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Akrimax Pharmaceuticals Initiates CONTROL Patient Registry For Tirosint® (Levothyroxine Sodium) Capsules


7/29/2014 10:32:43 AM

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CRANFORD, N.J., July 29, 2014 (GLOBE NEWSWIRE) -- Akrimax Pharmaceuticals, LLC, a privately held, innovative specialty pharmaceutical company, today announced the initiation of its patient registry study in hypothyroidism called CONTROL: CONversion to Tirosint Results in better management of hypOthyroidism and improved quality of Life. The post-marketing study will assess the efficacy and tolerability of Tirosint® (levothyroxine sodium) capsules in hypothyroidism patients who are inadequately controlled with, or intolerant of, traditional levothyroxine (T4) tablets. Tirosint, the first and only T4 available in a liquid gel cap, is approved by the U.S. Food and Drug Administration for the treatment of hypothyroidism.

CONTROL is an open-label observational study in which patients who have not previously achieved target thyroid-stimulating hormone (TSH) levels with traditional T4 tablets will be switched to Tirosint at a dose deemed appropriate for the individual. TSH levels will be measured every 4-6 weeks and dose titrations will be made, as needed. In addition, patients will complete a quality of life survey called ThyTSQ before starting Tirosint and at the end of the treatment period. The study is expected to enroll patients at sites throughout the U.S. starting immediately.

Charles Pollack, MD, lead study investigator and Chief Medical Officer of Transition Patient Services, said, "Patients with hypothyroidism, particularly those who also have gastrointestinal disorders like celiac disease and H. pylori infection, may have trouble tolerating or absorbing traditional T4 tablets. This hinders them from achieving normal TSH levels. CONTROL will evaluate Tirosint therapy in these patients in order to provide documentation of Tirosint's effectiveness and tolerability, as well as offer insights about hypothyroid patients' quality of life before and after Tirosint treatment. We anticipate having results by early 2016 and look forward to publishing our findings to help better inform hypothyroidism treatment decisions."

CONTROL has been approved by the Western Institutional Review Board.

About Hypothyroidism

Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. More than 27 million adult Americans have been diagnosed with hypothyroidism,1 and 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 Common symptoms of hypothyroidism 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 are pure. 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).

IMPORTANT SAFETY INFORMATION

WARNINGS

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.

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.

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 also contraindicated for anyone who may be unable to swallow a capsule (e.g., infants, small children).

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 and 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

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage such as fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating, and other adverse reactions. 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.

For Tirosint full Prescribing Information, go to www.Tirosint.com.

About Akrimax Pharmaceuticals

Akrimax Pharmaceuticals, LLC is a privately held, innovative specialty pharmaceutical company that acquires, develops and markets advanced ethical prescription medications. Akrimax's marketed products include: SuprenzaTM, PrimlevTM, Tirosint®, NitroMist®, Inderal LA®, and InnoPran XL®. In order to bring the best treatments to patients, Akrimax is continuously evaluating opportunities to partner with other organizations that strive to improve patient care. For more information, visit www.akrimax.com.

References

1 Springer, G. 2011. Published online at: www.personalhealthconnections.com/2011/thyroid-disease-why-this-epidemic

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 "FAQ: Hypothyroidism" American Thyroid Association, 2012. Published online at: http://www.thyroid.org/faq-hypothyroidism/

CONTACT: J. Gregory Ford, Akrimax (Business Development) 908-372-1232 gford@akrimax.com Annie Starr, 6 Degrees (Media) (973) 415-8838 astarr@6degreespr.com
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