DAXXIFY ANTI-WRINKLE DRUG: THE NEW BOTOX ALTERNATIVE

What is the new Botox Alternative?

This big question has been gathering steam in the field of cosmetic care recently.

Daxibotulinumtoxin A, commercially known as Daxxify, is a new FDA-approved anti-wrinkle treatment developed by Revance Therapeutics.

Unlike other neuromodulators, Daxxify is a long-lasting peptide-formulated product.

Most Botulinum toxin type A (BoNTA) injections, such as Botox, produce cosmetic effects that last around 3-4 months. Alternatively, a Daxxify treatment lasts up to 6 months on average and can last up to 9 months in some patients. 

Continue reading to learn more about Botox’s new rival, “Daxxify”, how it works, how effective it is, and how it’s different from other anti-wrinkle injections, including Botox.   

What Are Botulinum Toxins?

Botulinum toxin is a biological neurotoxin produced by the bacteria “Clostridium botulinum.” A Botulinum toxin injection blocks the neural signals that cause muscle contraction and temporarily weakens or paralyzes the injected muscle.

Two types of Botulinum toxins are now widely used to treat medical and cosmetic conditions in humans; Botulinum toxin types A and B.

Botulinum toxin type B injections are generally used to manage the symptoms of medical conditions, such as:

• Crossed eyes (strabismus)
• Involuntary muscle twitching in the face, jaw, neck, hands, or feet (focal dystonias)
• Involuntary muscle twitching on one side of the face (hemifacial spasm)
• Migraines
• Excessive saliva production (hypersalivation)

Alternatively, Botulinum toxin type A (BoNTA) injections are mostly used for cosmetic purposes to reduce the appearance of wrinkles and fine lines.

In 2002, the FDA approved the cosmetic use of Botox (Botulinum toxin-A), manufactured by Allergan, for temporarily treating forehead frown lines and wrinkles.   

Anti-wrinkle injections with Botulinum toxin can temporarily reduce or eliminate wrinkles and lines all over the face, chin, neck, and chest. The most commonly treated areas by Botox injections are frown lines between the eyes, crow’s feet near the eyes, and forehead wrinkles. 

What Is Daxxify?

Daxxify, or DaxibotulinumtoxinA, is a new Botulinum toxin type A (BoNTA) product manufactured by Revance Therapeutics (a biotechnology company).

On September 8, 2022, the U.S Food and Drug Administration (FDA) approved the cosmetic use of Daxxify injections to treat glabellar forehead frown lines[1]  (the vertical frown lines between the eyes). The FDA approval of Revance’s Daxxify labeled it as the new botox alternative of 2022.

The new Daxxify product from Revance contains a highly purified form of the Botulinum neurotoxin weighing 150 kilodaltons (kDa). 

Neuromodulators, such as Botox, are usually formulated with human serum albumin as an excipient. An excipient is a pharmacological ingredient added to improve certain qualities of the drug, such as its stability and delivery. 

Daxxify is the first neuromodulator formulated with peptide exchange technology that uses a stabilizing peptide (RTP004) as an excipient instead of human serum albumin (HSA).  

The RTP004 peptide enhances the binding of the Botulinum neurotoxin to nerve endings, which makes its cosmetic effects last longer.  

How Does Daxxify Work?

Similarly to other Botulinum neurotoxins, Daxxify interferes with the neural transmission that causes muscle contraction; it blocks the signal from the nerves to the muscles. 

Several types of wrinkles are caused by the contraction of muscles attached to the overlying skin. The more strained the muscles are, the deeper the wrinkles.

The injection of Daxxify blocks the release of acetylcholine, a neurotransmitter essential for muscle contraction, from presynaptic neurons.

When the facial muscles do not receive a message from the acetylcholine neurotransmitter, they cannot contract and remain relaxed. 

The weakening or paralysis of the muscles relieves the strain on the overlying facial skin. Consequently, the skin becomes smoother, and the wrinkles and frown lines flatten out. 

Clinical Evidence Supporting Daxxify

A large Phase 3 SAKURA clinical study evaluated the safety and efficacy of anti-wrinkle Daxxify injections in treating glabellar frown lines. The study included 2,691 participants who received a total of 3,830 Daxxify treatments.   

The study showed the following outcomes:

• More than 90% of participants had less visible wrinkles only one week after a Daxxify treatment.
• One month after treatment, almost 98% of all patients had little to no wrinkles.
• Three months after treatment with Daxxify, more than 80% of participants were still wrinkle-free.
• Half of the participants had minimal wrinkles and frown lines six months after a Daxxify injection.
• Some patients also had results that lasted up to 9 months (36 weeks). 

Additionally, none of the participants developed neutralizing antibodies to Daxxify. That means the body’s immune system did not identify the injected drug as a threat and did not produce antibodies to fight it.  

The authors concluded that the new DaxibotulinumtoxinA (Daxxify) is well-tolerated in patients and is highly effective against wrinkles. Moreover, the cosmetic benefits of Daxxify lasted, on average, around six months following a single treatment.

Therefore, Revance’s Daxxify was proven effective and safe for use as a new anti-wrinkle treatment with more durable results than other anti-wrinkle injections.

What Are The Side Effects Of Daxxify?

According to the SAKURA clinical trials and Revance’s announcement, researchers did not observe any dangerous side effects due to Daxxify injections. 

In the SAKURA clinical trials, 17.8% of the 2,692 participants had Daxxify treatment-related side effects similar to those of other neuromodulators, including Botox. 

The most common side effects observed in the clinical trials after a Daxxify treatment included:

• Headache (4.6% - 6%)
• Pain at the site of injection (3.6%)
• Redness at the site of injection/ erythema (3%)
• Swelling at the site of injection/ edema (2.8%)
• Drooping in the upper eyelid/ eyelid ptosis (1.3% - 2%)
• Inability to move the muscles of the face on one or both sides/ facial paresis (1%)

How Is Daxxify Different Than Botox?

After receiving FDA approval, Revance now offers a new wrinkle treatment other than Botox.

There are a lot of similarities between Daxxify and Botox, such as:

• Both Daxxify and Botox contain the Botulinum neurotoxin derived from the Hall strain of Clostridium botulinum.
• They both work by blocking acetylcholine release and temporarily paralyzing the muscle.
• Similarly to Botox injections, Daxxify injections can temporarily reduce or eliminate facial wrinkles, lines, and creases. 

But what are the differences between Botox and Revance’s Daxxify?

• The major difference between Daxxify and other BoNTA products is durability. Daxxify injections last longer than Botox injections. The anti-wrinkle effects of Botox last between 3-4 months, whereas Daxxify’s can last up to 6 months, and sometimes more. That makes Daxxify a more durable alternative to Botox. 
• Unlike Botox, Daxxify doesn’t contain Human Serum Albumin (HSA). Instead, it’s the only neuromodulator formulated with peptides that improve its stability after injection.
• Daxxify can be stored at room temperature and does not require refrigeration, unlike Botox.
• Daxxify is FDA-approved only to treat frown lines between the eyes. On the other hand, Botox is also FDA-approved to treat crow's feet and forehead lines, in addition to several medical conditions. However, doctors can prescribe Daxxify for “off-label” purposes not yet approved by the FDA. 

Is Daxxify Cheaper Than Botox?

It’s still unclear how much a Daxxify injection will cost - Revance still hasn’t released pricing information for its new product.

Nonetheless, determining whether Daxxify is more cost-effective than Botox isn’t just about the price of an injection. Botox injections can last between 3-4 months. As a result, patients will have to get new injections every 3-4 months, which adds up to around 3-4 doctor visits per year.

In contrast, Daxxify injections can last up to six months or more. Consequently, patients will generally need only two injections per year instead of three or four.

Depending on the price of a single injection of Daxxify, you’ll be able to estimate whether it’ll be cheaper to go with Botox or Daxxify anti-wrinkle injections.

So when will Daxxify be available? Revance’s new anti-wrinkle treatment is expected to become widely available in the U.S starting in 2023. 

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Sources:

• BOTULINUM TOXIN - PMC
• Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A
• Botulinum Toxin - StatPearls - NCBI Bookshelf
• DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

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