Revance plans for RT002 injectable to treat cervical dystoniato go into Phase 3
Revance Therapeutics announced the completion of its end-of-phase 2 meeting with the FDA along with receipt of scientific advice from the Europe Medicines Agency regarding DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a movement disorder of the neck, in adults. Based on the Phase 2 safety and efficacy results, along with guidance from the FDA and EMA, Revance plans to proceed to a Phase 3 program in cervical dystonia. Revance's Phase 3 program will be conducted at multiple sites in the U.S., Canada and Europe, and will be designed to fulfill regulatory submission requirements in both the U.S. and Europe. Revance is finalizing the trial protocols for the pivotal program, which is planned to commence in 2Q18. In May, the company reported that in a Phase 2 trial, RT002 appeared to be generally safe and well-tolerated, delivered clinically significant improvement in signs and symptoms of cervical dystonia in patients, and demonstrated duration of effect of at least 24 weeks. Earlier this month, the company announced that the FDA granted orphan drug designation for RT002 to treat cervical dystonia.