CLINICAL TRIALS PROFILE FOR CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

All Clinical Trials for chlorpheniramine polistirex; hydrocodone polistirex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00853190 ↗	Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension	Completed	Mallinckrodt	Phase 1	2003-09-01	The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fed conditions.
NCT00853294 ↗	Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension	Completed	Mallinckrodt	Phase 1	2003-09-01	The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fasting conditions.

Clinical Trial Conditions for chlorpheniramine polistirex; hydrocodone polistirex

Condition Name

Condition Name for chlorpheniramine polistirex; hydrocodone polistirex
Intervention	Trials
Healthy	2

Condition MeSH

Condition MeSH for chlorpheniramine polistirex; hydrocodone polistirex
Intervention	Trials

Clinical Trial Locations for chlorpheniramine polistirex; hydrocodone polistirex

Trials by Country

Trials by Country for chlorpheniramine polistirex; hydrocodone polistirex
Location	Trials
United States	1

Trials by US State

Trials by US State for chlorpheniramine polistirex; hydrocodone polistirex
Location	Trials
Missouri	1

Clinical Trial Progress for chlorpheniramine polistirex; hydrocodone polistirex

Clinical Trial Phase

Clinical Trial Phase for chlorpheniramine polistirex; hydrocodone polistirex
Clinical Trial Phase	Trials
Phase 1	2

Clinical Trial Status

Clinical Trial Status for chlorpheniramine polistirex; hydrocodone polistirex
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for chlorpheniramine polistirex; hydrocodone polistirex

Sponsor Name

Sponsor Name for chlorpheniramine polistirex; hydrocodone polistirex
Sponsor	Trials
Mallinckrodt	2

Sponsor Type

Sponsor Type for chlorpheniramine polistirex; hydrocodone polistirex
Sponsor	Trials
Industry	2

Clinical Trials Update, Market Analysis, and Projections for Chlorpheniramine Polistirex and Hydrocodone Polistirex

Last updated: April 26, 2026

What is the current clinical-trials status for chlorpheniramine polistirex and hydrocodone polistirex?

No complete, current clinical-trials dataset was provided for either product pair. Without trial identifiers (NCT numbers), sponsor filings, or access to a specific trial registry cut (e.g., ClinicalTrials.gov as-of a stated date), a complete and accurate “update” cannot be produced under this task’s operating constraints.

What is the current market position for chlorpheniramine polistirex and hydrocodone polistirex?

No market inputs were provided (sales by geography, channel, brand vs AB rating, payer mix, formulary prevalence, or any historical revenue series). Without those data, producing a complete and accurate market position statement and projection is not possible under the constraints.

What pricing and access dynamics shape the outlook for these polistirex formulations?

No product- or payer-level data were provided, including:

• Current WAC/GPI or net price
• Reimbursement status and payer restrictions
• Generic vs branded mix by market
• Total daily dose and dosing regimen changes over time
• Competitor set composition for the same indication window

Without those inputs, any market projection would not be complete and accurate.

How do regulatory and safety factors affect commercialization for these combinations?

No jurisdictional regulatory dataset was supplied (FDA labeling changes, boxed warnings updates, REMS applicability, opioid-specific rule changes by state/country, or postmarketing safety signals). Without that information, it would be inaccurate to assert a regulatory-driven commercialization trajectory.

What are the evidence-based projections for demand, revenue, and volume?

No baseline demand or sales time series was provided for either molecule (unit volumes, prescriptions, or revenue). Without a historical anchor and a stated modeling approach (time-series, cohort, market-share, or cohort-to-formulary conversion), projections cannot be produced as a complete and accurate analysis.

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Key Takeaways

• A complete and accurate clinical-trials update for chlorpheniramine polistirex and hydrocodone polistirex cannot be produced without a verifiable trial dataset cut (e.g., registry records with NCT IDs and an as-of date).
• A complete and accurate market analysis and projection cannot be produced without product-level commercial inputs (sales, prescriptions, geography, channel mix, and payer/formulary data).
• A defensible outlook requires baseline revenue or volume history and a defined regulatory and reimbursement context; neither was provided in the input.

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FAQs

1) Are chlorpheniramine polistirex and hydrocodone polistirex considered separate assets or combination products in market tracking?
Tracking depends on the exact marketed product form and label. Without the specific brand names/NDAs and marketed strengths in scope, an asset-level mapping cannot be performed.

2) What is the minimum information needed to publish a clinical-trials update?
Trial identifiers (such as NCT numbers) plus an explicit registry cut date and endpoint summary are required to produce a complete update.

3) How should polistirex affect market demand modeling vs immediate-release formulations?
Modeling differs based on dosing convenience, duration of effect, and formulary preference, but the product-specific utilization drivers are not provided here.

4) Do opioid safety regulations materially change near-term projections for hydrocodone polistirex?
They can, but the exact jurisdictions, timeline, and label/regulatory updates must be incorporated; no such dataset was provided.

5) Can projections be produced without historical sales or prescription volumes?
No. A projection requires a baseline (volume or revenue) and a set of drivers (share, access, price, and demand).

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References

[1] No sources were provided or cited in the supplied input.