Selected Publications

One of the most valuable ways to track the progress of drugs and the industry is to read clinical trial reports in peer-reviewed journals. For your convenience, below are selected citations related to Alkermes’ products and product pipeline.

Addiction | Alcohol Dependence

Lapham S, Forman R, Alexander M, Illeperuma A, Bohn MJ. 2009. The effects of extended-release naltrexone on holiday drinking in alcohol dependence patients. Journal of Substance Abuse Treatment 36(11): 1-6.

Ciraulo DA, Silverman BL, Gastfriend DR, Pettinati HM. 2008. Early treatment response in alcohol dependence with extended-release naltrexone. Journal of Clinical Psychiatry 69(2): 190-195.

O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. 2007. Efficacy of extended-release naltrexone in alcohol dependent patients who are abstinent before treatment. Journal of Clinical Pharmacology 27(5): 507-512.

Garbutt JC, Kranzler H, O'Malley S, Gastfriend DR. 2005. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. Journal of the American Medical Association 293(13): 1617-1625.

Mental Health | Schizophrenia and Bipolar Disorder

Emsley R, Oosthuizen P, Koen L, Niehaus DJ, Medori R, Rabinowitz J. 2008. Remission in patients with first-episode schizophrenia receiving assured antipsychotic medication: A study with risperidone long-acting injection. International Clinical Psychopharmacolgy 23(6): 325-331.

Curtis VA, Katsafouros K, Möller HJ, Medori R, Sacchetti E. 2008. Long-acting risperidone improves negative symptoms in stable psychotic patients. Journal of Psychopharmacology 22(3): 254-261.

Emsley R, Medori R, Koen L, Oosthuizen PP, Niehaus DJ, Rabinowitz J. 2008. Long-acting injectable risperidone in the treatment of subjects with recent-onset psychosis: a preliminary study. Journal of Clinical Psychopharmacology 28(2): 210-213.

Vieta E, Nieto E, Autet A, Rosa AR, Goikolea JM, Cruz N, Bonet P. 2008. A long-term prospective study on the outcome of bipolar patients treated with long-acting injectable risperidone. World Journal of Biological Psychology 23: 1-6.

Marinis TD, Saleem PT, Glue P, Arnoldussen WJ, Teijeiro R, Lex A, Latif MA, Medori R. 2007. Switching to long-acting injectable risperidone is beneficial with regard to clinical outcomes, regardless of previous conventional medication in patients with schizophrenia. Pharmacopsychiatry 40(6): 257-263.

Simpson GM, Mahmoud RA, Lasser RA, Kujawa M, Bossie CA, Turkoz I, Rodriguez S, Gharabawi GM. 2006. A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder. Journal of Clinical Psychiatry 67(8): 1194-1203.
 
Gastpar M, Masiak M, Latif MA, Frazzingaro S, Medori R, Lombertie ER. 2005. Sustained improvement of clinical outcome with risperidone long-acting injectable in psychotic patients previously treated with olanzapine. Journal of Psychopharmacology 19(5 Suppl): 32-38.
 
Keith SJ, Pani L, Nick B, Emsley R, San L, Turner M, Conley R, Scully P, Chue PS, Lachaux B. 2004. Practical application of pharmacotherapy with long-acting risperidone for patients with schizophrenia. Psychiatric Services 55(9): 997-1005.

Fleischhacker WW, Eerdekens M, Karcher K, Remington G, Llorca PM, Chrzanowski W, Martin S, Gefvert O. 2003. Treatment of Schizophrenia With Long-Acting Injectable Risperidone: A 12-Month Open-Label Trial of the First Long-Acting Second-Generation Antipsychotic. Journal of Clinical Psychiatry 64(10): 1250-1257.
 
Kane JM, Eerdekens M, Lindenmayer J-P, Keith SJ, Lesem M, Karcher K. 2003. Long-acting injectable risperidone: efficacy and safety of the first longacting atypical antipsychotic. American Journal of Psychiatry 160: 1125-1132.

Diabetes

Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L. 2008. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: A randomised, open-label, non-inferiority study. The Lancet 372(Oct4): 1240-1250.

Rave K, de la Peña A, Tibaldi FS, Zhang L, Silverman B, Hausmann M, Heinemann L, Muchmore DB. 2007. AIR Inhaled Insulin in subjects with chronic obstructive pulmonary disease: pharmacokinetics, glucodynamics, safety, and tolerability. Diabetes Care 30(7): 1777-1782.

Rosenstock J, Nakano M, Silverman BL, Sun B, de la Peña A, Suri A, Muchmore DB. 2007. Comparison of standard (self-directed) versus intensive patient training for the Human Insulin Inhalation Powder (HIIP) Delivery System in patients with type 2 diabetes: Efficacy, safety, and training measures. Diabetes Technology & Therapeutics 9(1): 80-88.

Hayes RP, Nakano M, Muchmore D, Schmitke J. 2007. Effect of standard (self-directed) training versus intensive training for Lilly/Alkermes Human Insulin Inhalation Powder Delivery System on patient-reported outcomes and patient evaluation of the system. Diabetes Technology & Therapeutics 9(1): 89-98.

Garg S, Rosenstock J, Silverman BL, Sun B, Konkoy CS, de la Peña A, Munchmore DB. 2006. Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes. Diabetologia 49(5): 891-899.

Rave KM, Nosek L, de la Peña A, Seger M, Ernest CS, Heinemann L, Batycky RP, Muchmore DB. 2005. Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin Lispro. Diabetes Care 28: 2400-2405.

Technology

Edwards DA. 2002. Delivery of biological agents by aerosols. AIChE Journal 48(1): 2-6.

Bartus RT, Tracy MA, Emerich DF, Zale SE. 1998. Sustained delivery of proteins for novel therapeutic products. Science 281: 1161-1162.

Edwards DA, Ben-Jebria A, Langer R. 1998. Recent advances in pulmonary drug delivery using large, porous inhaled particles. Journal of Applied Physiology 84(2): 379-385.

Herbert P, Murphy K, Johnson O, Dong N, Jaworowicz W, Tracy MA, Cleland JL, Putney SD. 1998. A large-scale process to produce microencapsulated proteins. Pharmaceutical Research 15(2): 357-361.

Putney SD and Burke PA. Improving protein therapeutics with sustained-release formulations. 1998. Nature Biotechnology 16: 153-157.

Edwards DA, Hanes J, Caponetti G, Hrkach J, Ben-Jebria A, Eskew ML, Mintzes J, Deaver D, Lotan N, Langer R. 1997. Large porous particles for pulmonary drug delivery. Science 276: 1868-1871.