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Akrimax Announces Publication of CONTROL Surveillance Project Results

First in three-part research program

Cranford, NJ (January, 2016) – 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 liebertpub.com.

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.

Contacts

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