SteadyMed Ltd., a pharmaceutical company focused on developing drugs for the treatment of orphan and high value diseases, has announced positive data from an animal study assessing the clinical effects of its Trevyent® (preservative-free treprostinil) formulation in reducing the significant pain at the subcutaneous infusion site often associated with United Therapeutics’ Remodulin®, the leading prostacyclin for the treatment of pulmonary arterial hypertension (PAH).
Treprostinil is the only parenteral treatment for PAH approved by the U.S. Food and Drug Administration (FDA) for both intravenous (IV) and subcutaneous (SC) administration. The preservative-free treprostinil delivered via the PatchPump technology is branded by SteadyMed as Trevyent, and is a development-stage drug product not yet approved by the FDA. Remodulin is supplied in a multi-dose vial that contains treprostinil and, of necessity, the preservative metacresol.
Trevyent is a small and discreet, single-use (2 day) PatchPump. It is pre-filled with Trevyent and pre-programed at the correct delivery rate. PatchPump is equipped with sensors to provide patients audible and visual feedback on successful delivery and end of dosing.
“The results of this preclinical investigation support the findings in the scientific literature regarding the adverse effect of local site pain associated with injection products containing the preservative meta-cresol,” said Jonathan Rigby, president and CEO of SteadyMed, in a press release. “Severe infusion site pain affects more than 80 percent of patients with PAH taking subcutaneous Remodulin, with an estimated 30 percent resorting to narcotic pain relievers in order to continue treatment. We believe Trevyent’s preservative-free formulation, if approved, has the potential to reduce the prevalence or severity of infusion site pain for PAH patients, and we look forward to confirming these results in future clinical studies.”
Formulations of Trevyent and Remodulin were examined in an animal model via continuous subcutaneous infusion for a period of seven days. Tactile sensitivity, which indicates local site pain, was assessed with a variety of endpoints at baseline (day one), and at days three and seven.
Results from an Electronic Von Frey probe testing, relative to baseline and placebo-corrected, demonstrated a reduction in tactile sensitivity with SteadyMed’s preservative-free formulation in comparison to the drug formulation with preservative, representative of Remodulin.
PAH is a life threatening, progressive disease caused by narrowing or tightening (constriction) of the pulmonary arteries that connect the right side of the heart to the lungs. There is no cure, and the disease’s most common symptoms include breathlessness, fatigue, weakness, angina, syncope, and abdominal distension.
PAH disease progression requires pharmacologic intervention. While treatment patterns vary and therapies are tailored to meet an individual’s needs, the typical progression of drug therapy will incorporate parenteral compounds in more advanced stages of the disease. Prostacyclin-based therapy is currently the only parenteral option approved for use for the management of PAH.
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