OREX-004
OREX-004 is the working name we have given to the naltrexone SR/fluoxetine combination product candidate that we are currently developing for the treatment of obsessive-compulsive disorder, or OCD. We hold the exclusive license to two issued U.S. patents covering the Contrave composition and expect that they will similarly cover OREX-004, and we own or have exclusive rights to two patent applications currently pending in the United States and a number of corresponding patent applications currently pending in various foreign countries with respect to various compositions, methods of use and formulations relating to this product candidate.
We believe that the addition of naltrexone to an SSRI may improve outcomes for some sufferers of OCD. The compulsive features of the disease have been theorized to have a reward-based component, which is likely influenced by a balance of endogenous dopamine and opioids. The addition of an opioid antagonist such as naltrexone may dampen dopamine-based reward and thereby decrease compulsive behaviors. Naltrexone, in particular, has been reported to be useful with repetitive and impulsive behaviors including alcoholism, self-injurious behavior, kleptomania, trichotillomania (hair pulling) and compulsive gambling.
We have conducted a preclinical study examining the effect of the combination of naltrexone and fluoxetine, a commonly prescribed SSRI marketed under the brand name Prozac, in an established animal model of OCD. In this study, we showed a statistically significant reduction of compulsive behavior compared to either naltrexone or fluoxetine alone after seven days of treatment. In addition, the combination demonstrated a robust synergy in behavior improvement relative to either naltrexone or fluoxetine alone. We believe that this preclinical model may have validity in terms of predicting efficacy in humans.