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A Different Way to Dose Starting and optimizing treatment

With 5 different dosing strengths, JORNAY PM gives you the flexibility to adjust the duration of ADHD symptom control¹

In Pivotal Study 1, 98% of patients were titrated to and optimized at doses above 20 mg/day at the end of the dose-optimization phase⁵

Recommended starting dose is 20 mg/day taken each evening.¹ See Mechanism of Action
Initiate dose at 8 PM. Adjust the timing of administration between 6:30 PM and 9:30 PM to optimize efficacy and tolerability the next morning and throughout the day. Maintain a consistent dosing time¹
Dose may be titrated weekly in increments of 20 mg/day to a maximum daily dose of 100 mg/day¹
Relative bioavailability of methylphenidate in JORNAY PM is ~75%⁸
In Pivotal Study 1, the mean final dose at Week 6 was 66.2 mg/day²
Consider whether titration to a higher dose is necessary to achieve continued efficacy through the evening¹

IMPORTANT SAFETY INFORMATION (CONTINUED) WARNINGS AND PRECAUTIONS (CONTINUED)

JORNAY PM can cause serious adverse reactions and patients should be monitored for the following:

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Observe patients for digital changes during treatment.
Weight Loss and Long-Term Suppression of Growth in Pediatric Patients: Monitor height and weight.

Please see Important Safety Information and Full Prescribing Information, including Boxed Warning.

References

References: 1. JORNAY PM^® [package insert]. Ironshore Pharmaceuticals & Development, Inc. 2. Childress AC, Cutler AJ, Marraffino A, et al. A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: an evaluation of safety and efficacy throughout the day and across settings. J Child Adolesc Psychopharmacol. 2020;30(1):2-14. 3. Pliszka SR, Wilens TE, Bostrom S, et al. Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2017;27(6):474-482. 4. Gomeni R, Komolova M, Incledon B, Faraone SV. Model-based approach for establishing the predicted clinical response of a delayed-release and extended-release methylphenidate for the treatment of attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2020;40(4):350-358. 5. Childress AC, Uchida CL, Po MD, DeSousa NJ, Incledon B. A post hoc comparison of prior ADHD medication dose and optimized delayed-release and extended-release methylphenidate dose in a pivotal phase III trial. Clin Ther. 2020;42(12):2332-2340. 6. Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B. Single-dose pharmacokinetics of HLD200, a delayed-release and extended-release methylphenidate formulation, in healthy adults and in adolescents and children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2018;28(1):10-18. 7. Gomeni R, Tan D, Sallee R, Incledon B. A model-based pharmacokinetic comparison of delayed-release/extended-release methylphenidate to extended-release methylphenidates with immediate-release supplementation. Poster presented at: The American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting; January 15-17, 2021. 8. Liu T, Gobburu JVS, Po MD, et al. Pharmacokinetics of HLD200, a delayed-release and extended-release methylphenidate: evaluation of dose proportionality, food effect, multiple-dose modeling, and comparative bioavailability with immediate-release methylphenidate in healthy adults. J Child Adolesc Psychopharmacol. 2019;29(3):181-191. 9. Katzman A, Otcheretko V, Po M, et al. Adverse events during dosing of delayed-release/extended-release methylphenidate: learnings from the open-label phase of a registration trial and a real-world postmarketing surveillance program. Clin Ther. 2023;45:1212-1221. 10. Faraone SV, DeSousa NJ, Komolova M, et al. Functional impairment in youth with ADHD: normative data and norm-referenced cutoff points for the Before School Functioning Questionnaire and the Parent Rating of Evening and Morning Behavior Scale, Revised. J Clin PsychiatryJ. 2020;81(1):19m12956. 11. APTENSIO XR [package insert]. Rhodes Pharmaceuticals; 2019. 12. AZSTARYS [package insert]. Corium, Inc.; 2021. 13. CONCERTA [package insert]. Janssen Pharmaceuticals, Inc.; 2021. 14. COTEMPLA XR-ODT [package insert]. Aytu BioPharma, Inc.; 2023. 15. FOCALIN XR [package insert]. Novartis Pharmaceuticals Corporation; 2021. 16. METADATE CD [package insert]. UCB, Inc.; 2013. 17. METADATE ER [package insert]. UCB, Inc.; 2014. 18. QUILLIVANT XR [package insert]. NextWave Pharmaceuticals, Inc.; 2021. 19. QUILLICHEW ER [package insert]. NextWave Pharmaceuticals, Inc.; 2021. 20. RITALIN LA [package insert]. Novartis Pharmaceuticals Corporation; 2021. 21. ADZENYS XR-ODT [package insert]. Aytu BioPharma, Inc.; 2022. 22. ADDERALL XR [package insert]. Shire US Inc.; 2013. 23. DEXEDRINE [package insert]. GlaxoSmithKline; 2007. 24. DYANAVEL XR [package insert]. Tris Pharma Inc.; 2022. 25. MYDAYIS [package insert]. Takeda Pharmaceuticals U.S.A., Inc.; 2022. 26. VYVANSE [package insert]. Takeda Pharmaceuticals U.S.A., Inc.; 2022. 27. Incledon B, Incledon C, Gomeni R, et al. Effect of colonic absorption on the pharmacokinetic properties of delayed-release and extended-release methylphenidate: in vivo, in vitro, and modeling evaluations. Clin Pharm Drug Dev. 2022;11(8):966-975. 28. Data on file. HLD200-108; Ironshore Pharmaceuticals & Development, Inc.; 2016. 29. Data on file. HLD200-107; Ironshore Pharmaceuticals & Development, Inc.; 2016. 30. Wigal SB, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull. 1998;34(1):47-53. 31. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R. ADHD Rating Scale-IV: Checklists, norms, and clinical interpretation. New York: Guilford; 1998.