Medication Monitor

Generic Name (Trade Name—Company)
February 6, 2019


New product approved for 'frown lines'

Evolus announced FDA approval of prabotulinumtoxinA-xvfs, an acetylcholine release inhibitor and a neuromuscular blocking agent that temporarily improves the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) associated with corrugator and/or procerus muscle activity in adults.

Approval was supported by clinical data from two Phase III randomized, multicenter, double-blind, placebo-controlled clinical trials. Both trials met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at day 30.

Dosage is 0.1 mL (four units) by I.M. injection into each of five sites, for a total dose of 20 units.

The product may cause rare but serious adverse effects that can be life-threatening, including problems swallowing, speaking, or breathing due to weakening of associated muscles and spread of toxin effects.

The most common adverse effects include headache, eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

The product is expected to be available in spring 2019.