Abstract: Provided herein is a method for weaning a subject suffering from a drug addiction or addictive behaviors involving opioid signaling by sequentially blocking peripheral and CNS opioid receptors and modulating opioid dependence.

Abstract: Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Abstract: The present invention provides methods and materials useful for determining metabolizer status. Embodiments of the present invention provide an approach using a genotyping panel and integration of genotypes of CYP3A4 and CYP3A5 to assess CYP3A metabolizer status, applicable to all CYP3A substrates, including approximately 40% of all drugs. Algorithms for CYP3A metabolizer status are described. Where the contribution ratios of CYP3A4 and CYP3A5 to overall drug levels or drug effects are known, the algorithm can be used to calculate optimal dosing. Where the contributory ratios to overall drug effects are not available, the contributory ratios can be calculated with use of the genotypes for use in drug development. Embodiments of the present invention can be used in optimizing drug treatments, selecting dose, designing therapeutics, and predicting efficacy.

Abstract: Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Abstract: The present invention provides methods and materials useful for determining metabolizer status. Embodiments of the present invention provide an approach using a genotyping panel and integration of genotypes of CYP3A4 and CYP3A5 to assess CYP3A metabolizer status, applicable to all CYP3A substrates, including approximately 40% of all drugs. Algorithms for CYP3A metabolizer status are described. Where the contribution ratios of CYP3A4 and CYP3A5 to overall drug levels or drug effects are known, the algorithm can be used to calculate optimal dosing. Where the contributory ratios to overall drug effects are not available, the contributory ratios can be calculated with use of the genotypes for use in drug development. Embodiments of the present invention can be used in optimizing drug treatments, selecting dose, designing therapeutics, and predicting efficacy.

Abstract: Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Abstract: The present invention provides methods and materials useful for determining metabolizer status. Embodiments of the present invention provide an approach using a genotyping panel and integration of genotypes of CYP3A4 and CYP3A5 to assess CYP3A metabolizer status, applicable to all CYP3A substrates, including approximately 40% of all drugs. Algorithms for CYP3A metabolizer status are described. Where the contribution ratios of CYP3A4 and CYP3A5 to overall drug levels or drug effects are known, the algorithm can be used to calculate optimal dosing. Where the contributory ratios to overall drug effects are not available, the contributory ratios can be calculated with use of the genotypes for use in drug development. Embodiments of the present invention can be used in optimizing drug treatments, selecting dose, designing therapeutics, and predicting efficacy.

Abstract: A method for predicting a subject's risk factors for CYP3A4-related disorders includes detecting the allelic status of a SNP in a nucleic acid sample of the subject.

Abstract: Methods and compositions for the effect of Cholesteryl ester transfer protein (CETP) polymorphisms on mRNA splicing, statin treatment outcome, response to CETP inhibitor drugs, and myocardial infarction risk are described.

Abstract: In some embodiments, the invention provides a non-addictive analgesic co-formulation comprising an opioid agonist in an amount sufficient to confer analgesia in a mammalian subject (such as a human) and a neutral opioid antagonist in an amount sufficient to inhibit peripheral effects of the opioid agonist, and insufficient to block substantial central effects of the opioid agonist in the subject. The formulation may be formulated for oral administration to the subject. Such formulations, and methods of using the same, may also deter diversion, inhibit peripheral effects of the opioid agonist, and reduce addiction liability.

Abstract: A method for predicting a subject's risk factors for ACE-related disorders includes detecting the allelic status of one or more polymorphisms in a nucleic acid sample of the subject.

Abstract: In some embodiments, the invention provides a non-addictive analgesic co-formulation comprising an opioid agonist in an amount sufficient to confer analgesia in a mammalian subject (such as a human) and a neutral opioid antagonist in an amount sufficient to inhibit peripheral effects of the opioid agonist, and insufficient to block substantial central effects of the opioid agonist in the subject. The formulation may be formulated for oral administration to the subject. Such formulations, and methods of using the same, may also deter diversion, inhibit peripheral effects of the opioid agonist, and reduce addiction liability.

Abstract: A non-addictive analgesic co-formulation comprising an opioid agonist in an amount sufficient to confer analgesia in a mammalian subject and a neutral opioid antagonist in an amount sufficient to inhibit peripheral effects, and insufficient to block substantial central effects, of the opioid agonist in the subject. Such formulations, and methods of using same, may also deter diversion, inhibit peripheral effects, and reduce addiction liability.

Abstract: The present invention provides methods of identifying an increased risk of a dopamine dysregulation disorder in a human subject, including identifying increased risk of dementia, Parkinson's disease, Huntington's, epilepsy, mania, attention deficit disorder, anxiety, dyslexia, schizophrenia, depression, obsessive-compulsive disorders, alcoholism, obesity, addiction disorders, pathological gambling, attention deficit hyperactivity disorder, bipolar disorder, Tourette syndrome, substance dependence, sub stance abuse, substance overdose, and substance-related death.

Abstract: In some embodiments, the invention provides a non-addictive analgesic co-formulation comprising an opioid agonist in an amount sufficient to confer analgesia in a mammalian subject (such as a human) and a neutral opioid antagonist in an amount sufficient to inhibit peripheral effects of the opioid agonist, and insufficient to block substantial central effects of the opioid agonist in the subject. The formulation may be formulated for oral administration to the subject. Such formulations, and methods of using the same, may also deter diversion, inhibit peripheral effects of the opioid agonist, and reduce addiction liability.

Abstract: Methods and compositions for the effect of Cholesteryl ester transfer protein (CETP) polymorphisms on mRNA splicing, statin treatment outcome, response to CETP inhibitor drugs, and myocardial infarction risk are described.

Abstract: A method for predicting a subject's risk factors for CYP3A4-related disorders includes detecting the allelic status of a SNP in a nucleic acid sample of the subject.

Abstract: Methods of utilizing an opioid agonist in a mammalian subject in a manner that inhibits peripheral effects of the opioid agonist are described. The methods comprise administering the opioid agonist in an amount sufficient to confer analgesia the subject and co-administering a neutral opioid antagonist or pharmaceutically acceptable isomorph or pharmaceutically acceptable salt thereof in an amount sufficient to substantially inhibit peripheral effects and insufficient to block substantial central effects of the opioid agonist in the subject.

Abstract: Methods for screening of opioid receptor neutral antagonists and inverse agonists and uses thereof are disclosed.

Abstract: A method for predicting a subject's risk factors for ACE-related disorders includes detecting the allelic status of one or more polymorphisms in a nucleic acid sample of the subject.