botulinum toxin

Revance Botulinum Toxin Achieves Six-Month Duration in Phase 3 Trials

Revance releases phase 3 clinical data

Revance Therapeutics’ DaxibotulinumtoxinA for Injection (RT002) achieved six-month duration in two pivotal SAKURA Phase 3 clinical studies for the treatment of glabellar lines. RT002 met its primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines in both SAKURA 1 and SAKURA 2.

Milestone Scientific To Launch New Neurotoxin Delivery Instrument

Milestone Scientific, a developer of computerized drug delivery instruments, is planning to introduce a cosmetic injection instrument for delivery of botulinum toxins. The wireless electronic device, which uses comfort speed technology already available for dental Novocain injections, offers precise dosing with less pain upon injection. It includes a touchscreen interface and integrated electronic record-keeping capability.

Bonti Releases Phase 2A Clinical Study Data for its Botulinum Toxin Product

New E serotype E botulinum toxin completes first clinical trial

Bonti, a clinical-stage biotechnology company, has announced topline results of the first clinical study of its lead product candidate, EB-001, in glabellar lines. EB-001 is a novel serotype E botulinum neurotoxin with a unique efficacy profile, characterized by fast onset of action (about 24 hours) and short duration of effect (about 4 weeks).

Revance Therapeutics Begins RT002 Studies

Revance Therapeutics commenced a pair of double-blind, placebo-controlled, North American Phase 3 trials to evaluate single injections of drug candidate DaxibotulinumtoxinA (RT002) for the treatment of glabellar lines in about 600 total patients. The trials follow the successful BELMONT study that showed RT002 delivered six-month duration of effect, with no ptosis at the 40-unit level, in treating frown lines.

Ultrasound Guidance More Accurate Than Clinical Markings in Masseter Injections

Ultrasound Guidance More Accurate Than Clinical Markings in Masseter Injections

Individual anatomical variations can make it difficult to safely and effectively treat bruxism with neuromodulators, leading researchers Natacha Quezada-Gaon, MD, et al, of Pontifical Catholic University’s Department of Dermatology in Santiago, Chile, to investigate the use of ultrasound-guided injections. Thirty patients with bruxism were treated with botulinum toxin injections in each masseter muscle. The authors used ultrasound imaging and clinical markings—which were later compared—to guide their injections in 20 patients and clinical markings only in 10 cases.

Revance Reports Positive RT002 Results

Revance Reports Positive RT002 Results

Revance Therapeutics has announced positive 24-week results from its multicenter BELMONT Phase 2 active comparator study of injectable RT002 for the treatment of glabellar lines. RT002 is an injectable botulinum toxin type A investigational drug. The ongoing study has enrolled 268 subjects to compare the safety, efficacy and duration of effect of three doses of RT002 against placebo and current market leader, Botox Cosmetic (Allergan).

Beyond Relaxing Lines

The growing options and indications for botulinum toxin type A suggest this well-established tool will continue to dominate aesthetic medicine.
Beyond Relaxing Lines

Botulinum toxin type A (BTX-A) formulations such as Botox (Allergan), Dysport (Galderma) and Xeomin (Merz) have moved well beyond their accepted roles as temporary erasers of glabellar lines, forehead rhytides and crow’s feet. Today, they are routinely employed all over the face and neck, and are being investigated for an impressive array of new indications.

Botulinum Toxin Increases Skin Elasticity and Pliability

Botulinum Toxin Increases Skin Elasticity and Pliability

In an effort to better understand the mechanism of action of onabotulinum toxin A on skin elasticity, researchers James P. Bonaparte, MD, MSc, FRCSC, and David Ellis, MD, FRCSC, conducted a study in which 48 women (mean age 55.2 years) underwent botulinum toxin injections for mild wrinkles in the glabella and around the eyes. The patients were assessed at baseline and after injection at two weeks, two months, three months and four months to measure skin pliability, elastic recoil and the ratio of viscoelastic resistance to elastic resistance.

ALPHAEON Initiates Phase 3 EVOSYAL Study

The U.S. Food and Drug Administration (FDA) has agreed to ALPHAEON’s protocol for a Phase 3 clinical study of EVOSYAL, a botulinum toxin type A neuromodulator, for the treatment glabellar lines.

In the last 12 months, ALPHAEON, a subsidiary of Strathspey Crown Holdings, submitted its investigational new drug application for EVOSYAL as well as completed enrollment in its Phase 2 study. Enrollment of the Phase 3 trial began on January 14, 2015.