CLINICAL TRIALS PROFILE FOR LAZANDA

All Clinical Trials for LAZANDA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01756651 ↗	Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures	Completed	Depomed	Phase 1	2013-02-01	The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.
NCT01756651 ↗	Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures	Completed	Richard C Reznichek, MD	Phase 1	2013-02-01	The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.
NCT01812759 ↗	Fentanyl for Breakthrough Pain in the Emergency Department	Terminated	Archimedes Pharma US, Inc.	Phase 4	2014-01-10	The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department. In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect. You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.
NCT01812759 ↗	Fentanyl for Breakthrough Pain in the Emergency Department	Terminated	M.D. Anderson Cancer Center	Phase 4	2014-01-10	The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department. In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect. You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.
NCT01839552 ↗	An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.	Withdrawn	James Graham Brown Cancer Center	Phase 4	2014-10-01	Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking other opioid pain medicines and the patient's body has become used to them (opioid tolerant). The purpose of this study is to assess the ability of Lazanda to control pain during an episode of breakthrough pain in cancer patients.

Clinical Trial Conditions for LAZANDA

Condition Name

Condition Name for LAZANDA
Intervention	Trials
Pain	2
Bone Metastases	1
Minor Procedural Pain	1
Other Acute Pain	1

Condition MeSH

Condition MeSH for LAZANDA
Intervention	Trials
Emergencies	1
Acute Pain	1
Neoplasm Metastasis	1
Pain, Procedural	1

Clinical Trial Locations for LAZANDA

Trials by Country

Trials by Country for LAZANDA
Location	Trials
United States	5

Trials by US State

Trials by US State for LAZANDA
Location	Trials
California	2
North Carolina	1
Kentucky	1
Texas	1

Clinical Trial Progress for LAZANDA

Clinical Trial Phase

Clinical Trial Phase for LAZANDA
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for LAZANDA
Clinical Trial Phase	Trials
Completed	2
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for LAZANDA

Sponsor Name

Sponsor Name for LAZANDA
Sponsor	Trials
Depomed	2
James Graham Brown Cancer Center	2
University of Louisville	2

Sponsor Type

Sponsor Type for LAZANDA
Sponsor	Trials
Other	9
Industry	3

LAZANDA (fentanyl buccal soluble film): Clinical trials update, market analysis, and projections

Last updated: May 2, 2026

LAZANDA (fentanyl) is a prescription, opioid analgesic delivered as a buccal soluble film for breakthrough cancer pain in adults already receiving opioid therapy. Commercial demand is tied to cancer pain treatment volumes, opioid stewardship policies, payer controls on opioid access, and safety-driven label and utilization management. Below is a market and trial-focused view using publicly available regulatory and commercial artifacts.

What is LAZANDA and what is its approved clinical use profile?

LAZANDA is approved for:

• Indication: Treatment of breakthrough cancer pain (BTCP) in adult patients who are already receiving and tolerant to opioid therapy for their persistent cancer pain (U.S. label context).
• Core concept: rapid-onset fentanyl therapy delivered via buccal absorption (buccal soluble film).

Regulatory artifacts for U.S. label scope (and any label changes) drive usage rules for oncology/pain clinics and payers.

Commercial implication: the addressable population is narrower than general cancer pain. It excludes opioid non-tolerant patients and shifts volume with oncology care models (especially where BTCP management uses alternatives such as oral immediate-release opioids, transmucosal systems, or parenteral rescue).

What is the clinical trials update for LAZANDA?

Evidence base status (trial activity screen)

LAZANDA’s clinical development center historically on demonstrating fentanyl exposure and on BTCP response in opioid-tolerant cancer patients. Post-approval activity in the public domain commonly consists of:

• Supportive pharmacokinetic (PK) work and formulation/administration bridge studies.
• Safety and risk management aligned with the opioid class.
• Comparator or switching studies in clinical practice research settings.

What tends to move the needle in post-approval trials for fentanyl BTCP assets

For a marketed fentanyl BTCP product, the commercial outcome of new clinical programs tends to depend less on expanding the indication and more on:

• Dose range refinement and titration methodologies that reduce discontinuation.
• Administration usability outcomes that drive persistence and reduced misuse.
• Risk minimization compliance in real-world settings.

Data limitation constraint

A complete, up-to-date “clinical trials update” requires current trial registries and publication listings (e.g., ClinicalTrials.gov records, journal trial reports, and sponsor updates) for the last 24 months. Those registry reads are not available in the prompt’s provided source corpus. Under this constraint, no authoritative trial-by-trial update can be produced without fabricating activity.

What is the market landscape for LAZANDA?

Competitive set

LAZANDA sits in the transmucosal fentanyl BTCP segment where brands compete primarily on:

• Rapidity of onset and perceived effectiveness versus onset timing needs
• Dosing flexibility and titration convenience
• Payer policy position and prior authorization patterns
• Formulation and administration usability

Key demand drivers

LAZANDA demand is shaped by:

1. Oncology volumes and BTCP prevalence

   • BTCP is common among patients with active cancer pain.
   • The pool is still “opioid-tolerant” constrained.

2. Opioid stewardship and payer management

   • Managed care uses step edits, prior authorization, quantity limits, and opioid education requirements for high-risk agents.

3. Safety events and class-level monitoring

   • The fentanyl class is subject to ongoing regulatory scrutiny, prescriber controls, and REMS-adjacent practices.

4. Interchangeability within BTCP therapy

   • Clinicians often switch among BTCP options based on access, insurance coverage, and patient response.

Pricing and access dynamics (high level)

LAZANDA, as a brand opioid product, typically experiences:

• Utilization pressure from payer edits and generic/alternative uptake in related formulations.
• Net price discounts in commercial channels tied to volume and rebate structures.

A precise market share view requires source reads for IQVIA/DRG/claims and payer contract data, which are not provided in the prompt’s corpus.

How should LAZANDA market projection be modeled?

Without live trial/claims inputs, the only defensible projections are mechanistic scenario models anchored on structural drivers (BTCP eligibility, payer restrictiveness, and competitive switching). The model below is designed for investment or R&D sizing and uses clear levers.

Projection framework (scenario-based)

Base-case volume growth/decline for LAZANDA typically tracks:

• Addressable population change (cancer incidence and opioid-tolerant proportion)
• BTCP therapy adoption rate
• Share-of-voice in payer formularies
• Switching drag due to competitor coverage and patient response
• Discontinuation and safety-driven caution

Scenario levers (what moves revenue)

Lever	Mechanism	Upside scenario effect	Downside scenario effect
Payer access	formulary placement, prior auth frequency, PA criteria complexity	higher fill rates	restricted access, more denials
BTCP patient mix	proportion of patients who meet “opioid tolerant” criteria	more eligible volume	fewer eligible patients or more therapy switching
Competitive switching	efficacy perception, administration fit, coverage changes	LAZANDA remains first-line BTCP rescue	share loss to alternative BTCP products
Safety/label utilization changes	risk controls, REMS-adjacent practice changes	stable prescribing behavior	increased caution leads to underuse

What to avoid in projections

• Any forecast that assumes LAZANDA gains broad indication scope without an evidence record.
• Any forecast that treats total BTCP market as fully capturable without accounting for opioid-tolerant eligibility constraints.

What are the R&D implications for LAZANDA now?

Even when formal registrational trials do not expand the label, fentanyl BTCP products can protect revenue and margin through:

• Next-generation administration improvements to reduce barrier to use
• Dose optimization approaches that reduce early discontinuations and dosing errors
• Real-world evidence programs that align with payer requirements for opioid safety and appropriate use

A practical R&D decision should be tied to one of two outcomes: label expansion (rare for this class) or payer-facing evidence that improves formulary positioning.

Key Takeaways

• LAZANDA is a fentanyl buccal soluble film for breakthrough cancer pain in opioid-tolerant adults, so demand is constrained by eligibility and payer controls.
• Market performance is driven more by access and switching behavior than by clinical differentiation alone in a crowded BTCP fentanyl landscape.
• A defendable projection requires scenario modeling around payer access, BTCP eligibility mix, and competitive coverage, not a broad “total BTCP market capture” assumption.
• A true “clinical trials update” requires live registry and publication sourcing that is not present in the provided material set; no trial-by-trial update can be stated without fabrication.

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FAQs

1) Is LAZANDA indicated for non-cancer pain?

LAZANDA is indicated for breakthrough cancer pain in adult patients who are already receiving and tolerant to opioid therapy for persistent cancer pain. It is not positioned for general non-cancer pain in the approved BTCP use context.

2) What makes LAZANDA’s addressable population smaller than general opioid markets?

The approved patient set is opioid-tolerant adults with cancer breakthrough pain, which limits demand versus broader opioid indications.

3) What typically drives utilization changes for fentanyl BTCP products?

Payer placement and authorization rules, plus real-world switching among BTCP alternatives based on coverage and patient response, usually drive utilization more than incremental clinical trial headlines.

4) Are new clinical trials likely to expand the LAZANDA label?

Class-wide opioid BTCP agents rarely see rapid indication expansion absent new registrational efficacy/safety evidence. Most post-approval work is supportive rather than label-broadening.

5) What inputs matter most for LAZANDA revenue projections?

The highest-leverage inputs are payer access (fill rates), patient eligibility mix (opioid tolerance proportions), and share displacement from competing BTCP products.

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References

[1] U.S. Food and Drug Administration. LAZANDA (fentanyl) prescribing information and labeling documentation.