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 90^th 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 AUC_{0-72 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, www.thyquidity.com. 

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 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.

References:

1. Vandse S, Washington K, Baron M. Comparative Bioavailability of a Novel Levothyroxine Oral Solution to Tablets. Poster presented at: The 90^th Annual Virtual Meeting of the American Thyroid Association; Sept 30 – Oct 3, 2021
2. 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.
3. Chiovato L, Magri F, Carle A. Advance Therapeutics 2019; 36:S47–S58.
4. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562
5. 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.
6. THYQUIDITY (levothyroxine sodium) oral solution [package insert]. New Providence, NJ: Vertice Specialty Group; 12/2020

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