Abstracts

Conference Abstracts – PDF Version

Treatment of Schizophrenia

  1. Gomeni, R., Heidbreder, C., Fudala, P.J., Nasser, A. (2013) A model-based approach to characterize the relationship between the long-lasting pharmacokinetic (PK) time-course and the safety profile of RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Indianapolis, March 5th-9th, 2013.
  2. Gomeni, R., Heidbreder, C., Fudala, P.J., Nasser, A. (2013) A model-based approach to characterize the long-lasting pharmacokinetic (pk) time-course of RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Indianapolis, March 5th-9th, 2013.
  3. Gomeni, R., Laffont, C.M., Zheng, B., Heidbreder, C., Fudala, P.J., Nasser, A. (2014) A dose-switching simulation analysis from INVEGA® SUSTENNA® (paliperidone palmitate) or RISPERDAL® CONSTA® to RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #14-A-53-ASCPT, Atlanta, March 18th-22nd, 2014.
  4. Min, L., Heidbreder, C., Fudala, P.J., Nasser, A. (2014) A model-based approach to characterize risperidone release, absorption, and disposition after administration of RBP-7000 in schizophrenic patients. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #14-A-115-ASCPT, Atlanta, March 18th-22nd, 2014.
  5. Jones J.P. III, Fudala, P.J., Heidbreder, C., Nasser A. (2015) Modeling and simulation to evaluate possible consequences of dose dumping for rbp-7000, a new sustained-release formulation of risperidone (Ris). Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #15-A-818-ASCPT, New Orleans, March 3rd-7th, 2015.
  6. Li, M., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A model-based approach to characterize risperidone release, absorption, and disposition after administration of RBP-7000 in schizophrenic patients. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd, 2014.
  7. Laffont C.M., Gomeni R., Zheng B., Heidbreder C., Fudala P.J., Nasser A.F. (2014) Population PK modeling and simulation to support dose selection of RBP-7000, a new sustained-release formulation of risperidone, in schizophrenic patients. Proceedings of the 23rd Meeting of the Population Approach Group in Europe (PAGE), Alicante, Spain, June 10th-13th, 2014.
  8. Laffont C.M., Ivaturi, V., Gobburu, J., Gopalakrishnan, M., Zhang, W., Jones, J.P. III, Twumasi-Ankrah, P., Heidbreder, C., Nasser, A.F. (2016) Exposure Response Analysis for a New Once a Month Long Acting Risperidone for Schizophrenia. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), San Diego, March 8th-12th, 2016.
  9. Konsoula, Z., Heidbreder, C., Twumasi-Ankrah, P., Agarwal, S., Jones, J.P. III, Nasser, A.F. (2016) Association of genetic polymorphisms and response to RBP-7000 in patients with schizophrenia. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), San Diego, March 8th-12th, 2016.
  10. Graham, J., Csernansky, J., Fava, M., Newcomer, J., Andorn, A., Shinde, S., Muma, G., Heidbreder, C. (2017) Long-Term Safety and Tolerability of a New Monthly Extended-Release Formulation of Risperidone (RBP-7000) in the Treatment of Subjects with Schizophrenia. Proceedings of the Annual Meeting of the American College of Neuropsychopharmacology (ACNP), Palm Springs, December 3rd-7th, 2017.

 

Treatment of Opioid Use Disorder

  1. Nasser, A., Heidbreder, C., Fudala, P.J., Sutton, H., Zheng, B., Greenwald, M.K. (2014) A model-based approach to evaluate the PK and mu-opioid receptor occupancy of RBP-6000, a once monthly depot formulation of buprenorphine. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #14-A-113-ASCPT, Atlanta, March 18th-22nd, 2014.
  2. Jones J.P. III, Liu, Y., Fudala, P.J., Heidbreder, C., Nasser A. (2015) The effect of hepatic impairment (HI) or HCV infection on the pharmacokinetics (PK) of buprenorphine and naloxone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #15-A-599-ASCPT, New Orleans, March 3rd-7th, 2015.
  3. Jia, H., Greenwald, M.K., Vince, B., Fudala, P.J., Heidbreder, C., Nasser A. (2015) A multiple-dose study of blockade of opioid subjective effects by subcutaneous injections of depot buprenorphine in subjects with opioid use disorder. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #15-A-554-ASCPT, New Orleans, March 3rd-7th, 2015.
  4. Laffont C.M., Gomeni R., Heidbreder C., Jones, J.P. III, Nasser A.F. (2016) Population Pharmacokinetic Modelling after Repeated Administrations of RBP-6000, a New, Subcutaneous Formulation of Buprenorphine for the Treatment of Opioid Use Disorder. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), San Diego, March 8th-12th, 2016.
  5. Learned, S., Haight, B., Laffont, C., Li, D., Fudala, P., Heidbreder, C. (2017) RBP-6000 Buprenorphine Monthly Depot Demonstrates Efficacy, Safety, and Exposure/Response Relationship in Opioid Use Disorder. Proceedings of the Annual Meeting of the College on Problems of Drug Dependence (CPDD), Montreal, June 17th-22nd, 2017.
  6. Jones, A.K., Ngaimisi, N., Gopalakrishnan, M., Young, M., Laffont, C.M. (2017) Long-term Exposure of RBP-6000 Buprenorphine Monthly Formulation for the Treatment of Opioid Use Disorder: A Combined Population Pharmacokinetic Analysis. Proceedings of the Annual Meeting of the American Conference on Pharmacometrics (ACoP), Fort Lauderdale, October 15th-18th, 2017.
  7. Ngaimisi, N., Gopalakrishnan, M., Ivaturi, V., Zhang, W., Young, M., Laffont, C.M. (2017) Exposure-Response Analyses to Support Dosing Recommendations for RBP-6000 Buprenorphine Monthly Formulation in Subjects with Opioid Use Disorder. Proceedings of the Annual Meeting of the American Conference on Pharmacometrics (ACoP), Fort Lauderdale, October 15th-18th, 2017.
  8. Haight, B., Learned, S., Laffont, C., Li, D., Fudala, P., Heidbreder C. (2017) RBP-6000 Buprenorphine Monthly Depot Demonstrates Efficacy, Safety, and Exposure/Response Relationship in Opioid Use Disorder: Results of a Phase 3 Clinical Trial. Colloque International Addictions Toxicomanies Hépatites SIDA (ATHS), Biarritz, October 17th-20th, 2017.
  9. Apelt, S., Dematteis, M., Benyamina, A.,  Farah, M.,  Mankabady, B. (2017) A Retrospective Observational Survey on Buprenorphine/Naloxone (SUBOXONE®) Use in France. Colloque International Addictions Toxicomanies Hépatites SIDA (ATHS), Biarritz, October 17th-20th, 2017.
  10. Learned, S., Haight, B., Laffont, C., Li, D., Fudala, P., Heidbreder, C. (2017) RBP-6000 Buprenorphine Monthly Depot Demonstrates Efficacy, Safety, and Exposure/Response Relationship in Adults with Opioid Use Disorder: Results of a Phase 3 Clinical Trial. Proceedings of the Annual Meeting and Scientific Conference of the Canadian Society of Addiction Medicine (CSAM), Niagara Falls, October 19th-21st, 2017.
  11. Haight, B., Andorn, A., Laffont, C., Gray, F., Young, M., Jones, A., Learned, S., Li, D., Heidbreder, C. (2017). Efficacy, Safety and Exposure-Response Analyses for RBP-6000 Once-Monthly Buprenorphine Depot in Subjects with Opioid Use Disorder. Proceeding of the 19th Annual Meeting of the International Society of Addiction Medicine (ISAM), Abu Dhabi, October 26th-29th, 2017.
  12. Nadipelli, V.R., Solem, C.T., Ronquest, N.A., Yeh, Y, -C., Heidbreder, C., Learned, S.M., Mehra, V. (2017) Impact of RBP-6000 on Patient-reported Outcomes in Patients with Opioid Use Disorder: Results of a Randomized, Placebo-controlled, Phase 3 Study. Proceedings of the Association for Medical Education and Research in Substance Abuse (AMERSA), Washington D.C., November 5th-7th, 2017.
  13. Learned, S., Haight, B., Laffont, C., Li, D., Fudala, P., Heidbreder, C. (2017) RBP-6000 Buprenorphine Monthly Depot Demonstrates Efficacy, Safety, and Exposure/Response Relationship in Opioid Use Disorder. Proceedings of the Australasian Professional Society on Alcohol and other Drugs (APSAD), Melbourne, November 12th-15th, 2017.
  14. Haight, B., Andorn, A., Laffont, C., Young, M., Jones, A., Learned, S., Li, D., Heidbreder, C. (2017) RBP-6000 Buprenorphine Monthly Depot Demonstrates Sustained Clinical Efficacy and Safety in Phase III Opioid Use Disorder Trials. Proceedings of the Annual Meeting of the American College of Neuropsychopharmacology (ACNP), Palm Springs, December 3rd-7th, 2017.
  15. Laffont, C.M., Ngaimisi, E., Gopalakrishnan, M., Young, M., Haight, B., Learned, S.M., Heidbreder, C. (2017) Predictors of Retention in Treatment for Opioid Use Disorder Following Administration of RBP-6000 vs. Placebo. Proceedings of the 28th Annual Meeting and Scientific Symposium of the American Academy of Addiction Psychiatry (AAAP), San Diego, December 7th-10th, 2017.

 

Rescue Medications

  1. Zheng, B., Liu, Y., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A model-based approach to predict plasma/brain cocaine levels following RBP-8000, a double mutant bacterial cocaine esterase, administration in humans. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #14-A-124-ASCPT, Atlanta, March 18th-22nd, 2014.
  2. Chen, Y., Zheng, B., Liu, Y., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A double-blind, placebo-controlled study to evaluate the effects of RBP-8000 on cocaine PK and cocaine-induced physiological effects in cocaine users. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), #14-A-149-ASCPT, Atlanta, March 18th-22nd, 2014.