22 November 2017 - - The US Food and Drug Administration has granted orphan drug designation for Newark, California-based botulinum toxin products developer Revance Therapeutics, Inc.'s (NASDAQ: RVNC) product candidate, DaxibotulinumtoxinA for Injection (RT002), to treat cervical dystonia, a movement disorder of the neck, in adults, the company said.
According to the Dystonia Medical Research Foundation, 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.
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.
DaxibotulinumtoxinA for Injection has the potential to be the first long-acting neuromodulator. It is also currently in development for the treatment of glabellar lines and plantar fasciitis.
Revance is developing a portfolio of products for aesthetic medicine and underserved therapeutic specialties, including dermatology, orthopedics, and neurology. Its science is based upon a proprietary peptide technology, which when combined with active drug molecules, may help address current unmet needs.
The company's initial focus is on developing daxibotulinumtoxinA, the company's highly purified botulinum toxin, for a broad spectrum of aesthetic and therapeutic indications.