NEWARK, Calif., Dec. 23, 2015 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (NASDAQ:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced interim efficacy and safety results from its Phase 2 trial of its RT001 topical botulinum toxin type A investigational drug product candidate for the treatment of axillary hyperhidrosis (excessive underarm sweating). The trial was designed to evaluate safety and efficacy of two doses of RT001 applied on a single day of treatment. Although the trial sample size was not chosen to meet statistical significance, using quantitative gravimetric measurements, the data was positive and showed that a single treatment of RT001 topical gel achieved clinically meaningful efficacy at Week 4. Using the qualitative Hyperhidrosis Disease Severity Scale (HDSS), RT001 showed a strong efficacy trend for both 1-point and 2-point improvement. Both doses of RT001 appear to be safe and well tolerated.
“We are very pleased with the Phase 2 interim results, which provide strong clinical evidence establishing RT001’s ability to safely deliver botulinum toxin topically to reduce the severity and quantity of underarm sweat production,” said Dan Browne, President and Chief Executive Officer at Revance. “Quantitatively, the gravimetric data shows clinically meaningful sweat reduction for both doses of RT001 and, at the higher dose, RT001 was statistically significant versus placebo. While the qualitative self-assessment by HDSS showed a notable placebo effect between Week 2 and Week 4, we believe that, overall, the RT001 data in this study are highly meaningful from a clinical standpoint.”
Mr. Browne added, “We plan to advance RT001 into a larger, well-powered hyperhidrosis Phase 2 study in 2016, which will be designed to confirm a final dose. Upon successful completion, we will then meet with the FDA to take RT001 into Phase 3 studies.”
Read more: http://globenewswire.com/news-release/2015/12/23/798059/0/en/Revance-Announces-Positive-Phase-2-Results-for-RT001-Botulinum-Toxin-Type-A-Topical-Gel-to-Treat-Axillary-Hyperhidrosis.html