CLINICAL TRIALS PROFILE FOR ABSTRAL

All Clinical Trials for ABSTRAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01158820 ↗	Alternative Sedation During Bronchoscopy	Completed	Hospira, Inc.	Phase 4	2010-06-01	This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
NCT01158820 ↗	Alternative Sedation During Bronchoscopy	Completed	Hospira, now a wholly owned subsidiary of Pfizer	Phase 4	2010-06-01	This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
NCT01158820 ↗	Alternative Sedation During Bronchoscopy	Completed	University of Pennsylvania	Phase 4	2010-06-01	This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
NCT01315886 ↗	Conversion From Fast Acting Oral Opioids to Abstral®	Terminated	Orexo AB	Phase 4	2011-02-21	The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
NCT01604187 ↗	Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients	Completed	Turku University Hospital	Phase 4	2012-04-01	Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009). Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.
NCT01936636 ↗	Observational Registry Study of Quality of Life When Treating BTcP With Abstral	Completed	Galena Biopharma, Inc.		2013-10-01	This Observational Registry study is designed to collect self-reported Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.
NCT03080324 ↗	Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room	Completed	Azienda Sanitaria dell'Alto Adige	Phase 4	2016-12-01	The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.

Clinical Trial Conditions for ABSTRAL

Condition Name

Condition Name for ABSTRAL
Intervention	Trials
Acute Pain Due to Trauma	2
Pain	2
Breakthrough Cancer Pain	1
Colonoscopy	1

Condition MeSH

Condition MeSH for ABSTRAL
Intervention	Trials
Acute Pain	2
Wounds and Injuries	2
Cancer Pain	1
Breakthrough Pain	1

Clinical Trial Locations for ABSTRAL

Trials by Country

Trials by Country for ABSTRAL
Location	Trials
United States	19
Italy	2
Sweden	1
Finland	1

Trials by US State

Trials by US State for ABSTRAL
Location	Trials
Texas	2
Pennsylvania	2
Washington	1
Tennessee	1
Rhode Island	1

Clinical Trial Progress for ABSTRAL

Clinical Trial Phase

Clinical Trial Phase for ABSTRAL
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1

Clinical Trial Status

Clinical Trial Status for ABSTRAL
Clinical Trial Phase	Trials
Completed	5
Recruiting	1
Terminated	1

Clinical Trial Sponsors for ABSTRAL

Sponsor Name

Sponsor Name for ABSTRAL
Sponsor	Trials
Azienda Sanitaria dell'Alto Adige	2
Galena Biopharma, Inc.	1
Institute of Mountain Emergency Medicine	1

Sponsor Type

Sponsor Type for ABSTRAL
Sponsor	Trials
Other	6
Industry	4
NIH	1

Abstral (fentanyl) clinical trials update, market analysis, and exclusivity-driven revenue projection

Last updated: July 28, 2026

Abstral is an oral transmucosal fentanyl citrate (OTFC) product indicated for breakthrough pain in opioid-tolerant adults with cancer. Its market outlook is constrained by (1) heavy class-level competition among OTFC and fentanyl generics, (2) payer and guideline pressure to use managed opioid strategies, and (3) patent and exclusivity maturity that typically shifts pricing power toward settled generic and authorized-OTFC supply.

What patents protect Abstral, and when do exclusivities expire?
Abstral’s intellectual property estate is not evaluated here because no jurisdiction-specific patent and Orange Book listing set is provided in the input. Without the exact Orange Book product code, NDA/BLA identifier, and the patent list (US patents tied to the specific listed drug and dosage form), an accurate expiration timeline and Paragraph IV risk map cannot be produced.

What formulations are protected by Abstral patents?

For OTFC brands, patent coverage usually clusters into:

• fentanyl citrate composition/salt and particle properties
• transmucosal delivery technology and dosing unit manufacturing
• method-of-use for breakthrough cancer pain in opioid-tolerant adults
• process patents for producing the dosage form

A formulation-to-patent mapping cannot be completed without the listed Orange Book patent numbers tied to Abstral’s NDA and strengths.

When does Abstral lose exclusivity?

A credible exclusivity timeline requires:

• FDA Orange Book “expiration” and “exclusivity start/end” fields for Abstral’s NDA
• any pediatric exclusivity extensions, orphan-related exclusivity (if any), and patent-term adjustments

Those fields are not included in the input, so no dates can be asserted.

What clinical trials have been conducted for Abstral, and what is the latest update?
A clinical-trials update requires the most recent recordable milestones (latest cut of CT.gov, EMA clinical register, and submission supplements), with dates and primary endpoints. The input does not include trial IDs, sponsors, or update dates, so no “latest” claim can be produced.

Which endpoints matter in Abstral development and postmarketing trials?

For OTFC products used in breakthrough cancer pain, trial endpoints typically include:

• time to onset of analgesia
• proportion achieving meaningful pain relief (e.g., “responder” definitions)
• pain intensity scores over a fixed post-dose window
• duration of analgesia and rescue medication use
• safety signals: respiratory depression, sedation, hypotension, misuse risk
• population PK and exposure-response in opioid-tolerant adults

A trial-by-trial update cannot be compiled without the underlying dataset.

Does Abstral have subpopulation or long-term safety studies?

OTFC brands sometimes run:

• repeated-dose safety studies
• opioid-tolerant demographic stratification
• abuse-deterrence-related evaluation
• usability and handling (buccal/oral mucosa adherence) studies

No trial registry specifics are provided in the input.

How does Abstral compare with other oral transmucosal fentanyl products (OTFC)?
Abstral competes in the OTFC category against other fentanyl transmucosal delivery systems (and, where available, authorized generics or equivalent products). The competitive question turns on:

• formulary positioning at major PBMs
• patient preference and tolerability
• dosing flexibility and onset profile within label-defined use
• net pricing and rebates in managed care

A quantitative competitive comparison cannot be produced without at least one of the following in the input: IMS/IQVIA volume or sales figures by SKU, payer/formulary access data, or publicly disclosed net revenue by manufacturer.

What is the competitive landscape risk for Abstral?

For mature OTFC products, the main revenue risks usually come from:

• generic or lower-priced equivalents entering and taking share
• formulary tightening after safety communications and opioid policy shifts
• shifts toward alternative breakthrough pain strategies
• substitution under pharmacy benefit rules

No manufacturer revenue trend lines or market share baselines are provided in the input.

What is the Orange Book status of Abstral?
Orange Book status requires:

• NDA number
• “Listed Drug” identity (strengths, dosage form)
• patent list: US patent numbers, claims, expiration dates, and status (expired, active, withdrawn)
• exclusivity: non-patent exclusivity expiration

No Orange Book data is provided in the input. Therefore, Orange Book status cannot be stated.

When do generics or biosimilars risk Abstral, and what are Paragraph IV entry scenarios?
Abstral is a small-molecule fentanyl product, so biosimilars are not the relevant risk class. The risk is generic entry via ANDA pathways, including potential Paragraph IV challenges tied to listed patents.

A Paragraph IV risk model requires:

• active Orange Book patents and expected expiration
• any ANDA/Paragraph IV filings and lawsuit dockets (FDA 180-day exclusivity, 505(j) filings)
• settlement agreements that affect launch timing

No litigation, FDA filing events, or patent list is provided in the input.

How strong is the patent estate for Abstral, and what is the generic launch barrier?
Patent-strength assessment needs:

• claim scope granularity (composition vs method-of-use vs process)
• prosecution history, examiner amendments, and narrowing
• remaining active claim term length and enforceability
• litigation record and PTAB challenges

Without the specific Abstral patent set, a strength scoring cannot be produced.

What patent litigation affects Abstral?
Litigation update requires court case numbers, parties, filing dates, and asserted patent numbers. None are provided in the input, so no litigation summary can be generated.

Market analysis and revenue projection for Abstral: what growth drivers and headwinds matter?
A revenue projection needs a base-year sales number, expected substitution curve, and assumed exclusivity/generic timing. The input includes none of these. A projection can be described only qualitatively at high level:

Growth drivers (typical for OTFC brands)

• continued demand among opioid-tolerant cancer patients
• incremental adoption in institutions with breakthrough pain protocols
• dosing switching from other OTFC products when tolerated better
• brand reinforcements in oncology pain management education

Headwinds (typical for mature OTFC brands)

• share pressure from cheaper equivalents and authorized generics
• payer controls: prior authorization, step edits, quantity limits
• opioid safety risk management and prescriber restrictions
• volume erosion as patients cycle through alternative breakthrough agents
• margin compression from competitive rebates

Projection framework (what to model)

A defensible projection normally models:

• addressable population of opioid-tolerant cancer patients and breakthrough pain prevalence
• treatment persistence and discontinuation rate
• branded-to-generic substitution elasticity over expected launch windows
• gross-to-net effects (rebates, chargebacks, distribution fees)
• competitive take-rate across strengths and dosing regimens

No numeric inputs are provided, so no annual forecast figures can be asserted.

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Key Takeaways

• Abstral is a mature OTFC brand used for breakthrough pain in opioid-tolerant adults with cancer; its outlook is primarily driven by OTCf class competition and substitution dynamics.
• No actionable patent expiration, Orange Book status, litigation events, or latest clinical trial updates can be stated from the provided input.
• A market projection cannot be quantified without base-year revenue, sales trend data, and exclusivity/generic timing inputs tied to Abstral’s specific NDA and listed patents.

FAQs

1. How do OTFC formulary restrictions typically affect Abstral net revenue and volume?
2. What endpoints best predict clinical differentiation among oral transmucosal fentanyl products in opioid-tolerant cancer patients?
3. What is the usual pattern of generic substitution for established fentanyl transmucosal brands after first ANDA launch?
4. Which safety communications and risk-management steps most influence prescribing of OTFC products like Abstral?
5. How do strength-specific demand shifts change forecasting for OTFC products in oncology breakthrough pain?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).
2. ClinicalTrials.gov. (Abstral search results and record history).