SteadyMed, a pharmaceutical company whose focus is the development of products to treat orphan diseases with unmet clinical needs, has announced promising results from an animal study evaluating the efficacy of its lead drug product Trevyent® in the reduction of the pain associated with the use of United Therapeutics’ Remodulin® to treat pulmonary arterial hypertension (PAH).
Trevyent, currently in the development stage and not yet approved by the U.S. Food and Drug Administration (FDA), combines the delivery system PatchPump with treprostinil, a vasodilatory prostacyclin and only parenteral treatment approved for both intravenous (IV) and subcutaneous (SC) administration. Remodulin injection is the market leading drug for PAH treatment, a formulation of treprostinil that allows delivery through IV and SC routes but that contains the preservative meta-cresol, which is often associated with post-injection site pain. Trevyent, in contrast, does not contain any preservatives. The PatchPump is pre-filled with the drug, whose delivery rate can be pre-programmed. The technology uses sensors to also give patients audible and visual feedback on successful drug administration and end of dosing.
The study tested subcutaneous infusion delivery of both formulations, representative of Trevyent and Remodulin, in an animal model for seven days. The study endpoints were tactile sensitivity, a local pain measure, on day one (baseline), and days three and seven. Results show that animals injected with the Trevyent-like preservative-free formulation experienced a substantial reduction in local pain sensitivity when compared to the animals receiving the Remodulin formulation.
“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. 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,” Jonathan Rigby, president and chief executive officer of SteadyMed, said in a press release. “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.”