FDA Accepts Investigational New Drug Application for Cervical Dystonia Treatment

by Lauren Taylor from In The Cloud Copy

Cervical dystonia, sometimes called spasmodic torticollis, is a condition in which the affected individual’s neck muscles involuntarily contract which causes the head to twist and turn to one side. The condition can also cause the person’s head to tilt backwards and forwards uncontrollably. This is an incredibly painful condition which currently has no known cure. While treatment can sometimes resolve symptoms, a remission that is sustained is uncommon in this condition. Cervical dystonia currently affects about 50,000 people in the United States and severely limits their quality of life due to pain and mobility issues.

The cause of this painful condition remains unknown. Some patients have a family history of the disorder and some researchers believe a gene mutation is associated with the condition. In some other cases, previous head, shoulder, or neck injuries seem to play a role. Additional risk factors may include age, gender, and family history. Cervical dystonia is more commonly seen in women than men and typically occurs after the age of 30, though it can develop at any age.

There is currently no cure for the disease. Botulinum toxin, which is a paralyzing agent, is sometimes used. This is injected directly into the neck muscles and must be repeated every three to four months. Other current treatments include therapies such as sensory tricks, heat packs and massage to help improve neck strength and flexibility. In some cases where minimally invasive treatments are not helping, surgery may be recommended. The typical procedures include deep brain stimulation or cutting of the nerves that are responsible for carrying the contraction signals to the affected muscles.

AEON Biopharma To Test New Treatment

AEON Biopharma recently received news that the Food and Drug Administration (FDA) accepted their Investigational New Drug (IND) application for the drug botulinum toxin complex ABP-450. What this means is that they may now start human testing with the drug in patients with cervical dystonia in a phase 2 clinical trial. There hope is that this drug will help to improve patients afflicted by cervical dystonia.

ABP-450 is an injection that contains botulinum toxin type A that is produced by the bacterium Clostridium botulinum. When this is injected into the affected individual at therapeutic doses, a chemical denervation occurs. This causes a local reaction of reduction of activity in those muscles. It accomplishes this by blocking the release of peripheral acetylcholine at the nerve terminals.

ABP-450 is already approved in the United States, Canada, and the European Union for aesthetic reasons, but are still in the process of approval for other indications such as cervical dystonia.

Learn more about this story here.

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