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Catalyst Pharma (CPRX) Says Short-Term Use of Vigabatrin Did Not Cause Visual Acuity in Cocaine Abusers

June 28, 2012 8:07 AM EDT Send to a Friend
Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced that an ePublication on CPP-109 (vigabatrin) describing ocular safety results obtained with CPP-109 (vigabatrin) was published in the June 14, 2012 web edition of the American Journal of Ophthalmology (AJO). These results were obtained from the Company's previously completed Phase II(a), randomized, double-blind, placebo-controlled trial in cocaine addicted subjects.The paper is entitled, "Visual Field and Ocular Safety during Short-Term Vigabatrin Treatment in Cocaine Abusers" by Tamara L. Berezina, Albert S. Khouri, M. Douglas Winship and Robert D. Fechtner.

About The Article

Vigabatrin, a GABA aminotransferase (GABA-AT) inactivator, is used to treat infantile spasms and refractory complex partial seizures, and is in clinical trials by Catalyst to treat cocaine addiction. In the trial, cocaine addicts were randomized to receive either vigabatrin 1.5g/bid, cumulative dose 218g (n=92), or placebo (n=94) for 12 weeks. Subjects underwent examination of visual acuity (ETDRS) and peripheral visual field (PVF) by Humphrey Field Analyzer (HFA 60-4 program) before and after treatment. Main outcome measures included visual acuity decrease by 15 letters and/or significant PVF alteration, defined as five or more visual field location points having greater than or equal to 15dB reduction or decline (≥33% loss) in post-treatment PVF for one or more rings, both of which constitute the minimum change needed to be considered clinically significant as defined by the American Medical Association.

Results

Visual acuity decrease was detected in one eye of a subject receiving placebo and in none receiving vigabatrin. Post-treatment reduction of more than 15dB in five or more adjacent visual field location points combined with reduction of greater than 33% in one or more of the rings was detected in 2 of 54 subjects (3.7%) from the vigabatrin group versus 1 of 49 subjects (2%) from the placebo group (P=.9, NS). None of the PVF changes were bilateral or concentric, a hallmark of the changes previously reported to result from the long-term, chronic use of vigabatrin.

Conclusion

Short-term use of vigabatrin did not cause a decrease in visual acuity or significant peripheral visual field changes in cocaine abusers. These results confirm and expand upon previously published ocular safety results obtained in a study conducted by Dr. Fechtner and colleagues (Fechtner et al., Arch Ophthalmol 2006; 124:1257-62).




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