Oct 30, 2020   SOURCE: PR NewsWire

Licart(TM) Now Available to Treat Acute Pain Due to Minor Strains, Sprains, and Contusions

PARSIPPANY, N.J., Oct. 30, 2020 /PRNewswire/ -- IBSA Pharma Inc. the makers of Flector, the original diclofenac topical system, announced that it has launched Licart (diclofenac epolamine) topical system 1.3% in the US market for the treatment of acute pain due to minor strains, sprains, and contusions.

Licart is the first and only once-a-day topical nonsteroidal anti-inflammatory drug (NSAID) therapy approved by the FDA. Licart contains diclofenac epolamine, a widely-used NSAID, which is delivered via a patented next-generation patch technology that allows for fast onset and sustained pain relief. Licart has been proven to provide significant pain relief within 1-3 hours after application and continues to relieve pain for 24 hours.¹

Licart is the latest product to be launched by the IBSA Pharma Inc., a fully-owned subsidiary of IBSA Institut Biochimique SA which is headquartered in Lugano, Switzerland. IBSA is a world leader in topical pain therapy.

Licart delivers pain relief for a wide variety of patients and pain sites. Each carton of Licart topical system contains 3 envelopes of 5 topical systems per envelope It is easy to use. Patients simply peel Licart from its package and apply it to where it hurts. Licart sticks to skin for a full 24 hours, is mess free, odorless, and won't stain clothes.²

"Licart represents an evolution in the topical treatment of acute pain. While topical NSAID therapy has been available for decades, this is the first FDA-approved topical system with once-a-day dosing," said Dr. Todd Stitik, President of the NJ Society of Physical Medicine & Rehabilitation (PM&R).

"IBSA has leveraged Flector's technology to develop Licart which features patented next-generation patch technology and is the only FDA approved once-a-day topical treatment of acute pain due to minor strains, sprains, and contusions. It is now available through participating mail order and retail pharmacies," stated Aldo Donati, CEO of IBSA Pharma. Licart has been studied extensively in Europe and the value of its patented next-generation patch technology is demonstrated by several clinical studies that have been published in scientific journals.

IBSA offers several programs to provide patients who need Licart, with cost-effective access to Licart. For eligible patients with commercial insurance, the Licart Copay Savings Card may reduce the cost of Licart to as little as $0 per month of therapy. For patients without insurance, inadequate coverage or high insurance copay, the Licart Direct Program is a network of participating mail order pharmacies offering patients the lowest cash price available for Licart. Additional information can be found at www.Licart.com.

About Acute Pain from Minor Strains, Sprains and Contusions

Acute pain from minor strains, sprains and contusions are common in clinical practice. While exact figures are not available, it is estimated that over 2 million ankle sprains occur annually in the US.³ If not treated appropriately, soft tissue injuries like ankle sprains can lead to chronic complications and significant reductions in patient quality of life.

About IBSA Pharma

IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. The company is a world leader in the topical treatment of acute pain and in the treatment of thyroid disease. With products on five continents and in over 80 countries, IBSA manufactures more than 46 million diclofenac patches, 14 million vials of hormones, 300 million soft gel capsules and 60 million packages of finished products every year. IBSA has a commitment to scientific research and improving the health of patients.

INDICATIONS AND USAGE
LICART 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
    --  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
    --  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
    --  Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant
        women starting at 30 weeks gestation
    --  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 IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, visit www.ibsagroup.com/media
*For Full Prescribing Information, visit www.Licart.com

References

1. Coudreuse J-M, de Vathaire F., Current Med Res Opinion,2010; 26(9): 2221-8
2. Licart (diclofenac epolamine) topical system 1.3% (Package Insert); 2020, IBSA Pharma, Parsippany, NJ
3. Herzog M et al; Journal of Athletic Train, 2019;54(6) 603-610

PM-02-20-0025

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SOURCE IBSA Pharma Inc.