FDA Approves Botox for Cervical Dystonia
The Food and Drug Administration has approved Botox, a botulinum toxin type A, as a treatment for cervical dystonia, a neurological movement disorder that causes neck spasms and pain. This approval is the second this month, following the approval of a similar drug, Myobloc or botulinum toxin type B, for the same condition. According to the FDA, as many as 50,000 people who suffer from cervical dystonia can now use Botox to combat the condition.
Key Takeaways:
- The FDA has approved Botox, a botulinum toxin type A, for the treatment of cervical dystonia, a neurological movement disorder that causes neck spasms and pain.
- Approximately 50,000 people suffer from cervical dystonia, a condition that can cause significant physical and emotional pain.
- Botox was previously approved for the treatment of other disorders caused by abnormally tensed or rigid muscles.
- The FDA has mandated that Allergan, the manufacturer of Botox, conduct a 250-patient, two-year post-marketing study to evaluate the safety of the drug in cervical dystonia.
- Allergan has already performed long-term studies involving 170 patients to prove the effectiveness of Botox for the treatment of cervical dystonia.
- The American Academy of Neurology has endorsed the use of Botox for cervical dystonia for over a decade.
Statistics:
- 50,000: The estimated number of people who suffer from cervical dystonia.
- 20 years: The amount of time that purified forms of botulinum toxin have been used in medical treatments.
- 250 patients: The number of participants in the post-marketing study to evaluate the safety of Botox in cervical dystonia.
- 2 years: The duration of the post-marketing study to assess the safety of Botox in cervical dystonia.
- 10 years: The amount of time that the American Academy of Neurology has endorsed the use of Botox for cervical dystonia.
Sources:
- UPI (Washington, DC), December 27 (2000)
- United Press International, December 12 (2000)
- Dystonia Medical Research Foundation (Chicago, IL)