Revance Announces Results of Phase 2 Trial of DaxibotulinumtoxinA for Injection in Plantar Fasciitis
- Patients reported significant pain reduction that was numerically greater than placebo, however, the primary efficacy endpoint was not met –
This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA for Injection in reducing the signs and symptoms of plantar fasciitis. The trial enrolled 155 adult patients with unilateral plantar fasciitis, 18 to 65 years of age, at 17 study centers in
In the trial, both doses of DaxibotulinumtoxinA for Injection resulted in significant, measurable pain relief after treatment that was numerically greater than placebo. However, neither dose met the primary efficacy endpoint of statistically significant improvement from baseline in the NPRS for foot pain at Week 8, compared to placebo. Subjects treated with DaxibotulinumtoxinA for Injection showed an average reduction from baseline of 3.29 on the NPRS (a 54.6% reduction) at 80U (p=0.2135 vs. placebo) and 3.25 on the NPRS (a 50.1% reduction) at 120U (p=0.2205 vs. placebo, p=0.9207 vs. 80U), compared to placebo subjects at 2.75 on the NPRS (a 45.1% reduction).
DaxibotulinumtoxinA for Injection was found to be safe and well-tolerated at both doses through Week 24. There were no serious treatment-related adverse events and no dose dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity. The two most common treatment-related adverse events were (for 80 Units, 120 Units and placebo, respectively) injection site pain (6.1%, 5.6%, 5.8%) and injection site erythema (2.0%, 1.9%, 1.9%).
“While we are disappointed with these Phase 2 results, it’s important to note that no other neuromodulator has been approved for the treatment of plantar fasciitis, which is a new therapeutic category with an underlying physiology that is different from currently approved indications for muscle movement and pain disorders that utilize neuromodulators,” said
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Any statements in this press release that are not statements of historical fact, including statements about our analysis of the plantar fasciitis data; the therapeutic and commercial potential of DaxibotulinumtoxinA for Injection; the potential value of DaxibotulinumtoxinA for Injection in established neuromodulator indications, including muscle movement disorders; the process and timing of, and ability to complete, of current and anticipated future clinical development of our investigational drug product candidates; our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and the expected Prescription Drug User Fee Act (PDUFA) action date of
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: the results, timing, costs, and completion of our research and development activities; the uncertain clinical development process, including the risk that the top-line results from the
1. Med Clin N America. 2014;98(2): 339-352.
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344