Vigabatrin: Additional Phase II data

Additional data from the double-blind, U.S. Phase II CPP-01004 trial in 186 cocaine addicts showed that twice-daily 1.5 g vigabatrin for 12 weeks did not lead to visual acuity reductions or significant peripheral visual constriction vs. placebo. Data were published in the American Journal of Ophthalmology. Previous studies have shown that vigabatrin causes irreversible visual loss. Catalyst is developing the product as a bioequivalent to Sabril vigabatrin, which is marketed outside of the U.S. by Sanofi (Euronext:SAN; NYSE:SNY, Paris, France) to treat adult epilepsy and infantile spasms. Sabril's label notes that a patient's risk of vision loss may be higher with increased dosing and duration of treatment with the drug. ...