Vertice Launches Thyquidity (levothyroxine sodium) Oral Solution
NEW PROVIDENCE, N.J., Feb. 24, 2021 /PRNewswire/ -- Vertice Pharma ("Vertice"), a specialty pharmaceuticals company focused on improving patients' health, today announced the launch of Thyquidity. Thyquidity is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.*
Thyquidity is a liquid dosage form of levothyroxine administered by a calibrated oral syringe, and is designed to deliver individualized dosing for patients. Thyquidity is a liquid oral solution of levothyroxine sodium containing 100 mcg per 5 mL (20 mcg per mL), and it is supplied in a package of two 100 mL bottles. Thyquidity offers broad dosing flexibility for patients, as well as consistent daily dosing.
"The launch of Thyquidity marks our first branded pharmaceutical prescription product and reflects our ongoing mission to deliver high-quality and affordable pharmaceutical products for patients. Vertice is committed to providing branded and specialty generics products and we look forward to building off the momentum of today's launch," said Scott Meyers, Chief Executive Officer of Vertice Pharma.
Vertice's co-promotion partner is MannKind Corporation (Nasdaq: MNKD). MannKind's sales force will promote Thyquidity to adult and pediatric endocrinologists and other U.S. healthcare providers who treat hypothyroidism.
"Thyquidity fits nicely into our product portfolio of branded and specialty generics and is an exciting launch for the team at Vertice. As we continue to evaluate select opportunities to bring products to market, we are proud to have partnered with MannKind in the launch of this important product," said John Walsh, Head of Specialty Sales and Marketing at Vertice Pharma.
Hypothyroidism, also called underactive thyroid disease, is a common disorder in which the thyroid gland does not produce enough thyroid hormone to meet the needs of the body. The prevalence of hypothyroidism is 4.6% in the US population.1 Symptoms include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin.2 Most patients require lifelong therapy to treat their hypothyroidism.3
Vertice Pharma was founded in 2015 with a unique focus on acquiring specialty pharmaceutical companies and products, including both branded and generic products, to create a durable specialty pharmaceutical business of scale.
Patient Use and Important Safety Information
USE
ThyquidityTM (levothyroxine sodium) oral solution is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. Thyquidity should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).
IMPORTANT SAFETY INFORMATION
- Thyroid hormones, including Thyquidity, either alone or in combination with other drugs, should not be used for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of Thyquidity used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.
- Do not use Thyquidity if you have uncorrected adrenal problems.
- Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking Thyquidity. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.
- Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.
- Once your doctor has found your specific Thyquidity dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.
- Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less Thyquidity from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of Thyquidity may need to be adjusted.
- Use Thyquidity only as ordered by your doctor. Take Thyquidity as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
- Products such as iron and calcium supplements and antacids can lower your body's ability to absorb levothyroxine, so Thyquidity should be taken 4 hours before or after taking these products.
- Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking Thyquidity. Your dose of Thyquidity may need to be increased during your pregnancy.
- Monitor your baby from birth to 3 months of age for vomiting and/or diarrhea as Thyquidity can cause gastrointestinal irritation due to the glycerol component.
- It may take several weeks before you notice an improvement in your symptoms.
- Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.
- Tell your doctor or dentist that you are taking Thyquidity before any surgery.
- Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.
- Partial hair loss may occur during the first few months you are taking Thyquidity.
This is the most important safety information you should know about Thyquidity. For more information, talk with your doctor.
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:
http://www.Thyquidity.com/pdf/Prescribing-Information.pdf for full US Prescribing Information including Boxed Warning.
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
- Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182. PMID: 11836274.
- Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562. https://pubmed.ncbi.nlm.nih.gov/28336049/
- 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. https://www.ncbi.nlm.nih.gov/pubmed/25266247.
* Please see http://www.Thyquidity.com/pdf/Prescribing-Information.pdf for full US Prescribing Information including Boxed Warning.
SOURCE Vertice Pharma
Posted: February 2021
Thyquidity (levothyroxine sodium) FDA Approval History
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