.
Its value is only expected to grow amid an aging population, but businessmen hope Daxxify can disrupt its market dominance.