New Study Confirms That Novel Liquid Levothyroxine Solution Can be Administered as Early as 15 Minutes Before Breakfast

PARSIPPANY, N.J., May 26, 2021 /PRNewswire/ -- A new study demonstrates the ability of a novel liquid formulation of levothyroxine, TirosintSol® developed and commercialized in the United States by IBSA Pharma Inc., to be administered as early as 15 minutes before breakfast without interfering with absorption and systemic availability. The results of the study are being presented today at the American Association of Clinical Endocrinology (AACE) Annual Meeting. The study is the first of its kind to address the limitation of levothyroxine formulations that must be administered on an empty stomach 30-60 minutes before eating breakfast, a requirement posing a significant challenge to adherence to therapy for many patients.

The study examined the bioavailability of Tirosint-SOL when administered in a dose of 600 mcg to healthy volunteers in intervals of 15 and 30 minutes in advance of consuming a high fat, high calorie breakfast, defined by the FDA as a meal of 800-1000 total Kcal with 50% of calories derived from fat. Dr. Murray Ducharme of the University of Montreal is presenting the new findings at this year's AACE meeting which will be held virtually.

The current FDA approved label for Tirosint-SOL directs administration on an empty stomach 30-60 minutes before eating. While patients should continue to follow these  label instructions, results of the study suggest that dosing either 15 minutes or 30 minutes in advance of eating breakfast produces similar levels of drug exposure, which could be of great value to patients. Based on these findings, IBSA Institut Biochimique SA, the sponsor of the study, anticipates seeking FDA approval for a change in the approved labelling for Tirosint-SOL.

"Levothyroxine is a narrow therapeutic index (NTI) drug that requires no interference from food or beverages for consistent dissolution and absorption", said Dr. Ducharme. "The results of this study demonstrate that the wait time needed before breakfast may be shortened to a period of 15 minutes without significant negative effect with the liquid levothyroxine formulation."

Commenting on the study, Dr. Francesco Celi of Virgina Commonwealth University added that the study results should be of interest to both patients and clinicians: "Lack of patient adherence to levothyroxine dosing recommendations is common and may be a frequent reason for suboptimal levothyroxine performance. The opportunity to provide patients living with hypothyroidism with a medication that is easier to use may facilitate both adherence and therapeutic outcomes."   

The study was sponsored by IBSA Institut Biochimique SA, makers of Tirosint^®-SOL (levothyroxine sodium) oral solution. Tirosint-SOL is the only FDA-approved liquid levothyroxine formulation available in monodose packaging for convenience and dosing precision. It is approved for treating hypothyroidism among patients of all ages and is made with only levothyroxine, glycerol and water for enhanced tolerability and absorption. Tirosint-SOL is currently available in 12 dosage strengths and may be administered by squeezing -the contents of the monodose ampule directly into the mouth, using a spoon or mixing the drug in water. Additional information, including money saving options for patients that may reduce the cost of Tirosint-SOL to as little as $25 per month can be found at www.TirosintSOL.com. The Tirosint Direct Program provides patients with another savings option for obtaining their prescribed therapy. Through the Tirosint Direct program, patients can access a network of mail order pharmacies providing Tirosint-SOL for as little as $40 per month regardless of their insurance coverage. Go to www.TirosintSOL.com for more details.

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. ¹ Up to 13 million Americans have undiagnosed hypothyroidism. ² 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.³ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.⁴ Laboratory tests (TSH, FT3 and FT4) are the most common biochemical parameters used in diagnosing hypothyroidism.⁵ 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 inadequate levels of thyroid stimulating hormone (TSH).

About IBSA Pharma

IBSA Pharma is part of IBSA Group, headquartered in Lugano, Switzerland. It is a world leader in the treatment of thyroid disease and has a diversified product portfolio of prescription drugs. With products on five continents and over 80 countries, IBSA is committed to scientific research and improving the health of patients.

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 www.ibsagroup.com/media. For Full Prescribing Information, visit www.Tirosint.com

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-SOL, should not be used for the treatment of obesity or for
• weight loss.
• Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening
• manifestations of toxicity

CONTRAINDICATIONS

• Hypersensitivity to glycerol
• Uncorrected adrenal insufficiency

WARNINGS AND PRECAUTIONS

• Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation
• Myxedema coma: Do not 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-SOL 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

Limitations of Use

• Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
• Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Adverse Reactions
Common adverse reactions with TIROSINT-SOL 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-01-21-0003 

SOURCE IBSA Pharma, Inc.

Related Links

www.ibsagroup.com

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

440k+
Newsrooms &
Influencers

9k+
Digital Media
Outlets

270k+
Journalists
Opted In

GET STARTED