Diclofenac

Clinical study update UPPSALA, Sweden, Jan. 9, 2026 /PRNewswire/ -- Synartro is advancing the candidate drug SYN321, a novel intra-articular treatment for knee osteoarthritis, through a phase 1/2a clinical study focused on safety, tolerability, PK, and early efficacy signals. The study was initiated in August 2025 following approval from the Swedish Medical Products Agency (MPA) and the Swedish Ethical Review Authority. The study has enrolled a total of 35 participants with knee osteoarthritis. All four cohorts were recruited and treated within a four-month period: Cohort 1 (n=7), Cohort 2 (n=8), Cohort 3 (n=8), and Cohort 4 (n=12). Following review by the internal safety review committee (iSRC), the highest dose tested in Cohort 3 was approved for expansion in Cohort 4. Cohorts 1-3 have completed the study in accordance with the protocol. Cohort 4 is ongoing, with follow-up assessments conducted at weeks 4 and 6. Last Patient Last Visit (LPLV) is scheduled for the first week of February 2026. Unblinding of the study is planned for the second week of March 2026, after which analyses of safety, tolerability, and pharmacokinetic (PK) data will be performed. Interim safety and pharmacokinetic observations Interim data generated to date are consistent with preclinical observations. No serious adverse events related to the investigational medicinal product (IMP) have been reported. Observed adverse events are consistent with those commonly associated with intra-articular injections. No allergic reactions or immunological safety signals have been observed to date. These observations are based on data available to date, and the study is ongoing. Mean Cmax values in plasma from Cohorts 1 and 2 indicate very low systemic exposure to diclofenac. Cmax data from Cohorts 3 and 4 are pending. Plasma concentrations of diclofenac-derived by-products have been below the limit of quantification, supporting the intended slow-release characteristics of SYN321. CONTACT: For further information, please contact: Magnus Hurst, CFO & acting CEO. Tel: +46 (0) 760 27 44 27. E-mail: [email protected] This information was brought to you by Cision 21% more press release views with Request a Demo

RALEIGH, N.C.--(BUSINESS WIRE)--Acertis Pharmaceuticals, a specialty pharmaceutical company focused on delivering differentiated therapies to patients, today announced that it has entered into an exclusive agreement with Swiss pharmaceutical company IBSA Institut Biochimique SA to license the U.S. commercial rights for Licart® (diclofenac epolamine topical system 1.3%), the first and only FDA-approved once-daily topical nonsteroidal anti-inflammatory drug (NSAID) patch for the treatment of acute pain due to minor strains, sprains, and contusions. Licart utilizes patented next-generation patch technology to deliver diclofenac epolamine offering patients a fast onset of action within 1–3 hours and sustained pain relief for up to 24 hours. This innovative design provides convenience with once-a-day dosing, for patients managing acute pain due to minor strains, sprains, and contusions. Strengthening Acertis’ Pain Management Portfolio By licensing Licart, Acertis strengthens its growing portfolio of specialty products in pain management and related therapeutic areas. “We are pleased to license Licart as we continue to execute our strategic plan of building a growth-oriented, specialty pharmaceutical company,” said Richard Pascoe, Chief Executive Officer, Acertis Pharmaceuticals. “Licart’s once-daily dosing and advanced delivery system represent a meaningful improvement in topical NSAID therapy, aligning with Acertis’ mission to provide innovative, patient-centric treatment options.” Continued Patient Support Programs Acertis will support Licart with robust patient assistance initiatives, including copay savings programs, direct-to-patient pharmacy services, and educational resources for healthcare providers. Most commercially insured patients may be eligible to pay as little as $15 per prescription through the Licart Copay Card, while the Licart Direct Program offers the lowest available cash price for patients regardless of insurance coverage. About Licart® Licart (diclofenac epolamine topical system 1.3%) is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. As the only FDA-approved once-daily topical NSAID patch, Licart delivers a widely used and well-established NSAID in a unique topical system that combines two innovative drug delivery technologies for enhanced permeability and sustained pain relief. Additional information is available at www.Licart.com. About Acertis Pharmaceuticals Acertis Pharmaceuticals is a specialty pharmaceutical company dedicated to building a differentiated portfolio of products that address unmet needs in pain management and other therapeutic categories. With a focus on licensing, commercialization, and patient-first solutions, Acertis partners with global innovators to bring meaningful therapies to U.S. patients. The company is headquartered in Raleigh, North Carolina. About IBSA IBSA (Institut Biochimique SA) is a Swiss pharmaceutical multinational with 20 subsidiaries across Europe, China, and the United States. Its products are available in over 90 countries, and its R&D activities focus on 10 therapeutic areas. In 2025, IBSA celebrates the 40th anniversary of its acquisition by current President and CEO, Arturo Licenziati, who has transformed the company into a multinational corporation employing over 2,300 personnel worldwide. IBSA’s growth and development can be attributed to its ability to innovate by refining well-known molecules, as well as to its commitment to looking to the future responsibly and transparently, thanks to the dedication and dynamism of its people. Use & Important Safety Information INDICATIONS AND USAGE LICART contains diclofenac epolamine, which is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. LICART is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. CONTRAINDICATIONS LICART is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. 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. In the setting of coronary artery bypass graft (CABG) surgery. On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds. WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. Heart Failure and Edema : Avoid use of LICART in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of LICART in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. Exacerbation of Asthma Related to Aspirin Sensitivity : LICART is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). Serious Skin Reactions : Discontinue LICART at first appearance of skin rash or other signs of hypersensitivity. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue and evaluate clinically. Fetal Toxicity : Limit use of NSAIDs, including LICART, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. ADVERSE REACTIONS Most common adverse reactions for LICART are application site pruritus and other application site reactions. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch References: 1. Licart (diclofenac epolamine) topical system 1.3% [package insert]. Parsippany, NJ: IBSA Pharma; 2020. 2. Coudreuse J-M, et al. Curr Med Res Opin. 2010;26(9):2221-2228. Please visit Licart.com for Full Prescribing Information, including Boxed Warning Once-a-day Patch, All-day Relief PR ACRX- 92225