Titan Pharmaceuticals (NASDAQ:TTNP) has added an implantable triiodothyronine (T3) product for the treatment of hypothyroidism to its product development pipeline.
Hypothyroidism affects about 15 million Americans, mostly women. The majority of patients receive treatment typically consisting of synthetic prohormone thyroxine (T4) given as a once-daily oral medication, which in turn is converted in the body to the active T3.
Based on symptoms and blood tests, an estimated 15% to 20% of hypothyroid patients are not adequately treated with this therapy, resulting in a persistent deficiency in the primary active form of thyroid hormone, T3, and physicians typically add an oral T3 regimen to the treatment of these patients.
In a statement, Titan EVP and chief development officer, Kate Beebe, said once-daily synthetic T3 (Cytomel) is an effective medication for hypothyroidism but can come with potential side effects, such as headache, nervousness, irritability, sweating, and cardiac arrhythmias, which are caused by the peak-and-trough blood-level fluctuations of T3 associated with standard oral delivery.
“Continuous delivery of T3 by the oral or parenteral route is highly desirable, but has been difficult to achieve because of the unique solubility characteristics of the compound,” she added. “An implantable T3 product utilizing the ProNeura platform that more closely replicates normal thyroid physiology and avoids the unwanted side effects associated with the current pulsatile-release oral formulation could benefit patients and serve a great, unmet medical need.”
Sunil Bhonsle, president, said the development of ProNeura for hypothyroidism could present a significant market opportunity.
The company’s lead product candidate, Probuphine, is being developed for the long-term maintenance treatment of opioid addiction. The FDA has accepted for review a NDA for Probuphine and has set an action date of Feb. 27, 2016 on the NDA.
Titan is also developing a ProNeura implant containing ropinirole, a dopamine agonist, for the treatment of Parkinson’s disease and expects to commence clinical testing of its product candidate by the end of next year.