Oral Solution Available for Treating Hypothyroidism

IBSA Pharma’s levothyroxine sodium (Tirosint-SOL) oral solution is now available in the United States market for the treatment of hypothyroidism and pituitary thyrotropin suppression.

Levothyroxine sodium is the first and only liquid levothyroxine formulation approved by the FDA and is indicated for patients of all ages, according to IBSA Pharma. Levothyroxine is 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).

The unique liquid formulation of IBSA Pharma’s levothyroxine sodium oral solution is made without excipients, such as dyes, wheat starch, lactose, alcohol, sugar and others that may contribute to tolerability and absorption issues. It is packaged in monodose ampules in 12 different dosage strengths, including a 13 mcg/mL dose. This product may be administered either directly into the mouth or diluted in a glass of water.

IBSA Pharma’s levothyroxine sodium oral solution will be available through mail orders and in retail pharmacies March 1, according to Aldo Donati, CEO of IBSA Pharma. This product has been studied extensively in Europe and the value of its unique formulation demonstrated by several clinical studies have been published in scientific journals

"Tirosint-SOL represents an evolution in hypothyroidism treatment. While levothyroxine therapy has been available for decades, this is the first FDA-approved liquid levothyroxine formulation," said Dr Murray Ducharme, Professeur Associé, Faculté de Pharmacie at the University of Montreal, in a prepared statement. "This easy-to-swallow option will provide a useful new option for many patients who may benefit from a liquid rather than an oral solid version of this proven therapy."

IBSA offers several programs to provide patients who need levothyroxine sodium, with cost-effective access to this oral solution, including a copay savings card.

Adverse effects associated with IBSA Pharma’s levothyroxine sodium oral solution are primarily those of hyperthyroidism due to therapeutic overdosage. These effects include 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.

Reference

Tirosint®-SOL Now Available to Treat Hypothyroidism in the U.S. [news release]. Parsippany, New Jersey; February 27, 2019: IBSA Pharma. https://prnmedia.prnewswire.com/news-releases/tirosint-sol-now-available-to-treat-hypothyroidism-in-the-us-300803159.html. Accessed February 27, 2019.