September 13, 2022
Source/Business Wire
Daxxify, a new anti-wrinkle drug, approved by the FDA is expected to rival Botox, which has dominated the market for decades. Its manufacturer, Revance Therapeutics, has not yet released pricing information. The drug is expected to hit the market in 2023.
Botox has dominated the anti-wrinkle product market for decades, but consumers soon will have an option that lasts twice as long as current treatments.
Daxxify, approved last week by the U.S. Food and Drug Administration, can be injected into the frown lines on the face to reduce the appearance of wrinkles – just like Botox. But because its effects can last for up to six months, rather than three, its is viewed as Botox's first major competitor in years.
Both products are neuromodulators – injections of botulinum toxin designed to treat wrinkles by relaxing the underlying muscles.
There only are a few neuromodulators available for people looking to defy the natural signs of aging: the drugs by Botox Cosmetic, Dysport, Xeomin and Jeuveau. Yet, Botox accounts for 70% of the market.
Now, Daxxify, developed by Revance Therapeutics, gives consumers a longer-lasting alternative option.
"Users do not have to go once every three months, Balaji Prasad, a specialty pharmaceuticals analyst for Barclays Investment Bank, told the New York Times. "In a world where time is of the essence, having a product with a long duration factor is extremely useful."
The treatment is expected to hit the market in 2023, but Revance has not yet announced pricing information.
In clinical trials, 80% of people using Daxxify had no or minimally visible facial wrinkles after four months, and almost half of participants still had very few wrinkles at six months. Some study participants were even seeing results after nine months.
Daxxify differs from other neuromodulators in other ways, too.
The other products are made from human serum albumin, the most abundant protein in human blood plasma, Dr. Nazanin Saedi, a dermatologist at Dermatology Associates of Plymouth Meeting and a professor at Thomas Jefferson University, told Everyday Health. Daxxify doesn't contain any human or animal products. Instead, it uses peptides, the building blocks of all living things. The peptides may help make Daxxify last longer than other products, dermatologists say.
And, unlike Botox and most other neuromodulators that require refrigeration, Daxxify can be stored at room temperature.
Daxxify is only approved to smooth frown lines, whereas Botox also is approved to treat other parts of the face, such as crow's feet and and the forehead. Botox also is approved to treat some types of urinary incontinence, neck muscle spasms and severe underarm sweating.
"Botox has so many indications besides aesthetic use, and I foresee that being the same for this new neuromodulator," Saedi told Everyday Health.
There were no serious side effects reported during the clinical trials, according to Revance. The most common side effects were headaches, which was experienced by 6% of study participants. About 2% reported drooping eyelids and 1% reported facial asymmetry.
Botulinum toxin is a poisonous substance that can cause botulism, a rare but serious illness that affects the body's nervous system. Botox was the first drug to utilize it.
Neuromodulators only use a very small amount of botulinum toxin, which does not show up in the bloodstream. The injections generally are considered safe when administered by an experienced doctor.
Possible side effects and complications include headache or flu-like symptoms, droopy eyelids or cockeyed eyebrows, a crooked smile or drooling, eye dryness and excessive tearing. More serious complications include muscle weakness, vision problems, difficulty speaking or swallowing, and loss of bladder control. People are advised to seek immediate medical attention if they experience any of these symptoms.
