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Preparing for Revance Therapeutics’ Phase 3 pivotal trial data releases of RT002 botulinum toxin injectable for the treatment of glabellar (frown) lines in Q4 2017Ticker(s): RVNC, AGN, NESN.VX
Name: Dr Katie Beleznay - MD
Institution: UBC and Carruthers & Humphrey Cosmetic Medicine
- Clinical Instructor with the University of British Columbia Department of Dermatology; board certified dermatologist in both Canada and the United States and is fellowship trained in laser and cosmetic dermatology.
- Treats 5-15 patients a day 4 days a week with Botox.
- Sub-investigator for the BELMONT Phase 2 trial of DaxibotulinumtoxinA Injectable (RT002).
Please describe your clinical practice, what is the most often botulinum toxin that you use, what do patients prefer best, and tell us how well could a new product fit into the market?Added By: joe_mccann
The company cites that RT002 maintains benefit for 5 months, compared to other botulinum toxin injections available on the market benefit of 3 months.
- the 40U dose of daxibotulinumtoxin A (RT002) showed a greater response rate and a longer duration of response vs 20U onabotulinumtoxinA (median of 24 weeks vs 19 weeks; p = .030)
- Judging from your clinical experience, is this true, especially considering how age, skin tan, face structure and other factors can affect the time span of the treatment?
If the Phase 3 data turns out positive, the company wants to file for a 6-month duration label with the FDA. Do you think this is achievable, or is it over-reaching?
- Would the twice per year procedure for returning patients be more convenient for you and your patients?
The long-term safety trial is expected to enroll approximately 1,500 subjects, and a subject may be on trial for a maximum of 84 weeks. Do you foresee any adverse effects that might come with the prolonged exposure to the toxin, such as ptosis, pain, rashes, infection, muscle damage or spasms, that could endanger the approval of RT002?Added By: joe_mccann
More than twice as many RT002 40U and 60U subjects in the BELMONT Study maintained none or mild wrinkles on the IGA-FWS scale as compared to BOTOX Cosmetic at Week 16 (p ≤ 0.002). Is this a strong argument in itself to make the switch from botox to RT002 tempting? And what other factors could be influencing you to make the switch?Added By: joe_mccann
What might have been the reasons behind the Phase 2 Plantar Fasciitis clinical trial suspension, and then the initiation of a new one, in the same indication?Added By: joe_mccann
How different is the dosing between RT002 and BOTOX? I know dosing differences between BOTOX and DYSPORT were played up by Allergan calling switching to DYSPORT “like learning a different language”Added By: joe_mccann
Could a company like Revance compete vs. the other toxins without a full line of products? How important are loyalty programs in this space and can the maker of RT002 do anything to compete on this plane?Added By: joe_mccann
Q9. In your opinion, how important is RT002’s formulation that combines proprietary peptide that purports to help toxin’s effect last longer ?Added By: rajuramas
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