Acertis Enters Pain Market with Once-A-Day Diclofenac Patch

RALEIGH, NC – January 07, 2026 – Acertis Pharmaceuticals has made a significant move into the U.S. pain management sector, announcing an exclusive agreement with Swiss pharmaceutical giant IBSA to commercialize Licart® (diclofenac epolamine topical system 1.3%). The deal gives the Raleigh-based specialty company the U.S. rights to the first and only FDA-approved once-daily topical nonsteroidal anti-inflammatory drug (NSAID) patch for treating acute pain from minor strains, sprains, and contusions.

This strategic licensing agreement positions Acertis to challenge established players by offering a new level of convenience in a highly competitive market. For patients and physicians navigating the complexities of pain management, the arrival of a once-a-day topical treatment offers a potentially compelling alternative to existing therapies that require more frequent application.

A New Contender in a Crowded Market

The U.S. topical pain relief market is a formidable landscape, valued at over $3 billion and projected to grow significantly in the coming years. It is currently dominated by household names like Voltaren, Salonpas, and Bengay, with major pharmaceutical companies such as GlaxoSmithKline and Hisamitsu Pharmaceutical holding substantial market share. The segment is driven by an aging population, a high incidence of musculoskeletal injuries, and a strong, ongoing shift away from opioid-based pain management.

Within this space, Licart enters as a differentiated product. While other topical diclofenac formulations exist, including gels and multi-dose patches, Licart’s key advantage is its once-daily application. Its most direct competitor in patch form, the Flector Patch, which also contains diclofenac epolamine, requires twice-daily application. This distinction in dosing frequency could be a critical factor for improving patient adherence, a common challenge in managing acute conditions. By simplifying the treatment regimen to a single daily application, Acertis is betting that convenience will be a powerful driver of adoption for both prescribers and patients seeking effective, easy-to-use, non-opioid solutions for acute pain.

The Science of 24-Hour Relief

At the core of Licart's appeal is its patented delivery technology. The patch is designed to provide a fast onset of action, with clinical data suggesting pain relief can begin within one to three hours of application, and then sustain that relief for a full 24 hours. This is achieved through a unique topical system that combines two innovative technologies to enhance the permeability of the skin, allowing the active ingredient, diclofenac, to penetrate deeply and act directly at the site of injury.

Diclofenac is a well-established and widely used NSAID, but delivering it topically offers a significant advantage: it minimizes systemic absorption. Compared to oral NSAIDs, where the drug circulates throughout the body, a topical patch delivers a concentrated dose to the affected area, thereby reducing the potential for systemic side effects. Clinical studies have supported the efficacy of the diclofenac epolamine 1.3% patch. Research has shown significant pain reduction in patients with acute soft tissue injuries compared to a placebo, with some studies noting that the median time to pain resolution was several days shorter for patients using the patch. Furthermore, patient satisfaction has been reported as high, with users citing the ease of application and the duration of pain relief as key benefits.

A Strategic Play for Growth

For Acertis Pharmaceuticals, this licensing deal is more than just adding a new product; it is a cornerstone of its corporate strategy. The company aims to build a portfolio of differentiated products that address unmet needs, and Licart fits this mission perfectly. Richard Pascoe, Chief Executive Officer of Acertis, emphasized the significance of the agreement in a statement.

“We are pleased to license Licart as we continue to execute our strategic plan of building a growth-oriented, specialty pharmaceutical company,” Pascoe said. “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.”

The deal is also noteworthy from the perspective of IBSA. The Swiss multinational has a presence in over 90 countries, including its own U.S. subsidiary. By partnering with Acertis, IBSA is leveraging a specialized commercial partner with a dedicated focus on the U.S. pain management market. This type of strategic partnership allows global innovators to maximize the reach and impact of their products by tapping into the specific expertise and infrastructure of a local player like Acertis.

Balancing Innovation with Safety

Despite the advantages of its topical delivery system, Licart, as an NSAID, carries the same serious safety warnings as others in its class. The product’s packaging and prescribing information include a prominent Boxed Warning—the FDA’s most stringent—regarding the risk of serious cardiovascular and gastrointestinal events. NSAIDs can increase the risk of heart attack, stroke, and fatal gastrointestinal bleeding, ulceration, or perforation. These risks can manifest early in treatment and may increase with prolonged use. The warning explicitly states that Licart is contraindicated for patients undergoing coronary artery bypass graft (CABG) surgery and should not be used on damaged or non-intact skin.

Healthcare providers and patients must carefully weigh these risks against the benefits of pain relief. While topical application results in substantially lower systemic drug concentration compared to oral pills—potentially mitigating some risk—the warning underscores that the potential for serious adverse events is not eliminated. Responsible commercialization requires robust education for both clinicians and the public about the proper use of the product and its associated risks.

Recognizing this, Acertis has announced plans for comprehensive patient support initiatives. The company will offer a copay savings program, which may allow commercially insured patients to pay as little as $15 per prescription. Additionally, a direct-to-patient pharmacy service, the Licart Direct Program, will offer the lowest available cash price for those without insurance coverage. These programs are designed not only to improve affordability and access but also to provide a channel for distributing educational resources to ensure patients are well-informed about their treatment.