FDA Approves BOTOX Cosmetic for Third Indication


After previous indications in 2002 and 2013, the drug received its third indication for temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity

OnabotulinumtoxinA (BOTOX Cosmetic, Allergan plc) was approved for its third indication, for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity, the US Food and Drug Administration (FDA) announced.

The neurotoxin is the only therapy in its brand category to have received approval for aesthetic indications beyond glabellar lines in the United States.

"Allergan recognizes that forehead lines are a top area of concern for patients," David Nicholson, the chief research and development officer at Allergan, said in a statement. "Our goal in pursuing a third indication for BOTOX Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes."

The treatment was previously approved to temporarily improve the appearance of moderate to severe glabellar lines in 2002 and received its second indication for the temporary improvement of the appearance of moderate to severe crow’s feet lines in 2013.

The decision was made based on data from 2 clinical trials where the therapy was compared to placebo over the course of 30 days. The first trial revealed that 61% of subjects met the primary endpoint compared to 0% in the placebo group, and the second trial saw 41% of the subjects meet the primary endpoint compared to 1% in the placebo group.

OnabotulinumtoxinA is approved for use in more than 75 countries, and its safety and efficacy have been examined in almost 500-peer-reviewed articles, according to Allergan. Although it is the current market leader, other drugs in the pipeline are adding to the list of neurotoxin treatment options.

Recently, a neurotoxin alternative to BOTOX gained possible consideration for utility outside of cosmetic purposes, as well. Botulinum neurotoxin serotype E (EB-001) is just one injection treatment receiving consideration for pain therapy indication in phase 2 trials.

The neurotoxin works by focally blocking neuromuscular transmission, Susan Abushakra, MD — chief medical officer and co-founder of drug developer Bonti — said, showing the capability to create muscle relaxation and immobilization 24 hours into treatment.

Rather than disillusion the body from the sensation of pain, it works to alleviate it.

“In muscle spasms, it treats not just pain, but the underlying cause of pain,” Abushakra said.

Though the treatment’s designation in the market is currently closer to aesthetic use — as indicated in the Phase II frown line study — Bonti projects its utility in hospital, ambulatory, emergency, and general clinician settings for pain therapy.

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