HD Lighthouse Contributing Editor's Comment:
--
Posted to the HDL: 29 Jan 2006

Marsha L. Miller, Ph.D.

Many of you have been inquiring about the status of FDA approval for the anti-chorea drug tetrabenazine. Tetrabenazine is produced by Prestwick Pharmaceuticals, a company whose mission is to "discover, develop, and make available new treatments that meet unmet medical needs for people suffering from central nervous system (CNS) diseases."

Prestwick executives Kathleen Clarence-Smith, M.D., Ph.D., CEO, and Ben Lewis, Ph.D., Vice-President of Regulatory Affairs answered questions in a phone interview on January 27, 2006.

I learned that the application is on track. Prestwick submitted their official drug application at the end of September. Tetrabenazine has received fast track status so the review time will be six months. They expect to hear something by the end of March or early April.

Tetrabenazine was approved in the United Kingdom in the early 70s. When approved by the FDA, it will be a new drug in the United States although some patients have been able to get the drug through Canadian pharmacies.

Dr. Clarence-Smith spoke of the need to titrate up to the individual patient’s correct dose to avoid the potential side effects of depression, Parkinsonism, and sedation. She reported that the drug works for about 80 percent of patients.

I relayed concerns about depression since we've heard on the Forum about some new users who experienced this side effect. According to Dr. Clarence-Smith, about 60 percent of patients who take tetrabenazine are already on antidepressants. If depression occurs, it can be dealt with by adding an antidepressant, increasing the dosage of an antidepressant the patient is already taking, or reducing the dosage of tetrabenazine.

I also asked about recent price increases in Canada and was told that Prestwick was losing money at the old price in Canada so prices were raised.

It was a pleasure to talk to two people who have a real concern for the quality of life of people with Huntington's Disease.

Research updates about tetrabenazine were presented on each of the following two pages:
VMAT2, a Drug Target Implicated in Multiple CNS Disorders, is Focus of Scientific Symposium
New Data Reported on Tetrabenazine in Patients with Movement Disorders and a History of Depression

Tracked on the Lighthouse:
tetrabenazine
Prestwick

# # #

Source:

printer friendly version

 

	Read the HDAC/HDLighthouse Forum. Post your comments