Cervical Dystonia Gets FDA Approved Orphan Drug RT002

Cervical Dystonia Gets FDA Approved Orphan Drug RT002

Revance Therapeutics, Inc is a leading biotechnology company that develops botulinum toxin products used for the treatment of therapeutic conditions. It recently announced that its drug candidate Daxibotulinumtoxin A for injection (RT002) had been granted the orphan drug designation to treat cervical dystonia.

Orphan drug designation provides financial and developmental benefits to companies that research on a product for the treatment of a rare condition/disease. The benefits also include clinical trial costs, tax credits and more.

Causes of cervical dystoniaWhat is cervical dystonia?

Cervical dystonia is a painful neck muscle contraction which causes abnormal postures and movement of the neck and head. Also known as spasmodic torticollis, cervical dystonia may cause the following symptoms:

  • Sustained or jerky neck movements, or a combination of both
  • Involuntary movement of head towards the shoulder which eventually leads to an unbearable headache
  • Spasms that may resemble tremors
  • Resulting neck pain radiating into the shoulders
  • The condition can occur at any age but is the most commonly found in individuals of middle age.

This condition may have primary (neurological) or secondary causes (physical trauma). According to the Mayo Clinic, this condition can spread to different areas of the body including arms, trunk, jaw, and face. If not treated effectively, it may lead to the development of bone spurs which causes weakness and numbness in limbs. Neck spasms that become intolerable may also lead to internal bleeding which is why it must be addressed immediately as it increases in intensity.

Treatment of cervical dystonia

A painful condition, cervical dystonia is currently treated with the following options:

  • Oral medications
  • Surgery
  • Botulinum toxin injections
  • Some complementary therapies

Among these, the use of botulinum toxin minimizes the communication between the muscle and nerves which suppresses the abnormal postures and movements. Some people have reported success with trying sensory tricks such as touching the opposite side of the face to stop the spasms temporarily but this may lose effectiveness as the condition progresses.

While treatments may help abate symptoms, there is no cure for cervical dystonia. In some instances, the disorder may resolve on its own without treatment, but sustained remissions are not common.

Prognosis for RT002

According to Revance, the global market investment for botulinum toxins for the treatment of muscle disorders was $1 billion by 2015.

Dan Browne, CEO and President at Revance stated that RT002 “appeared to be generally safe and well-tolerated and showed a clinically significant reduction and long-lasting improvement of subjects.”

He also said that he is pleased with the endowment of approval by FDA. The company plans on proceeding with the next steps of their cervical dystonia programs in early 2018.

Currently, treatment of cervical dystonia with botulinum toxins may take up to three months. But with RT002 the same will have the first long-acting neuromodulator treatment available.

It is hoped that the developmental efforts of this drug put by Revance therapeutics will prove effective as a solution for the treatment of cervical dystonia.

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