Daxxify – What is the new Botox challenger capable of?

Daxxify – A challenger for Botox?

Daxxify goes live. Daxxify is a novel neuromodulator for cosmetic wrinkle treatment. Daxxify could become Botox’s first major competitor in decades, experts say. Why? Because Daxxify promises a significantly longer duration of action than previous Botox preparations. At least that is what the clinical studies indicate. The drug is not yet on the market, neither in the USA nor in Europe. However, it has already received approval in the USA, so market launch is expected shortly. Once it becomes available, perhaps as early as 2023, Daxxify could become a real game-changer.

In the following post, I take a closer look at Daxxify. These are the topics:

Botox: The most popular non-invasive treatment

6 million Botox applications annually

Botox has been the treatment of choice for wrinkle reduction for more than 20 years. Millions of people use it regularly. Today, it is still the most commonly performed non-invasive treatment in aesthetic medicine: according to industry estimates, it is injected more than 6 million times a year, 400,000 of them in Germany. Whether wrinkles on the forehead, crow’s feet around the eyes or an excessively pronounced frown line between the brows: Botox works quickly and reliably and gives a visibly fresher appearance. At a cost of a few hundred euros per treatment, it also offers great benefits at a relatively small price.

Vistabel, Dysport, Azzalure, Jeuveau

The original Botox from manufacturer Allergan, which is now marketed for cosmetic purposes under the name “Vistabel,” has largely retained its unique selling proposition. While there are some competitors, such as Dysport, Azzalure, Bocouture and Jeuveau, none of these preparations have been able to match the popularity of Botox. The latter Jeuveau, which launched in the U.S. three years ago with great fanfare, has not even made it to market in Europe yet. And the latest development of Azzalure, a liquid drug called Alluzience, focuses on a more effective way for physicians to administer it rather than a real added benefit for patients.

Daxxify – available as early as 2023?

Daxxify: Already approved in the U.S. for the treatment of glabella

If industry experts are to be believed, that could change with the upcoming launch of Daxxify. Daxxify, officially known as “Daxibotulinumtoxin A,” was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of frown lines (glabella) and has one key feature: a significantly longer duration of action than conventional Botox preparations. While this is usually 4-6 months, Daxxify promises its wrinkle-smoothing effects for a full 9 months.

Daxxify promises significantly longer duration of action

The advantage for the patient is thus obvious: instead of having to undergo the procedure two – or three times a year, Daxxify would ideally extend the treatment interval to twice that. Two treatments in 18 months instead of three in 12: that’s convincing, even if you don’t have a phobia of hypodermic needles. Not to mention the potential cost savings.

9 months duration of action in 10% of patients

In Phase III clinical trials, the manufacturer of Daxxify, the U.S. pharmaceutical company Revance Therapeutics, has tested the active ingredient in the treatment of glabella (frown lines) in around 2,700 patients. In 98% of the subjects, a significant improvement in the appearance of wrinkles was observed within four weeks after treatment. For 90%, this was already the case after the first week. The effect usually started within two days after treatment and lasted for an average of six months. In about 10% of patients, the results were still visible nine months later.

Side effect profile of Daxxify comparable to current preparations

Side effects of Daxxify injection occurred in about one in five subjects. The most common side effects were headache, injection site pain, erythema and edema at the injection site, and drooping eyelids (ptosis). The type and frequency of side effects are thus roughly on a par with conventional Botox preparations. In addition, interestingly, none of the subjects developed neutralizing antibodies to Daxxify, even though it was administered in up to 3 consecutive treatments. This is also consistent with previous findings on the various botulinum preparations. And gives reason to believe that even with Daxxify, lack of efficacy due to resistance is to be expected only in very rare cases.

Micro-Botox Munich, Dr. med. Eva Maria Strobl

How does Daxxify work?

Daxxify inhibits the transmission of stimuli from the nerve to the muscle

Like conventional Botox products, Daxxify is an acetylcholine inhibitor. After injection, it inhibits the transmission of stimuli between nerve and muscle by preventing the release of the neurotransmitter acetylcholine. The wrinkle-forming muscles are thus inhibited in their contraction. They relax, which visibly improves the appearance of wrinkles in the overlying skin. In the current FDA-approved application for the treatment of frown lines, this predominantly affects the corrugator as well as the procerus muscle, which together are causative for the formation of the frown line.

Daxxify does not contain human or animal protein

Unlike conventional Botox preparations, Daxxify does not contain human or animal proteins derived from blood(albumins) to stabilize the neurotoxin. Instead, Daxxify uses a peptide, a small protein building block consisting of a concatenation of several amino acids. This specially designed peptide, called RTP004, is thought to help deliver botulinum toxin to nerve cells. Research suggests that the RTP004 binds the toxin to nerves near the injection site, possibly causing the prolonged effect. According to the manufacturer Revance, the absence of human and animal blood components is the real innovation in the production of neurotoxin preparations for wrinkle treatment. The peptide technology is proprietary, so other manufacturers cannot easily copy it and adapt it to their own Botox preparations.

Can wrinkles other than glabella be treated with Daxxify?

Currently, the drug is only approved in the USA for the treatment of frown lines. However, presentations by the manufacturer Revance indicate that approval for further cosmetic applications, and possibly later also for non-cosmetic therapies, such as in neurology, is definitely intended. In this respect, Daxxify would follow a similar trajectory to the original Botox, whose cosmetic use was also limited to glabella treatment only for a number of years. Officially, at least, because unofficially, in “off-label use”, all kinds of mimic wrinkles were treated by doctors all over the world, long before the extended approval for it was granted. So if Daxxify proves itself in the treatment of the glabella and proves to be safe, then practitioners will foreseeably use it quite rapidly in off-label use in other cosmetic applications as well.

What are the contraindications of Daxxify

The contraindications of Daxxify are the same as for conventional Botox preparations, according to the American package insert. Intolerances with regard to the ingredients, the presence of certain neurological disorders, and concurrent medications with a number of active ingredients are the most important reasons for exclusion. In addition, pregnancy and lactation.

How much will the new Daxxify cost?

Prices for the new Daxxify have not yet been announced. If the longer duration of action is confirmed in practice, it can be assumed that the manufacturer Revance will want to pay for this. However, recent experience with Botox challenger Jeuveau showed that without price advantages, it is difficult for new entrants to succeed against the market leader Allergan and its classic.
In this respect, there is the prospect that Daxxify patients will end up saving money by having to have booster treatments less often.

Attractive at every age

LIPS and SKIN Aesthetic Medicine

Eva Maria Strobl, MD
Herzog-Heinrich-Strasse 34
80336 Munich