Revance Therapeutics has completed its End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) and has received scientific advice from the Europe Medicines Agency (EMA) regarding DaxibotulinumtoxinA for Injection (RT002) for the treatment of cervical dystonia.
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 the second quarter of 2018.
In May 2017, 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.
“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.”
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, whose mission is to advance research, promote awareness and education, and support the needs of affected individuals, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination.
Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be brought about by secondary causes (such as physical trauma). It can result in considerable pain and discomfort.
Treatments for cervical dystonia include oral medications, botulinum toxin injections, surgery, and complementary therapies. Botulinum toxin can help block the communication between the nerve and the muscle and may alleviate abnormal movements and postures. Current botulinum toxin treatments for cervical dystonia have a duration of effect of approximately three months.
Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in the United States alone. Revance estimates the global market for treating muscle movement disorders with botulinum toxins, including cervical dystonia, was nearly $1 billion in 2015.