F.D.A. OKs Daxxify, an Anti-Wrinkle Drug and Botox Competitor

The Food and Drug Administration has approved a new drug that reduces the appearance of facialwrinkles for about six months, spurring competition in a market that for decades has been dominated byotulinumtoxinA.

The approval of the Daxxify treatment by Revance was announced on Thursday morning.

The new treatment is called a neuromuscular blocking agent, and it is similar to the one used to treatotulinumtoxinA. Botulinum toxin is not detected in the patient's bloodstream when used as directed.

In studies submitted to the F.D.A., the treatment far exceeded the effect of a placebo, with about 80 percent of the treatment providers seeing no or mild facial lines after four months.

The medication was the most significant advancement in the $3 billion field of facial injection drugs since the first one was approved decades ago, according to Dr. Balaji Prasad.

Users don't have to go once a month. A long duration product is very useful in a world where time is of the essence.

The chief executive of Revance said in an interview on Thursday that the company spent a lot of time trying to find an effective neuromuscular blocking agent that could be applied to the skin without a needle. It was able to keep the formula stable with the use of peptide technology, instead of using animal or human components. He said the company has begun to test for a variety of medical concerns.

The door is open for what we can do with the drugs. There is a huge medical opportunity if you think of headaches, incontinence, and other conditions.

In 2010 the F.D.A. approved the use ofotulinumtoxinA for chronic headaches.

A study submitted to the F.D.A. found that users of Daxxify experienced more side effects than those who took a placebo.

The F.D.A. warned of the potential for general muscle weakness or breathing difficulties with the use of toxin based treatments, but said no such symptoms were noted with Daxxify.

The drug was not easy to approve. The F.D.A. put off an inspection of the manufacturing site because of the travel restrictions imposed during the coronaviruses epidemic.

In June 2021, the F.D.A. discovered problems with the company's quality control process and working cell bank, agency records show. The company got a new working cell bank and that was the end of the issues.