Revance Plans Phase 3 Program for RT002 Injectable to Treat Cervical Dystonia

08:04 11/29/2017

Revance Therapeutics, Inc. RVNC  has completed its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, along with the receipt of Scientific Advice from the European Medicines Agency regarding DaxibotulinumtoxinA for Injection (RT002). The injection will assist in treating cervical dystonia, which is a movement disorder of the neck. By clearing these early hurdles, Revance will now proceed to a Phase 3 program in cervical dystonia. The Phase 3 program will be completed at multiple sites in the U.S., Canada and Europe, the goal of which is meet all regulatory requirements in the U.S. and Europe.

“Our discussions with the FDA and EMA were very fruitful, directing specific courses of action for our clinical program for RT002 in cervical dystonia,” said Dan Browne, President and Chief Executive Officer of Revance. “We are energized by the momentum behind our first potential therapeutic indication and are excited by the prospect of bringing this promising, long-acting therapy to those suffering from this highly debilitating disease.” Trial protocols are being finalized and the program will kick off in the second quarter of 2018.

The company reported that in May 2017 in a Phase 2 trial, RT002 appeared to be safe, well-tolerated and provided significant relief of signs and symptoms of cervical dystonia. The beneficial effects lasted at least 24 weeks. Earlier this month, the company announced that the FDA granted Orphan Drug Designation for RT002 to treat cervical dystonia. Past treatments for the condition included oral medications, botulinum injections, surgery and associated therapies. Botulism treatments block the communication between the nerve and the muscle and helps to alleviate abnormal movements and postures. The condition impacts a few hundred thousand adults in the U.S. alone, and Revance estimates the global market for treating muscle movement disorders with botulinum toxins to be $1 billion in 2015.0

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