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\r\n To report SUSPECTED ADVERSE REACTIONS, contact Collegium\r\n Pharmaceutical, Inc. at 1-855-331-5615 or FDA at\r\n 1-800-FDA-1088 or www.fda.gov/medwatch.\r\n
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\r\n \r\n Please see Important Safety Information and Full Prescribing\r\n Information including Boxed Warning on Abuse, Misuse, and\r\n Addiction and other serious risks, at\r\n JORNAYPM-pro.com/pi\r\n \r\n
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\r\n References: 1. JORNAY PM® [package\r\n insert]. Ironshore Pharmaceuticals & Development, Inc.\r\n 2. Childress AC, Cutler AJ, Marraffino A, et al. A\r\n randomized, double-blind, placebo-controlled study of\r\n HLD200, a delayed-release and extended-release\r\n methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder: an evaluation of\r\n safety and efficacy throughout the day and across settings.\r\n J Child Adolesc Psychopharmacol. 2020;30(1):2-14.\r\n doi:10.1089/cap.2019.0070 3. Pliszka SR, Wilens TE,\r\n Bostrom S, et al. Efficacy and safety of HLD200,\r\n delayed-release and extended-release methylphenidate, in\r\n children with attention-deficit/hyperactivity disorder.\r\n J Child Adolesc Psychopharmacol. 2017;27(6):474-482.\r\n doi:10.1089/cap.2017.0084 4. Incledon B, Incledon C,\r\n Gomeni R, et al. Effect of colonic absorption on the\r\n pharmacokinetic properties of delayed-release and\r\n extended-release methylphenidate: in vivo, in vitro, and\r\n modeling evaluations. Clin Pharmacol Drug Dev.\r\n 2022;11(8):966-975. doi:10.1002/cpdd.1089 5. Po M,\r\n Gomeni R, Incledon B. Quantitative characterization of the\r\n smoothness of extended-release methylphenidate\r\n pharmacokinetic profiles. Innov Clin Neurosci.\r\n 2022;19(7-9):32-37. 6. Gomeni R, Komolova M,\r\n Incledon B, Faraone SV. Model-based approach for\r\n establishing the predicted clinical response of a\r\n delayed-release and extended-release methylphenidate for the\r\n treatment of attention-deficit/hyperactivity disorder.\r\n J Clin Psychopharmacol. 2020;40(4):350-358.\r\n doi:10.1097/JCP.0000000000001222 7. Mercalis, data as\r\n of February 25, 2025.\r\n 8. Data on File. Collegium Pharmaceutical. 2025.\r\n
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\r\n References: 1. Childress AC, Cutler AJ, Marraffino\r\n A, et al. A randomized, double-blind, placebo-controlled\r\n study of HLD200, a delayed-release and extended-release\r\n methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder: an evaluation of\r\n safety and efficacy throughout the day and across settings.\r\n J Child Adolesc Psychopharmacol. 2020;30(1):2-14.\r\n doi:10.1089/cap.2019.0070 2. JORNAY PM®\r\n [package insert]. Ironshore Pharmaceuticals & Development,\r\n Inc. 3. Katzman MA, Otcheretko V, Po MD, Uchida CL,\r\n Incledon B. Adverse events during dosing of\r\n delayed-release/extended-release methylphenidate: learnings\r\n from the open-label phase of a registration trial and a\r\n real-world postmarketing surveillance program.\r\n Clin Ther. 2023;45(12):1212-1221.\r\n doi:10.1016/j.clinthera.2023.09.009\r\n 4. Pliszka SR, Wilens TE, Bostrom S, et al.\r\n Efficacy and safety of HLD200, delayed-release and\r\n extended-release methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder.\r\n J Child Adolesc Psychopharmacol. 2017;27(6):474-482.\r\n doi:10.1089/cap.2017.0084 5. Mercalis, data\r\n as of February 25, 2025. 6. Data on File.\r\n Collegium Pharmaceutical. 2025.\r\n
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\r\n References: 1. JORNAY PM® [package\r\n insert]. Ironshore Pharmaceuticals & Development, Inc.\r\n 2. Childress AC, Cutler AJ, Marraffino A,\r\n et al. A randomized, double-blind, placebo-controlled study\r\n of HLD200, a delayed-release and extended-release\r\n methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder: an evaluation of\r\n safety and efficacy throughout the day and across settings.\r\n J Child Adolesc Psychopharmacol. 2020;30(1):2-14.\r\n doi:10.1089/cap.2019.0070 3. Data on File.\r\n Collegium Pharmaceutical. 2025.\r\n
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\r\n \r\n References: 1. JORNAY PM® [package\r\n insert]. Ironshore Pharmaceuticals & Development, Inc.\r\n 2. Childress AC, Cutler AJ, Marraffino A, et al. A\r\n randomized, double-blind, placebo-controlled study of\r\n HLD200, a delayed-release and extended-release\r\n methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder: an evaluation of\r\n safety and efficacy throughout the day and across settings.\r\n J Child Adolesc Psychopharmacol. 2020;30(1):2-14.\r\n doi:10.1089/cap.2019.0070 3. Pliszka SR, Wilens TE,\r\n Bostrom S, et al. Efficacy and safety of HLD200,\r\n delayed-release and extended-release methylphenidate, in\r\n children with attention-deficit/hyperactivity disorder.\r\n J Child Adolesc Psychopharmacol. 2017;27(6):474-482.\r\n doi:10.1089/cap.2017.0084\r\n\r\n 4. Wigal SB, Gupta S, Guinta D, Swanson JM.\r\n Reliability and validity of the SKAMP rating scale in a\r\n laboratory school setting. Psychopharmacol Bull.\r\n 1998;34(1):47-53.\r\n\r\n 5. Kelsey DK, Summer CR, Casat CD, et al. Once-daily\r\n atomoxetine treatment for children with\r\n attention-deficit/hyperactivity disorder, including an\r\n assessment of evening and morning behavior: a double-blind,\r\n placebo-controlled trial. Pediatrics.\r\n 2004;114(1):e1-e8. doi:10.1542/peds.114.1.e1\r\n\r\n 6. Faraone SV, DeSousa NJ, Komolova M, Sallee FR,\r\n Incledon B, Wilens TE. Functional impairment in youth with\r\n ADHD: normative data and norm-referenced cutoff points for\r\n the Before School Functioning Questionnaire and the Parent\r\n Rating of Evening and Morning Behavior Scale, Revised.\r\n J Clin Psychiatry. 2019;81(1):19m12956.\r\n doi:10.4088/JCP.19m12956\r\n\r\n 7. Data on File. Collegium Pharmaceutical. 2025.\r\n \r\n \r\n \r\n References: 1. Gomeni R, Komolova M, Incledon B,\r\n Faraone SV. Model-based approach for establishing the\r\n predicted clinical response of a delayed-release and\r\n extended-release methylphenidate for the treatment of\r\n attention-deficit/hyperactivity disorder.\r\n J Clin Psychopharmacol. 2020;40(4):350-358. doi:10.1097/JCP.0000000000001222\r\n 2. Incledon B, Incledon C, Gomeni R, et al. Effect of\r\n colonic absorption on the pharmacokinetic properties of\r\n delayed-release and extended-release methylphenidate: in\r\n vivo, in vitro, and modeling evaluations.\r\n Clin Pharmacol Drug Dev. 2022;11(8):966-975.\r\n doi:10.1002/cpdd.1089 3. Po M, Gomeni R, Incledon B.\r\n Quantitative characterization of the smoothness of\r\n extended-release methylphenidate pharmacokinetic profiles.\r\n Innov Clin Neurosci. 2022;19(7-9):32-37.\r\n\r\n 4. Childress AC, Cutler AJ, Marraffino A, et al. A\r\n randomized, double-blind, placebo-controlled study of\r\n HLD200, a delayed-release and extended-release\r\n methylphenidate, in children with\r\n attention-deficit/hyperactivity disorder: an evaluation of\r\n safety and efficacy throughout the day and across settings.\r\n J Child Adolesc Psychopharmacol. 2020;30(1):2-14.\r\n doi:10.1089/cap.2019.0070 5. Gomeni R, Tan DT, Sallee\r\n RF, Incledon B. A model-based pharmacokinetic comparison of\r\n delayed-release/extended release to extended-release\r\n methylphenidates with immediate-release supplementation.\r\n Poster presented at: American Professional Society of ADHD\r\n and Related Disorders (APSARD) Annual Meeting; January\r\n 15-17, 2021; Virtual.\r\n \r\n
\r\n\r\n \r\n References: 1. Mercalis, data as of February 25,\r\n 2025. 2. Data on File. Collegium\r\n Pharmaceutical. 2025.\r\n \r\n\r\n \r\n References: 1. Mercalis, data as of February 25,\r\n 2025. 2. Data on File. Collegium\r\n Pharmaceutical. 2025.\r\n \r\n \r\n ![\"Close\"](\"@/assets/img/cookie-component/closeBtn.svg\")
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