FDA Approves Botox Competitor That Lasts Longer

FRIDAY, Sept. 9, 2022 (HealthDay News) — People trying to keep wrinkles at bay will soon have a new option after the U.S. Food and Drug Administration approved Botox’s first competitor in decades.

Daxxify, manufactured by Revance Therapeutics Inc. of Nashville, Tennessee, is injected into the face along worry lines. It lasts longer than Botox, with around 80% of users seeing little or no facial wrinkles four months after the injection. Half of the users were treated for six months, the company said in a statement.

“Users don’t have to go every three months,” said Dr. Balaji Prasad, who is an analyst covering specialty pharmaceuticals for Barclays Investment Bank New York Times. “In a world where time is of the essence, having a product with a long lifespan factor is extremely useful.”

The new drug is now breaking into the $3 billion facial injection drug space. It is also a neuromuscular blocking agent and a botulinum toxin, like Abbvie’s Botox.

“It also opens the door to what we can do with therapeutics,” Revance CEO Mark Foley told Times. “If you think of migraines, cervical dystonia [a neurological condition that affects the muscles in the neck and shoulders]overactive bladder, there is also a great medical opportunity.

The company has begun testing the drug for these other medical issues, Foley said. While the company had been trying to create a product that didn’t require a needle, they instead discovered a way to use peptide technology to keep the product stable. Typically, animal protein or human serum is used.

Botox is also used for more than just wrinkles. It has been an FDA-approved treatment for chronic migraines since 2010.

Among the users of Daxxify in the Revance studies were some who experienced side effects. About 2% of people developed a droopy eyelid, while about 6% experienced headaches, the company said.

A toxin-based treatment may have the potential for other side effects, such as general muscle weakness or difficulty breathing, the FDA warned. Participants in the Daxxify study showed none of these symptoms.

Revance initially hoped for approval of its product in November 2020, but plans have been delayed due to pandemic-related travel restrictions Times reported. A final inspection, conducted in June 2021, revealed issues with the company’s quality control process and functioning cell bank containing the drug’s active ingredient. Those concerns were allayed Times reported.

More information

The National Library of Medicine has more on botulinum toxin.