US regulatory agency approves anti-wrinkle injection competing with Botox

The US regulatory agency, the Food and Drug Administration (FDA), last week approved the product Daxxify, a drug that promises to minimize the appearance of facial wrinkles. The drug is an alternative to Botox and a competitor.

The content appears in injectable form and was developed by the manufacturer Revance Therapeutics.

The treatment, approved on September 7, works as a neuromuscular blocking agent that “freezes” wrinkles.

According to the company, the neuromodulator can temporarily attenuate “moderate to severe frown lines” in adults for an average duration of six months.

He uses a toxin called botulinum, which works by blocking the release of the neurotransmitter acetylcholine. If the muscle is not able to receive the acetylcholine, it does not contract – in this way, the injection can “paralyze” the muscle, causing the information transmitted by the acetylcholine not to reach the muscle.

Now the drug appears as a competitor to Botox, approved in the US for therapeutic use since 1989 and later consolidated for the treatment of moderate to severe expression lines.

20 years ago, the regulatory agency approved Botox as a temporary wrinkle cosmetic – the first to be marketed for this use.

Daxxify results

The drug development study program was based on use by more than 2,700 patients and approximately 4,200 treatments.

In the pivotal trials, the results showed that 74% of subjects achieved an improvement by the fourth week of use. 98% of subjects achieved no or mild wrinkle severity after one month.

According to the company, results were seen one day after treatment, typically seen in two days, and some patients maintained treatment results for nine months.

“The most common adverse events related to treatment with Daxxify were headache (6%), eyelid ptosis or drooping eyelid (2%) and facial paresis, including facial asymmetry (1%).

Jeffrey Dover, an investigator for the program that initiated trials of the drug, said in a statement that he “is pleased to see the drug now approved as the first and only peptide-formulated long-acting neuromodulator on the market,” he said.