Allergan Aesthetics, announced positive topline results from the second of three Phase 3 clinical studies evaluating onabotulinumtoxinA (BOTOX Cosmetic) for the treatment of moderate to severe platysma prominence associated with platysma muscle activity (M21-310). Platysma prominence is an aesthetically unappealing disruption to the neck, jawline and lower face that is attributed to contraction of the platysma muscle,1 a superficial, flat muscle in the lower face and neck. The multicenter, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of a single treatment of onabotulinumtoxinA (BOTOX Cosmetic) versus placebo in 426 adult subjects with moderate to severe platysma prominence.

The primary endpoint was met, demonstrating statistical significance for improvement with onabotulinumtoxinA (BOTOX Cosmetic) versus placebo (pAbout Platysma Prominence Platysma prominence is an aesthetically unappealing disruption to the neck, jawline and lower face that is attributed to contraction of the platysma muscle, a superficial, flat muscle in the lower face and neck, which contributes to the formation of facial expressions. In addition to vertical muscular bands, the contraction of formation of horizontal lines below the mandible and chin, blunting the jawline. While a sign of aging neck, platysma prominence may become visible at a younger age in some patients. Current treatment options include surgical approaches such as lower rhytidectomy (neck lift) and platysmaplasty. BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in th appearance of - Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity- Moderate to severe lateral canthal lines associated with orbicularis oculi activit - Moderate to severe forehead lines associated with frontalis activity. Lack of Interchangeability Between Botulinum Toxin Products  The potency units of BOTOX Cosmetic are specific to the preparation and assay method utilized.

They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.  Spread of Toxin Effect: Please refer to Boxed Warning for Distant Spread of Toxin Effect. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur. Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures.

In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There isinsufficient information to identify factors associated with an increased risk for adverse reactions associated established. Serious and/or immediate hypersensitivity reactions have been reported.

These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System There have been reports following administration of BOTOX of adverse events involving the ca rdiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin.Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA.