Pharmacokinetic Study Confirming the Bioequivalence of a Novel Oral Solution of Levothyroxine (Thyquidity™) to Synthroid® Presented at The 90th Annual Meeting of the American Thyroid Association
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."
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
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, www.thyquidity.com.
WARNING: NOT FOR TREATMENT OF OBESITY OR WEIGHT LOSS
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information including Boxed Warning or visit https://www.thyquidity.com/pdf/Prescribing-Information.pdf.
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 www.verticepharma.com.
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SOURCE Vertice Pharma