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Tirosint® now available in 15 dosage strengths PARSIPPANY, N.J., April 4, 2023 /PRNewswire/ -- Americans diagnosed with hypothyroidism now have access to greater dosage flexibility for levothyroxine therapy. IBSA Pharma Inc. is introducing three new dosage strengths of Tirosint® (levothyroxine sodium) capsules to treat hypothyroidism.[1] The three new dosing options – 37.5, 44 and 62.5 micrograms – add to Tirosint's existing 12 options and, along with similar doses of Tirosint®-SOL (levothyroxine sodium) oral solution, provide the widest range of doses for any levothyroxine drug approved by the U.S. Food and Drug Administration (FDA). Recently published research has demonstrated that dissatisfaction is common among adults treated for hypothyroidism.[2] While the causes of patient dissatisfaction are complex, the common practice of frequent dose titration of thyroid hormone treatment (more than two dose changes per year) has been associated with significantly lower levels of patient satisfaction with hypothyroidism therapy.[3] Tirosint's extensive dosing options provide clinicians with more choices, enabling them to adapt levothyroxine therapy to individual needs to better treat the full spectrum of hypothyroid patients. Increased dosage flexibility may also eliminate or reduce the need to change patients' doses. "The addition of 37.5, 44 and 62.5 microgram dosages, along with the brand's unique 13 mcg dose, provides physicians and patients with much-needed flexibility in levothyroxine therapy, the standard of care for treating hypothyroidism," said Carolyn Kong, PharmD, Chief Medical and Business Officer of IBSA Pharma Inc. "Up to this time, clinicians who wanted to prescribe oral solid formulations of levothyroxine in these doses needed to instruct caregivers and patients to split levothyroxine tablets or combine different dosage strengths. This can result in both inconvenience and significant dosing errors. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses. These new doses of Tirosint will now match those of Tirosint-SOL, providing a convenient and safe way to provide these doses of levothyroxine to patients who need them." Tirosint is the leading FDA-approved levothyroxine gel capsule available in the US. It has been clinically proven to effectively treat the full spectrum of hypothyroid patients from those with general hypothyroidism to those who have concomitant conditions that can complicate therapy. With only four ingredients – levothyroxine, glycerin, gelatin, and water – Tirosint does not contain inactive ingredients or preservatives that are commonly found in traditional levothyroxine tablet therapies that can interfere with medication tolerability or absorption. Tirosint is indicated to treat hypothyroidism in patients 6 years of age and older and for pituitary thyrotropin (Thyroid Stimulating Hormone – TSH) suppression as an adjunct to surgery and radioactive iodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Tirosint is widely available in retail pharmacies. To help provide patients with cost-effective access to Tirosint, IBSA provides copay coupons and other cost saving programs. With the Tirosint Copay Savings Coupon, eligible patients with commercial insurance may pay as little as $25 per one-month supply of Tirosint or $50 per three-month supply. Patients with high deductibles/copays, without commercial insurance or paying cash can access the Tirosint Direct Program to get the lowest cash price for Tirosint. Additional information can be found at Tirosint.com. About Hypothyroidism Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. More than 27 million adults have been diagnosed with hypothyroidism.[4] Large observational studies and meta-analyses have shown that about 4–7% of community-derived populations in the USA and Europe have undiagnosed hypothyroidism.[5] About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism. The condition is most common in women over 40 years of age and in the elderly of both sexes.[6] The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.[7] TSH laboratory tests are recommended as first-line screening tests for thyroid dysfunction.[8] Levothyroxine sodium is a synthetic version of a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or require supression of thyroid stimulating hormone (TSH). About IBSA Pharma Inc. IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. It currently markets 4 prescription medications in the United States including Tirosint capsules. These include Tirosint-SOL (levothyroxine sodium) oral solution which is indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and for pituitary thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer; Licart (diclofenac epolamine) topical system 1.3% and Flector (diclofenac epolamine) topical system 1.3% which are indicated for the treatment of acute pain from minor strains, sprains, and contusions. IBSA Institut Biochimique SA IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company's 17 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 800 million CHF, and employs over 2,000 people between headquarters, subsidiaries, and production sites. IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health. It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world's leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility. To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800- FDA-1088 For more information about IBSA, visit . For full prescribing information, visit . References IMPORTANT SAFETY INFORMATION Warning: Not for the Treatment of Obesity or for Weight Loss See full prescribing information for complete boxed warning Thyroid hormones, including TIROSINT, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious often life threatening manifestations of toxicity. Contraindications Uncorrected adrenal insufficiency Warnings And Precautions Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease. Initiate TIROSINT at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation Myxedema coma: Do no use oral thyroid hormone drug products to treat myxedema coma Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT treatment Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose Adverse Reactions Adverse reactions associated with Tirosint are primarily those of hyperthyroidism due to therapeutic overdosage including: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash. PM-00-23-0031 SOURCE IBSA Pharma, Inc.

BERKELEY HEIGHTS, N.J., Oct. 1, 2021 /PRNewswire/ -- Vertice Pharma announces the results of a recent study demonstrating the bioequivalence of Thyquidity™, an oral liquid solution of levothyroxine sodium to Synthroid®. The study results were presented on September 30, 2021 during a virtual poster session at the 90th annual meeting of the American Thyroid Association. The study compared Thyquidity™ oral solution to Synthroid® tablets in a single dose (600 mcg) crossover comparative bioavailability pharmacokinetic trial (N=42) in healthy adult subjects under fasting conditions.1 The results revealed that the geometric LS mean ratio of AUC0-72 and Cmax for baseline-adjusted levothyroxine were 109.1% (100.6-118.2%) and 107.9% (101.7-114.6%) for Thyquidity and the reference, Synthroid tablet respectively.1 The corresponding 90% Confidence Intervals (CIs) were within the US Food and Drug Administration (FDA) acceptance range of 80% to 125%, establishing bioequivalence. The incidence of adverse events (AEs) was similar between treatment groups.1 There were no serious adverse events or discontinuations due to AEs.1 Novel oral formulations of levothyroxine that do not require a dissolution phase in the stomach represent the most recent treatment options for patients with hypothyroidism.2 "Thyquidity's liquid formulation expands dosing options for patients with varying treatment needs," said Noel Greenberger, Chief Commercial Officer of Vertice Pharma. "Thyquidity is a FDA-approved treatment option for patients living with hypothyroidism. We are pleased to have the opportunity to share the bioequivalence data comparing Thyquidity with Synthroid tablets." About Hypothyroidism Hypothyroidism is one of the most common diseases worldwide.3 It affects up to 5% of the general population, with a further estimated 5% being undiagnosed. 3 Hypothyroidism occurs when the thyroid gland, located in the neck does not produce enough thyroid hormone for the body's requirements.3 The condition occurs more frequently in women, in older people (>65 years), and in white individuals, although data on ethnic differences are scarce.4 Hypothyroidism can include a wide variety of symptoms that differ with age, sex, and time between onset and diagnosis.4 Oral levothyroxine is considered first-line treatment, with most patients requiring lifelong therapy.5 About Thyquidity Thyquidity is an oral solution containing 100mcg/5 mL of levothyroxine sodium.6 It is approved by the FDA for the following indications: (1) as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and (2) as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.6 Thyquidity is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with Thyquidity may induce hyperthyroidism. Thyquidity is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Thyquidity is the first levothyroxine oral solution that allows individualized dosing flexibility not limited by fixed dosage strengths. The formulation allows administration of the full range of clinically acceptable dosing options for diverse clinical scenarios, including the elderly, pregnant women, and pediatric patients. Additional information, including patient and healthcare provider resources may be found at, . Important Safety Information WARNING: NOT FOR TREATMENT OF OBESITY OR WEIGHT LOSS Thyroid hormones, including THYQUIDITY, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. THYQUIDITY is contraindicated in patients with uncorrected adrenal insufficiency. In the elderly and in patients with cardiovascular disease, THYQUIDITY should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease. If cardiac symptoms develop or worsen, the THYQUIDITY dose should be reduced or withheld for one week and restarted at a lower dose. Patients with coronary artery disease who are receiving THYQUIDITY should be monitored closely during surgical procedures for cardiac arrhythmias. Monitor patients during concomitant administration of THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency. Use of oral thyroid hormone is not recommended in myxedema coma. Products formulated for IV administration should be used to treat myxedema coma. Patients with adrenal insufficiency should be treated with replacement glucocorticoids prior to initiating treatment with THYQUIDITY. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated. THYQUIDITY has a narrow therapeutic index. Regardless of the indication for use, careful dosage titration is necessary to avoid the consequences of over- or under-treatment. Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing THYQUIDITY. Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, patients receiving THYQUIDITY should be given the minimum dose necessary that achieves the desired response. Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage. Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to THYQUIDITY. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with THYQUIDITY. Closely monitor patients from birth to 3 months of age receiving THYQUIDITY due to the potential for glycerol- induced gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea. THYQUIDITY should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and THYQUIDITY dose adjusted as needed. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information including Boxed Warning or visit . About Vertice Pharma Vertice Pharma is a specialty pharmaceutical company focused on improving patients' health. Vertice Pharma develops, manufactures, markets, and distributes high-quality and affordable pharmaceutical products through its operating companies. Vertice Pharma has global headquarters in the United Kingdom and United States headquarters in New Jersey. For more information visit . References: Vandse S, Washington K, Baron M. Comparative Bioavailability of a Novel Levothyroxine Oral Solution to Tablets. Poster presented at: The 90th Annual Virtual Meeting of the American Thyroid Association; Sept 30 – Oct 3, 2021 Fallahi P, Ferrari SM, Elia G, Ragusa F, Paparo SR, Antonelli A. L-T4 therapy in enteric malabsorptive disorders. Front Endocrinol (Lausanne). 2021;12:626371. Chiovato L, Magri F, Carle A. Advance Therapeutics 2019; 36:S47–S58. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562 Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. THYQUIDITY (levothyroxine sodium) oral solution [package insert]. New Providence, NJ: Vertice Specialty Group; 12/2020 Company Contact Vertice Pharma Sophia Massey Sophia.Massey@verticepharma.com 727-530-1633 x276