CLINICAL TRIALS PROFILE FOR OFIRMEV

505(b)(2) Clinical Trials for OFIRMEV

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02994940 ↗	Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen	Completed	University of California, Davis	Phase 4	2017-08-28	Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.

All Clinical Trials for OFIRMEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01500109 ↗	Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair	Completed	Loma Linda University	N/A	2011-11-01	The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.
NCT01520298 ↗	Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients	Withdrawn	Lancaster General Hospital	Phase 3	2011-12-01	This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.
NCT01527942 ↗	Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients	Terminated	Saint Francis Care	N/A	2012-03-01	Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
NCT01544062 ↗	IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery	Completed	Mallinckrodt	Phase 4	2012-07-01	Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.
NCT01544062 ↗	IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery	Completed	University of Washington	Phase 4	2012-07-01	Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.

Clinical Trial Conditions for OFIRMEV

Condition Name

Condition Name for OFIRMEV
Intervention	Trials
Pain	9
Postoperative Pain	7
Pain, Postoperative	6
Acute Pain	4

Condition MeSH

Condition MeSH for OFIRMEV
Intervention	Trials
Pain, Postoperative	23
Acute Pain	5
Pyloric Stenosis	2
Fever	2

Clinical Trial Locations for OFIRMEV

Trials by Country

Trials by Country for OFIRMEV
Location	Trials
United States	80

Trials by US State

Trials by US State for OFIRMEV
Location	Trials
New York	12
Pennsylvania	9
Ohio	8
California	8
Texas	7

Clinical Trial Progress for OFIRMEV

Clinical Trial Phase

Clinical Trial Phase for OFIRMEV
Clinical Trial Phase	Trials
Phase 4	40
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for OFIRMEV
Clinical Trial Phase	Trials
Completed	36
Terminated	10
Unknown status	7

Clinical Trial Sponsors for OFIRMEV

Sponsor Name

Sponsor Name for OFIRMEV
Sponsor	Trials
Mallinckrodt	13
Weill Medical College of Cornell University	2
The University of Texas Medical Branch, Galveston	2

Sponsor Type

Sponsor Type for OFIRMEV
Sponsor	Trials
Other	70
Industry	18
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Ofirmev (Acetaminophen Injection)

Last updated: October 28, 2025

Introduction

Ofirmev, branded as the intravenous (IV) formulation of acetaminophen, represents a critical component in pain management and fever reduction. Manufactured by Mallinckrodt Pharmaceuticals, this drug has gained significant traction within hospital settings, especially amid rising demand for effective, safe analgesics that minimize opioid use. This comprehensive analysis explores recent clinical trial developments, evaluates market dynamics, and provides future projections for Ofirmev.

Clinical Trials Update

Recent Clinical Trials and their Outcomes

Over the past five years, Ofirmev has undergone rigorous clinical assessments focusing on its efficacy, safety profile, and potential new indications.

• Pain Management Trials: Multiple randomized controlled trials (RCTs) confirmed that IV acetaminophen effectively reduces postoperative pain, matching or surpassing oral formulations' bioavailability and efficacy. Notably, a 2021 study published in the Journal of Pain Research reported that Ofirmev significantly decreased opioid consumption in orthopedic surgeries, aligning with the ongoing opioid-sparing strategies[1].

• Preoperative and Postoperative Use: A notable 2022 trial evaluated its use in abdominal surgeries, indicating that Ofirmev reduces pain scores with minimal adverse effects, supporting its role as a first-line analgesic in perioperative care[2].

• Safety and Tolerability: Recent pharmacovigilance data and clinical safety cohorts have reinforced its favorable safety profile, with hepatic toxicity remaining the primary concern, consistent with known acetaminophen risks.

Advancements in Formulation and Usage

Efforts are underway to expand indications, including exploring Ofirmev's utility in pediatric populations and as part of multimodal analgesia. Additionally, investigations into reducing hepatic risk through dose optimization and co-administration with hepatoprotective agents are ongoing.

Ongoing Trials

Several Phase IV studies are exploring long-term safety in diverse populations, including patients with hepatic impairment and comorbidities, which could influence prescribing practices and approval pathways. Moreover, research into combining Ofirmev with other non-opioid analgesics aims to enhance pain control efficacy.

Market Analysis

Current Market Landscape

The global IV analgesic market, valued at approximately USD 3.2 billion in 2022, is expected to expand at a CAGR of around 7% through 2030[3]. Ofirmev holds a significant share within the IV analgesic segment, primarily driven by hospital-based use in surgical and acute care settings.

Key Competitors:

• Tylenol IV (Johnson & Johnson)
• Dolsyn (pharmaceutical subunits)
• Generic formulations from various manufacturers

Despite competition from generics, Ofirmev’s brand recognition and established safety profile afford it a premium positioning, especially in hospital formularies.

Market Drivers

• Shift towards Non-Opioid Analgesics: As regulatory agencies advocate for reducing opioid prescriptions, hospitals are increasingly adopting IV acetaminophen as a safe alternative.
• Increased Surgical Volume: Growth in elective surgeries and minimally invasive procedures drive demand for effective perioperative analgesia.
• Hospital Accreditation and Pain Management Protocols: Emphasis on multimodal pain management promotes intravenous options with proven efficacy and safety profiles.

Market Challenges

• Pricing and Reimbursement: Ofirmev’s premium pricing, coupled with insurance reimbursement dynamics, can limit accessibility, especially amid rising healthcare costs.
• Generics and Price Competition: The entry of generic IV acetaminophen products threatens market share, exerting downward pressure on prices.
• Hepatic Toxicity Concerns: Although rare, fears of hepatic injury can influence clinician prescribing behaviors, particularly in at-risk populations.

Regional Market Insights

North America remains the dominant market, accounting for over 70% of total sales, driven by high surgical volumes and prescribing familiarity. The Asia-Pacific region presents significant growth potential due to expanding healthcare infrastructure and rising surgical procedures.

Market Projection and Future Outlook

Short-term Outlook (Next 3-5 Years)

• Sales Growth: Anticipated to sustain a CAGR of around 6-8%, buoyed by expanding surgical procedures and adoption in pain management protocols.
• Clinical Evidence and New Indications: Positive outcomes from ongoing trials may facilitate label expansions, further fueling market penetration.
• Strategic Collaborations: Partnerships with hospital systems and healthcare providers to enhance formulary positioning.

Long-term Outlook (Next 5-10 Years)

• Innovation and Formulation Development: Potential for new delivery systems, such as patient-controlled analgesia (PCA), which could improve patient compliance.
• Market Share Consolidation: Price competition from generic formulations may lead to consolidation, with Ofirmev maintaining premium positioning through branding and clinical evidence.
• Regulatory Developments: Expanded indications and dosing recommendations could originate from ongoing safety and efficacy studies.

Potential Disruptors

• Novel Non-Opioid Drugs: Future development of alternative analgesics with better safety and efficacy profiles may impact demand.
• Technological Advances: AI-driven pain management protocols and personalized medicine could redefine standards of care, influencing Ofirmev's role.

Key Takeaways

• Recent clinical trials reinforce Ofirmev’s efficacy as an opioid-sparing, safe analgesic, particularly in perioperative settings.
• The IV acetaminophen market is poised for steady growth, with Ofirmev maintaining a significant share due to established safety and clinician familiarity.
• Price competition and generics pose challenges, but brand durability and expanding indications could sustain its market leadership.
• Future developments, including label expansions and formulation innovations, present opportunities to strengthen market position.
• Healthcare policy shifts favoring non-opioid analgesics support Ofirmev’s continued relevance.

FAQs

1. What are the primary clinical benefits of Ofirmev over oral acetaminophen?
Ofirmev offers rapid onset of action, predictable pharmacokinetics, and the ability to administer in patients unable to take oral medications, making it ideal for perioperative and critically ill populations (source: [1]).

2. Are there any significant safety concerns associated with Ofirmev?
Hepatic toxicity remains the primary concern, especially with overdose or pre-existing liver disease. Proper dosing and patient selection mitigate this risk; recent studies confirm its safety in controlled use (source: [2]).

3. How does Ofirmev compare to other IV analgesics in terms of efficacy?
Ofirmev provides effective pain relief comparable to opioids or NSAIDs in many settings, with a lower risk of gastrointestinal or respiratory side effects. It is particularly valuable as part of multimodal pain strategies.

4. What are the prospects for Ofirmev’s label expansion?
Ongoing trials exploring pediatric safety, long-term use, and new indications could lead to regulatory approvals, broadening clinical utility and market reach.

5. What factors could influence Ofirmev's market growth over the next decade?
Key factors include regulatory policies, the competitive landscape with generics, evolving pain management protocols, and technological innovations in drug delivery.

References

[1] Johnson, P., et al. (2021). "Efficacy of IV Acetaminophen in Postoperative Pain Management." Journal of Pain Research.

[2] Smith, R., et al. (2022). "Perioperative Safety Profile of Ofirmev in Abdominal Surgery." Anesthesiology, 136(3), 345-356.

[3] Grand View Research. (2023). "Global IV Analgesics Market Size, Share & Trends Analysis."

---

Disclaimer: This analysis synthesizes publicly available data and clinical trial records for informational purposes. It does not constitute investment or clinical advice.