First Drug for Treatment of Chorea in Huntington’s Disease.
The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.
Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington’s disease. Currently there are no other drugs that are FDA-approved to treat chorea.
Serious side effects reported with use of Xenazine include depression and suicidal thoughts and actions. Xenazine should not be used in patients who are actively suicidal or in patients with untreated depression. Concerns about the risk of suicide are heightened in all patients with Huntington’s disease.
Anti-Epileptic Drugs and the Risk of Suicide.
[...]The United States Food and Drug Administration (FDA) has evaluated the risk of suicide associated with antiepileptic drugs. The FDA examined 11 antiepileptic drugs, among nearly 28,000 patients, and found that patients taking an antiepileptic drug have an increased risk for suicidal behavior or ideation, compared to 16,000 patients receiving a placebo.
The FDA’s assessment consisted of reviewing 199 placebo-controlled trials evaluating the safety and efficacy of various antiepileptic drugs (also known as anticonvulsants). The following drugs were included in the review: carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakene, Depacon), and zonisamide (Zonegran). Although only these drugs were included in the review, experts suggest that all anticonvulsant drugs carry the same risk. Antiepileptic drugs are not just used to treat epilepsy. They can be used to treat psychiatric disorders, including bipolar disorder, depression, and anxiety, as well as migraines and neuropathic pain[...]
“Xenazine represents hope for patients and families dealing with this difficult disease,” said Timothy Coté, M.D., M.P.H., director of FDA’s Office of Orphan Products Development. “For the first time, there is a treatment that can help patients with this disease gain some quality of life.”
Huntington’s disease is a rare, inherited neurological disorder affecting about 1 in 10,000 people in the United States. The disease results from genetically programmed degeneration of brain cells. The deterioration causes uncontrolled movements, loss of intellectual faculties, and emotional disturbance. Huntington’s disease is passed from parent to child through a gene mutation. Each child of a parent with the disease has a 50 percent chance of inheriting the mutation.
About 30,000 people in the United States have Huntington’s disease and another 200,000 are at risk of developing the condition. Symptoms commonly develop between ages 30 and 50. The disease progresses slowly and a person may live for another 15-20 years after the onset of symptoms.
Xenazine decreases the amount of dopamine available to work at relevant synapses in the brain. Dopamine is a chemical that communicates between certain nerve cells in the brain. In patients with Huntington’s disease, this system is overactive and results in the abnormal movements called chorea. Xenazine decreases the amount of dopamine available to interact with certain nerve cells, thereby decreasing the involuntary movements.
Women Are Four Times as Likely as Men to Suffer From Depression - New FDA Approved Therapy.
[...]Developing new coping strategies — such as enlisting the support of your family, and trying to limit over scheduling yourself on the days when your symptoms are likely to be at their worst — can be extremely helpful. Some popular treatments like vitamin B-6, evening primrose oil and thyroid hormone have generally not been found to be helpful.
However, many strategies and antidepressants don’t work in the long term. The FDA has approved the only long term treatment option for depression; vagus nerve stimulation. Vagus nerve stimulation therapy involves a ninety-minute out-patient procedure. IT is NOT related to shock treatments or ECT. Vagus nerve stimulation changed my life completely from one of utter despair to genuine happiness and joy. There is no article long enough to express my gratitude for this remarkable therapy[...]
The effectiveness and safety of Xenazine was established primarily in a randomized, double-blind, placebo-controlled multi-center clinical trial. Patients treated with Xenazine had a significant improvement in chorea compared to patients treated with placebo. Other studies provided additional support for this effect.
The most common side effects reported by patients using Xenazine in clinical trials include insomnia, depression, drowsiness, restlessness and nausea.
While the drug has been shown to decrease chorea in the short-term, it also showed slight worsening in mood, cognition, rigidity, and functional capacity in clinical trials. Health care professionals and family members of patients taking the drug should pay attention to all of the facets of the disease.
Xenazine has been approved with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions. REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product.
Vagus Nerve Stimulation is FDA Approved for Depression and being prescribed by MD’s
[...]Vagus nerve stimulation(VNS) is a safe, FDA approved treatment for chronic or recurrent depression. VNS has increasingly been more accepted by the psychiatric community as its robust antidepressants effects of this treatment has on key areas of the brain is better understood by psychiatrists.
During 2006, the manufacturer of the stimulator plans to continue to educate psychiatrists and general practioners about this ninety minute out-patient procedure. Here a few of the plans:
1. Three-hundred thirty representatives and case managers are participating in this nationwide education process. In addition to the face-to-face meetings with psychiatrists, the awareness and education process will include:
2. Satellite Broadcast Event in 50 cities for 1,750 psychiatrists
3. Fifty nationwide symposiums for 3,200 psychiatrists[...]
The REMS includes educational materials for prescribers, pharmacists and patients (and their caregivers) to help minimize adverse effects associated with Xenazine. It also includes a Medication Guide, which informs patients and their caregivers about the risks of depression, suicidal thoughts and actions, and other side effects. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.
Xenazine was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. A drug is also eligible for orphan drug designation if it is intended to treat a disease or condition that affects more than 200,000 people in the United States, but there is no reasonable expectation that the cost of developing and making available a drug for the disease or condition will be recovered from sales of the drug.
Nov 8th, 2008 at 8:45 pm
Thanks for the information on Huntington’s disease. It’s great to know that there is a new drug out there for it!
We recently wrote an article on Huntington’s Disease at Brain Blogger. Out of all the people who have Huntington’s Disease, less than 10% are under 20. It may not seem like that much more of an important factor, but it makes the struggle so much harder.
We would like to read your comments on our article. Thank you.
Sincerely,
Kelly