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Health And Medical

FDA Approves Botox Competitor That Lasts Longer

By Cara Murez and Robin Foster HealthDay Reporters

HealthDay Reporter

FRIDAY, Sept. 9, 2022 (HealthDay News) — People attempting to keep wrinkles away will soon have a fresh option given that the U.S. Food and Drug Administration has approved the initial competitor for Botox in decades.

Daxxify, created by Revance Therapeutics Inc. in Nashville, Tenn., is injected in to the face along worry lines. It lasts longer than Botox, with about 80% of users seeing no or mild creases at four months after injection. For 1 / 2 of users, the procedure lasted half a year, the business said in a statement.

Users don’t need to go once every 90 days, Dr. Balaji Prasad, who covers specialty pharmaceuticals being an analyst for Barclays Investment Bank, told the NY Times. In a global where time is of the essence, having something with an extended duration factor is incredibly useful.

The brand new drug now enters the $3 billion field of facial injection drugs. Additionally it is a neuromuscular blocking agent and a botulinum toxin, like Abbvies Botox.

In addition, it opens up the entranceway for what we are able to do with therapeutics, said Revance CEO Mark Foley, told the Times. If you believe of migraines, cervical dystonia [a neurological condition that affects the muscles in the neck and shoulders], overactive bladder, theres an enormous medical opportunity aswell.

The business has begun testing the drug on these other medical issues, Foley said. As the company have been attempting to develop a product that needed no needle, it instead discovered a method to use peptide technology to help keep the merchandise stable. Typically, animal protein or human serum can be used.

Botox can be used for a lot more than just wrinkles. It’s been an FDA-approved treatment for chronic migraines since 2010.

Users of Daxxify in the Revance studies included some who experienced unwanted effects. About 2% of individuals developed a drooping eyelid, while about 6% experienced headache, the business said.

Toxin-based treatment can carry the prospect of other unwanted effects, such as for example general muscle weakness or breathing difficulties, the FDA cautioned. Daxxify study participants showed none of these symptoms.

Revance had initially wished for approval of its product in November 2020, but plans were postponed due to pandemic travel restrictions, the Times reported. An inspection finally conducted in June 2021 found issues with the product quality control process and the companys working cell bank, that have the drugs active component. Those concerns were resolved, the Times reported.

More info

The National Library of Medicine has more about botulinum toxin.

SOURCE: NY Times

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