NDAORALCAPSULE, EXTENDED RELEASE
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
4/8 — Partial
ADHANSIA XR (methylphenidate hydrochloride) by Purdue Pharma is (cns) stimulant. First approved in 2019.
Drug data last refreshed 13h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADHANSIA XR is an extended-release oral capsule formulation of methylphenidate hydrochloride, a CNS stimulant approved by FDA in 2019. It is indicated for ADHD treatment and works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing monoamine availability in the extraneuronal space. The mechanism of therapeutic action in ADHD is not fully elucidated despite decades of clinical use.
Peak12.2 years to LOE
Product is at peak commercial stage with robust patent protection through 2038, suggesting stable team headcount and established go-to-market infrastructure.
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of inin ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
Started Aug 2021
103 enrolled
Attention Deficit/Hyperactivity Disorder
Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Started Jul 2020
267 enrolled
Attention-Deficit/Hyperactivity Disorder
A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity
Started Apr 2019
60 enrolled
Attention Deficit Hyperactivity DisorderGeneralized Anxiety DisorderSocial Anxiety Disorder+2 more
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Started Apr 2011
299 enrolled
Attention Deficit/Hyperactivity Disorder
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Started Nov 2010
725 enrolled
Attention Deficit/Hyperactivity Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.