Akrimax Announces Publication of CONTROL Surveillance Project Results

First in three-part research program

Jan 07, 2016, 10:40 ET from Akrimax Pharmaceuticals

CRANFORD, N.J., Jan. 7, 2016 /PRNewswire/ -- Akrimax Pharmaceuticals announces publication of the results of the CONTROL Surveillance Project in the December 21st edition of Drugs in R&D. The CONTROL Surveillance Project is one of the most comprehensive patient-based surveys ever conducted among patients undergoing levothyroxine treatment. Levothyroxine is the most commonly used drug to treat hypothyroidism and is one of the most widely dispensed drugs in the United States.

The CONTROL Surveillance Project was an online survey conducted among 1,000 adults diagnosed with hypothyroidism, 925 of whom (92.5%) were being treated with levothyroxine monotherapy. Patients were asked to self-report conditions of the gastrointestinal (GI) tract, medications used to treat GI conditions and food allergies. These have been widely reported in the clinical literature as factors that can adversely affect the performance of levothyroxine.

Among participants in the CONTROL Surveillance Project, 47% (435/925) reported suffering from GI conditions including gastroesophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS), lactose intolerance and celiac disease. More than 37% of survey respondents (343/925) reported taking drugs to treat these conditions. Patients taking these drugs were more likely to report frequent changes to their levothyroxine therapy vs. patients not taking these medications (9% vs. 7.4%; p>0.05). Overall, 15.2% of respondents (141/925) reported allergies to foods/ingredients commonly found in tablet formulations of levothyroxine such as food dyes, wheat starch and lactose.

"Levothyroxine has been the gold standard for treating hypothyroidism for over 60 years. In spite of its widespread use, there are few surveys that document the prevalence of commonly-cited reasons for its frequent suboptimal performance," stated Marjorie McMillan, MPH, the study's primary investigator. "GI comorbidities and their treatments, food allergies and other patient factors that affect the absorption and tolerability of levothyroxine are common in clinical practice but are often under recognized by clinicians. This can lead to poor control of hypothyroid symptoms as well as patient and clinician frustration with therapy."

The CONTROL Surveillance Project is part of a three-part program that also includes CONTROL HE (Health Economics) and The CONTROL Registry. The objective of this scientific program is to document the issues and costs related to the use of levothyroxine therapy in real-world clinical settings. "The CONTROL Program will help better define important issues such as malabsorption, tolerability and other factors that are commonly observed with tablet formulations of levothyroxine," stated Keith Rotenberg, Ph.D. Corporate VP and Chief Science Officer at Akrimax. "These can have profound effects on patient outcomes."

The protocol for CONTROL Surveillance Project was reviewed and approved by a licensed Institutional Review Board (IRB) in accordance with US federal guidelines. Sub analyses from the CONTROL Surveillance Project were presented at the 2015 International Thyroid Congress and published in the October 2015 online edition of Thyroid, the journal of the American Thyroid Association. They can be found at http://online.liebertpub.com/thy

About Akrimax Pharmaceuticals

Since 2011 Akrimax and IBSA have worked in collaboration to market Tirosint® (levothyroxine sodium) capsules a unique treatment for hypothyroidism. Tirosint is formulated with just four ingredients: levothyroxine, gelatin, glycerin and water. Clinical studies suggest that Tirosint may be an effective alternative for patients who suffer from tolerability or absorption problems that may be experienced with traditional levothyroxine tablet formulations.

For Full Prescribing Information including Black Box Warning go to www.Tirosint.com

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 a thyroid disorder making it the leading endocrine disorder in the United States.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 way hypothyroidism is detected. Treatment with levothyroxine sodium oral tablets is the standard of care in hypothyroidism.

About Tirosint® (levothyroxine sodium) capsules

Tirosint (levothyroxine sodium) is the first and only levothyroxine therapy in a liquid gel cap.  Tirosint gel caps contain only T4, water, glycerin, and gelatin.

Tirosint is available in 10 dosage strengths, including an exclusive 13 microgram dose. Tirosint is administered as a single daily dose, preferably one-half to one-hour before breakfast. Tirosint should be taken at least 4 hours apart from drugs that are known to interfere with its absorption. Tirosint capsules cannot be cut or crushed. Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.

Tirosint capsules are housed in blister packs to protect it from light and moisture. Blister packs are clearly marked for daily dosing. Tirosint should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

INDICATION
Levothyroxine sodium is L-thyroxine (T4) and is indicated for: Hypothyroidism- As a replacement for supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis; Pituitary Thyrotropin-Stimulating Hormone (TSH) Suppression-As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid cancer.

WARNING: NOT FOR THE TREATMENT OF OBESITY OR WEIGHT LOSS

 

  • Thyroid hormones, including TIROSINT, 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.

Tirosint is indicated as a replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.

Specific indications for Tirosint include: primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or form the effects of surgery, radiation, or drugs, with or without the presence of goiter.

CONTRAINDICATIONS
Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids.

TIROSINT is contraindicated in patients with hypersensitivity to any of the inactive ingredients in TIROSINT capsules.

TIROSINT is contraindicated for anyone who may be unable to swallow a capsule (e.g., infants, small children – generally under 6 years of age) because of the risk of aspiration.

In patients with nontoxic diffuse goiter or nodular thyroid disease, particularly the elderly or those with underlying cardiovascular disease, levothyroxine sodium therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis. If the serum TSH level is not suppressed, TIROSINT should be used with caution in conjunction with careful monitoring of thyroid function for evidence of hyperthyroidism and clinical monitoring for potential associated adverse cardiovascular signs and symptoms of hyperthyroidism

WARNINGS AND PRECAUTIONS
Effects on bone mineral density – In women, long-term levothyroxine sodium therapy has been associated with increased bone resorption, thereby decreasing bone mineral density, especially in postmenopausal women on greater than replacement doses or in women who are receiving suppressive doses of levothyroxine sodium. The increased bone resorption may be associated with increased serum levels and urinary excretion of calcium and phosphorous, elevations in bone alkaline phosphatase and suppressed serum parathyroid hormone levels. Therefore, it is recommended that patients receiving levothyroxine sodium be given the minimum dose necessary to achieve the desired clinical and biochemical response.

Patients with underlying cardiovascular disease – Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the elderly in whom there is an increased risk of occult cardiac disease. In these patients, levothyroxine therapy should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease. It should be noted that, unlike levothyroxine sodium tablets, TIROSINT capsules cannot be cut in half. If cardiac symptoms develop or worsen, the levothyroxine dose should be reduced or withheld for one week and then cautiously restarted at a lower dose.

Overtreatment with levothyroxine sodium may have adverse cardiovascular effects such as an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias. Patients with coronary artery disease who are receiving levothyroxine therapy should be monitored closely during surgical procedures, since the possibility of precipitating cardiac arrhythmias may be greater in those treated with levothyroxine. Concomitant administration of levothyroxine and sympathomimetic agents to patients with coronary artery disease may precipitate coronary insufficiency.

ADVERSE REACTIONS
The common adverse reactions associated with levothyroxine are primarily those of hyperthyroidism due to therapeutic overdosage including: irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, insomnia, tremors, muscle weakness, change in appetite, weight change, diarrhea, heat intolerance, changes in menstrual periods and skin rash. This is not an exhaustive list. Please refer to TIROSINT's full Prescribing Information for a more comprehensive list of adverse reactions associated with hyperthyroidism.

About Akrimax Pharmaceuticals

Akrimax Pharmaceuticals, LLC is a privately held, innovative specialty pharmaceutical company that acquires, develops and markets advanced ethical prescription medications.  For more information, visit www.akrimax.com.

References

1 Booth, M, 2010. Published online at
http://www.reviewjournal.com/life/health/thyroid-disease-common-us

2 Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado Thyroid Disease
Prevalence Study. Arch Intern Med. 2000;160:526-534.

3 McDermott MT. In the clinic: hypothyroidism. Ann Intern Med. 2009;151(11): ITC-6–ITC-1.

4 Mathur, R : "Hypothyroidism", 2015. Published online at
http://www.medicinenet.com/hypothyroidism/page5.htm

Contacts:
J. Gregory Ford, Akrimax (Business Development)
908-372-1232
gford@akrimax.com

SOURCE Akrimax Pharmaceuticals



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