Anti-wrinkle injection that lasts two months longer than Botox approved by the FDA –

An injectable wrinkle treatment that lasts about two months longer than Botox has been greenlit for adult use by the Food and Drug Administration (FDA), making it the first of its kind to receive approval in more than a decade.

Daxxify by Revance is injected into face and eye care lines. It lasts about six months, surpassing its main competitor Botox in three to four months.

Mark Foley, CEO of the Tennessee-based biotech company, said he was already investigating whether it could also be used to treat lip cramps and cervical dystonia when neck muscles contract involuntarily. Daxxify found it while searching for a cream that could slow down wrinkles.

Every year, more Americans are signing up for injections 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.

Daxxify works similarly to Botox, a neuromuscular blocking agent that effectively freezes the muscles and helps prevent wrinkles.

The developers hope to encourage more people to switch to treatment as fewer injections are required each year.

Botox clients typically require at least three injections per year, but with Daxxify this can be reduced to two with the same treatment effects.

A price has yet to be announced for the new treatment, but the main competitor typically costs between $250 and $500 per injection in each treatment area.

Foley said they plan to distribute them to a few select pharmacies whose locations have not been disclosed at first, for use on only a few patients.

It will then be commercially available.

Daxxify is the first treatment to use peptides instead of the animal or human proteins typically used to keep the formula stable.

The FDA announced that the treatment has been approved for use in adults on a list of innovative drugs released this week.

Approval was based on phase 3 studies involving 2,700 patients and more than 4,200 injections.

The results showed that 74% of the subjects had an improvement in their lines after four weeks of treatment.

It took an average of six months: Some patients said it was still working nine months later.

The most common side effect of treatment was headache (affecting 6% of participants), followed by drooping of the eyelids (2%).

No one had muscle weakness or difficulty breathing, but the FDA warned that this can still happen when the treatment is used.

Pictured is company CEO Mark Foley

Foley said Daxxify will be a “disruptive innovation” and the culmination of “years of pioneering research and development”.

The product has been waiting for the green light for a long time and the first inspection scheduled for November 2020 has been postponed due to the Covid pandemic.

In June of the following year, the FDA conducted the review and found issues with the company’s quality control process and functioning cell bank or cells containing the active substance.

This was fixed only after the cell bank was changed this year.

Botox has been available in the United States since 1989 and now brings in about $4.7 billion a year in fighting wrinkles.

Its value is only expected to increase in an aging population, but businessmen hope Daxxify can break its dominance in the market.