Prescription-strength combination of acetaminophen and ibuprofen offers non-opioid treatment option and easier access for patients with mild-to-moderate acute pain

AUCKLAND, New Zealand, Sept. 8, 2026 /PRNewswire/ — Today, AFT Pharmaceuticals announced the U.S. launch of Combogesic^®, a new FDA Approved, Non-Opioid, prescription-strength combination of acetaminophen and ibuprofen developed for adult patients (over age 18) for the short-term management of mild-to-moderate acute pain. This adds the US to 66 countries around the world where this product is now available.

In partnership with the Mark Cuban Cost Plus Marketplace, Combogesic brings together two of the world’s most well-known pain relievers. Combogesic offers a clinically proven, FDA approved combination, providing healthcare professionals with another non-opioid treatment option for appropriate patients. For one of healthcare’s most common experiences, pain management can still involve unnecessary complexity.

Utilizing AFT Pharmaceuticals’ Qiksolv^® formulation technology, Combogesic combines prescription-strength acetaminophen and ibuprofen into a single tablet. Rather than requiring patients to coordinate multiple medicines and dosing schedules, Combogesic delivers both analgesics in one treatment. Clinical studies have demonstrated the effectiveness of Combogesic in the short-term management of mild-to-moderate acute pain.

“Expectations for pain management have evolved, yet the options to treat have remained limited,” said Hartley Atkinson, founder and managing director of AFT Pharmaceuticals. “Rather than inventing another molecule, we asked whether we could rethink how two of the world’s most well-known pain medicines could work together in a single prescription-strength product. The result is a proven formulation that gives healthcare professionals another non-opioid treatment option for appropriate patients.”

That philosophy extends beyond the medicine itself. Through their partnership with the Mark Cuban Cost Plus Marketplace”, AFT Pharmaceuticals is pairing pharmaceutical innovation with a world class pharmaceutical distribution model intended to improve patient health and making Combogesic accessible and affordable to patients across the United States.

“We should all get excited to have more prescription, non-opioid options to combat pain” said Mark Cuban, founder of Mark Cuban Cost Plus Drug Company. “We started Mark Cuban Cost Plus Marketplace because every American should have access to safe, affordable medicines as an essential part of advancing healthcare. So ultimately patients benefit when new medications are paired with access and price transparency. That’s exactly what this partnership is about. We’re proud to help make Combogesic available to patients across the country.”

As pain management continues to evolve, healthcare professionals and patients are looking for treatment options that reflect the realities of modern care. Combogesic reflects AFT Pharmaceuticals’ commitment to expanding non-opioid treatment options for appropriate patients.

For more information, visit Combogesic.com.

IMPORTANT SAFETY INFORMATION

See full prescribing information for complete boxed warning.

About AFT Pharmaceuticals

AFT is a growing New Zealand-based multinational pharmaceutical company that develops, markets, and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories, which are distributed across all major pharmaceutical distribution channels: over the counter (OTC), prescription and hospital. Our product portfolio comprises both proprietary and in-licensed products, and includes patented, branded, and generic drugs. Our business model is to develop and in-license products for our markets of Australia, New Zealand, Singapore, Malaysia, Hong Kong, USA, Canada, EU ex Ireland and UK, and to out-license our products to licensees and distributors in over 125 countries around the world. For more information about the company, visit our website www.aftpharm.com 

About Mark Cuban Cost Plus Drugs

The Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) aims to fundamentally change the way the pharmaceutical industry operates. As a public-benefit corporation, its social mission of improving public health is just as important as the bottom line. Cost Plus Drugs transparently charges a standard markup on every drug it sells. The costplusdrugs.com online pharmacy launched in January 2022 now carries over 2,300 prescription products, delivered by mail to thousands of happy customers every day. Customers can also go to participating retail pharmacies to receive Cost Plus Drugs pricing through the Team Cuban Card. Cost Plus Drugs is working with health plans, managed-care organizations, PBMs, and self-insured employers to bring these same savings to benefit plans nationwide. Learn more at www.markcubancostplusdrugcompany.com.

IMPORTANT SAFETY INFORMATION Continued…

Contraindications

• patients with known hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product
• patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
• Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
• the setting of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

• Hepatotoxicity. COMBOGESIC® contains acetaminophen and ibuprofen.  Acetaminophen has been associated with cases of acute liver failure; the risk is higher in those with underlying liver disease and in those who ingest alcohol. Use in patients with hepatic impairment is not recommended. Elevations of ALT or AST have been reported in NSAID-treated patients.
• Cardiovascular Thrombotic Events. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
• Gastrointestinal Bleeding, Ulceration, and Perforation. NSAIDs may cause serious and sometimes fatal GI adverse events at any time and without warning. Avoid use in patients at higher risk. In concomitant use with low-dose aspirin, monitor patients more closely for evidence of GI bleeding.
• Hypertension. NSAIDs can lead to onset of new hypertension or worsening of pre-existing hypertension, which may contribute to the increased incidence of CV events.
• Heart Failure and Edema. Avoid use in patients with severe heart failure unless benefits outweigh risk.
• Renal Toxicity and Hyperkalemia. Use in patients with renal impairment is not recommended.  Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Increases in serum potassium concentration, including hyperkalemia, have been reported.
• Hypersensitivity and Anaphylactic Reactions. Hypersensitivity and anaphylaxis associated with ibuprofen and acetaminophen have been reported, including life-threatening anaphylaxis associated with acetaminophen.
• Exacerbation of Asthma Related to Aspirin Sensitivity. Patients with asthma may have intolerance to aspirin and other NSAIDs.
• Serious Skin Reactions. Acetaminophen or NSAIDs may cause serious skin reactions such as exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or fixed drug eruption (FDE), generalized bullous fixed drug eruption (GBFDE), which can be fatal and may occur without warning.  Discontinue the use of COMBOGESIC® at the first appearance of skin rash or any other sign of hypersensitivity.
• Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). DRESS that may be life-threatening or fatal has been reported in patients taking NSAIDs.
• Fetal Toxicity: Premature Closure of Fetal Ductus Arteriosus. Avoid use of COMBOGESIC® in pregnant women at about 30 weeks gestation and later. COMBOGESIC® increases the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
• Oligohydramnios/Neonatal Renal Impairment. Use of COMBOGESIC® at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Hematologic Toxicity. Anemia has occurred in NSAID-treated patients and NSAID-treatment may increase the risk of bleeding events.
• Ophthalmological Effects. Blurred or diminished vision, scotomata, and/or changes in color vision have been reported with oral ibuprofen.
• Aseptic Meningitis. Aseptic meningitis with fever and coma has been observed in patients on oral ibuprofen.
• Masking of Inflammation and Fever. Activity of COMBOGESIC® in reducing inflammation, and possibly fever, may diminish signs of infections.
• Laboratory Monitoring. Monitor patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.

Adverse Reactions

The most common adverse reactions (> 2%) are nausea, vomiting, headache, dizziness, somnolence, post-procedural hemorrhage, and swelling of the face.

Drug Interactions

• Drugs That Interfere with Hemostasis. Ibuprofen and anticoagulants have a synergistic effect on bleeding. Concomitant use increases the risk of serious bleeding. Concomitant use of drugs that interfere with serotonin reuptake and an NSAID may increase the risk of bleeding.
• ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers. NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or Beta-Blockers.  In the elderly, volume depleted, or those that have renal impairment, concomitant use with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.
• Diuretics. NSAIDs can reduce the natriuretic effect of loop diuretics and thiazides in some patients.
• Digoxin. Concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
• Lithium. NSAIDs produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
• Methotrexate. Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity.
• Cyclosporine.  Concomitant use of NSAIDs and cyclosporine may increase cyclosporine’s nephrotoxicity.
• NSAIDS and Salicylates.  Concomitant use with other NSAIDs or salicylates increases the risk of GI toxicity.
• Pemetrexed.  Concomitant use of NSAIDs and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Indications and Usage

COMBOGESIC® is indicated in adults (over age 18) for the short-term management of mild to moderate acute pain.

To report an adverse event or product complaint, please contact us at customer.service@aftpharm.com or call 01-248-631-4810. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.

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SOURCE AFT Pharmaceuticals