Beyond the pill: new medication delivery options for ADHD

Abstract

Successful treatment of pediatric disorders has necessitated the development of alternative medication formulations, as children may prefer alternative dosage forms to tablets or capsules. This is especially true for attention-deficit/hyperactivity disorder (ADHD), which is one of the most common chronic pediatric conditions and often involves children with a variety of overlapping physical, psychological, or neurodevelopmental disorders. A special challenge for developing alternative dosage forms for ADHD treatment is the incorporation of a once-daily long-acting formulation. Traditional ADHD medication formulations have been limited, and issues surrounding prescribed dosing regimens-including poor medication adherence, difficulty swallowing, and the lack of dosing titration options-persist in ADHD treatment. In other disease areas, the development of alternative formulations has provided options for patients who have issues with consuming solid dosage forms, particularly children and individuals with developmental disorders. In the light of these new developments, several alternative formulations for ADHD medications are under development or have recently become available. This article reviews the various strategies for developing alternative dosage forms in other disease areas and discusses the application of these strategies in ADHD treatment. Alternative dosage forms may increase medication adherence, compliance, and patient preference and, therefore, improve the overall treatment for ADHD.

Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial

“…14,38,58 Furthermore, current formulations of nonstimulant ADHD medications as solid tablets or capsules that cannot be sprinkled over food may preclude their use in children who experience difficulty swallowing or who prefer not to take pills (eg, individuals with autism, sensory processing disorder, or other developmental disabilities). 37 Considering the complexity of ADHD and the potential tolerability-related limitations of currently available FDA-approved medications noted earlier, new effective treatment options with diminished risk could improve the management of this common neurodevelopmental disorder.…”

“…34e36 In addition, currently available nonstimulant ADHD medications are formulated as solid tablets or capsules, which poses a potential challenge for children who experience difficulty with swallowing or who prefer not to take pills (eg, children with autism, sensory processing disorder, or other developmental disabilities). 37 There may be various reasons for low efficacy or tolerability of the currently available FDA-approved medications for ADHD, including complexity of the condition itself, high rates of comorbid psychiatric disorders, and difficulties with regimen or dose optimization. 38 More treatment options are clearly needed for those patients in whom current prescription therapies offer inadequate benefit or are precluded due to tolerability issues or patient/ caregiver preferences.…”

Impact of a High-Fat Meal and Sprinkled Administration on the Bioavailability and Pharmacokinetics of Viloxazine Extended-Release Capsules (QelbreeTM) in Healthy Adult Subjects

“…As it is a developmental disorder, treatment for ADHD usually occurs over the long term (e.g., over months or years) [ 1 ], presenting numerous opportunities for treatment nonadherence when medications have to be taken daily (or several times a day in the case of medium- or short-acting stimulants) [ 21 , 22 ]. Alternative formulations such as liquids, chewables, or transdermal patches are relatively uncommon among ADHD treatments [ 13 ], limiting the clinician’s armamentarium considerably.…”

“…As a result, they are generally inadvisable for most ADHD medications, particularly sustained, controlled, extended, or long-acting release drug formulations that may rely on coatings, beads, or other technologies to control drug absorption, metabolism, and exposure [38,41]. The pharmacokinetics of several stimulant ADHD medications have been shown to be unaffected when administered as a sprinkle compared to an intact capsule [13,38]. Notably, this is not the case for the nonstimulant ADHD drugs atomoxetine and guanfacine XR, as their prescribing information currently advises that they be consumed intact [11,12].…”

“…A major treatment challenge for many children (and, to a lesser extent, adults) is the inability to swallow pills or an aversion to doing so, particularly with persistent disorders such as ADHD, for which treatment may last months or years [8][9][10]. While some new drug formulations have resulted in liquids, sublinguals, or transdermal patches, the majority of ADHD medications (including the Food and Drug Administration [FDA]approved nonstimulants atomoxetine [11] and guanfacine extended-release [XR] [12]) are available only in tablet or capsule form [13]. Particularly in the case of extended, delayed, or controlled-release formulations, modifying drug delivery by sprinkling, chewing, or crushing pills to facilitate consumption can change a medication's pharmacokinetic profile, with potentially serious clinical effects [14][15][16].…”