botulinum toxin

FDA Sets PDUFA Date for Revance DAXI Neuromodulator

Revance Therapeutics

The United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Revance Therapeutics’ DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines. In a press release issued by Revance, the company noted that, in its correspondence, the FDA stated that no potential filing review issues were identified and indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

Botulinum Toxin Improves Facial Surgical Scars

Using Botox for Surgical Scars

A split-scar study from China revealed that botulinum toxin injections produce narrower, flatter surgical scars when compared to placebo. Between June 2015 and October 2015, Li Hu, PhD, MD, et al, randomly injected botulinum toxin type A into one side of a postoperative scar of 16 consecutive patients undergoing facial surgery. The other side of the scar was injected with 0.9 percent saline.

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.