NEW YORK Two drug makers have started a late-stage clinical trial of a drug developed by Soviet Union scientists in the 1980s to evaluate it as a treatment for Huntington disease.
Pfizer and Medivation announced Thursday the start of a phase 3 trial of dimebon (latrepirdine), saying that the Food and Drug Administration had granted the drug orphan drug designation. The FDA grants the designation to investigational drugs for conditions that affect fewer than 200,000 people in the United States each year.
The drug was originally developed as an antihistamine, but has attracted the attention of researchers as a possible treatment for Huntington disease and Alzheimer’s disease.
“Based on the promising results of our phase 2 trial of dimebon in Huntington disease, we are pleased to advance dimebon into late-stage clinical development,” Medivation chief medical officer Lynn Seely said in a statement. “Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition.”