Medication Discovery Texas, Inc — Department of Health and Human Services STTR Phase II: DESCRIPTION (provided by applicant): Though not specifically FDA-approved for this indicat

Description

DESCRIPTION (provided by applicant): Though not specifically FDA-approved for this indication, topiramate is among the most effective medication treatments for alcohol dependence. Topiramate is rarely used to treat alcohol dependence, however, because it has prominent side effects including somnolence, dizziness, and cognitive disturbances that require gradual dose titration. Many patients stop taking topiramate before it helps them to reduce drinking. We have identified carisbamate as a new candidate treatment for alcohol dependence because it shares topiramate's mechanism of action but lacks topiramate's troubling side effects. Further, unlike other anticonvulsants, both carisbamate and topiramate reduce alcohol intake in rodents. Carisbamate has been tested extensively as a treatment for epilepsy and is safe and well tolerated. Medication Discovery Texas, Inc and Baylor College of Medicine (the Small Business and academic applicants) are collaborating with SK Biopharmaceuticals (the patent holder) to develop and commercialize carisbamate as a treatment for alcohol dependence. Our Phase I Specific Aim is to conduct a human laboratory study to determine the safety profile of administering a mildly intoxicating dose of alcohol during treatment with carisbamate(n=20, two groups of 10). Milestone 1 is that study participants are able to tolerate carisbamate dosing (300 mg bid) daily for four days without significant side effects and milestone 2 is that carisbamate did not excessively exacerbate the effects of amildly intoxicating dose of alcohol given as a challenge during carisbamate treatment. Our Phase II Specific Aim is to complete a double-blind, randomized placebo-controlled outpatient clinical trial (n=72, two groups of 36). The trial will evaluate the efficacy of carisbamate for reducing percent heavy drinking days among treatment-seeking alcohol-dependent patients receiving medical management. If these trials demonstrate efficacy, Medication Discovery Texas will seek outside funding to support the clinical development needed for FDA approval of carisbamate as a treatment for alcohol dependence. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Medication Discovery Texas, Inc and Baylor College of Medicine (the Small Business and academic applicants) and SK Biopharmaceuticals (the patent holder) are collaborating to develop and commercialize carisbamate as a treatment for alcohol dependence. Because there is a large market for a successful medication treatment of alcohol dependence, a successful clinical trial will likely attract significant investor interest, ensuring further commercial development of carisbamate for this indication.