Characterization of diffusion and duration of action of a new botulinum toxin type A formulation

Botulinum toxin: State of the art

“…One new formulation of BoNT undergoing clinical trials is daxibotulinumtoxinA (RT002; Revance Therapeutics, Inc., Newark, CA), also referred to as RTT150, which is composed of purified 150 kDa BoNT/A, free of accessory proteins, formulated in a lyophilized drug product containing a novel excipient RTP004, a single, straight chain, synthetic peptide consisting of 35 L‐amino acids. When compared with onaBoNT/A (Botox) in 2 murine models, presumably as a result of the excipient RTP004, RT002 was found to reduce diffusive spread of the active ingredient to neighboring muscles and promote a greater degree and duration of response . In a preliminary 24‐week report of daxibotulinumtoxinA (RT002) in the treatment of cervical dystonia in 37 patients assessed with the TWSTRS and a number of other secondary measures, there was a reduction of a mean of 16.8 points (or 38%) in the TWSTRS total score at week 4, which was considered clinically meaningful .…”

“…When compared with onaBoNT/A (Botox) in 2 murine models, presumably as a result of the excipient RTP004, RT002 was found to reduce diffusive spread of the active ingredient to neighboring muscles and promote a greater degree and duration of response. 75 In a preliminary 24-week report of daxibotulinumtoxinA (RT002) in the treatment of cervical dystonia in 37 patients assessed with the TWSTRS and a number of other secondary measures, there was a reduction of a mean of 16.8 points (or 38%) in the TWSTRS total score at week 4, which was considered clinically meaningful. 76 The median duration of effect, as defined by time since treatment till patients losing 80% of improvement achieved at week 4 in the TWSTRS total score, was longer than 24 weeks for cohort 1 with the longest follow-up.…”

Detection of Botulinum Toxin Muscle Effect in Humans Using Magnetic Resonance Imaging: A Qualitative Case Series

“…Surprisingly few data are available on convection and diffusion in human muscle [17]. Despite the limitations in generalizing results to humans [21], animal studies demonstrate that BT moves into adjacent muscles [22][23][24][25][26][27][28][29][30][31] and that higher doses result in a wider BT muscle distribution [22,29,[31][32][33]. The effect of dilution and serotype on BT distribution in animals is somewhat less clear [23,24,28,30,[32][33][34].…”

A Novel Botulinum Neurotoxin Topical Gel: Treatment of Allergic Rhinitis in Rats and Comparative Safety Profile

“…A RT001-like formulation in development for intramuscular use has been shown to result in more targeted delivery of BoNTA to the intended treatment site in comparison with BoNTA complex formulation. 34 This safety profile of RT001 was confirmed in a comparative safety study with BoNTA complex in guinea pigs showing RT001 to be ϳ31-fold safer Copyright (c) Oceanside Publications, Inc. All rights reserved. For permission to copy go to https://www.oceansidepubl.com/permission.htm compared with BoNTA complex.…”