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Akrimax Pharmaceuticals Initiates CONTROL Patient Registry for Tirosint® (levothyroxine sodium) Capsules

Post-marketing study to assess efficacy and tolerability of Tirosint in hypothyroid patients inadequately controlled with traditional T4 therapy

Cranford, NJ (June, 2014) – 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.

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