SAN RAMON, Calif., Dec. 7, 2015 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced the results of a non-clinical animal study, which evaluated the potential effect of the company's preservative-free Trevyent® formulation on reducing the significant subcutaneous infusion site pain often associated with United Therapeutics' (Nasdaq:UTHR) Remodulin®, the market leading prostacyclin used to treat pulmonary arterial hypertension (PAH). Trevyent is a development-stage drug product candidate not yet approved by the FDA that is a combination of SteadyMed's PatchPump® and treprostinil formulated without the preservative meta-cresol. Remodulin is supplied in a multi-dose vial that contains treprostinil and by necessity the preservative meta-cresol.
"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 Chief Executive Officer of SteadyMed. "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 representative of Trevyent and Remodulin were tested in an animal model via continuous subcutaneous infusion for 7 days. Tactile sensitivity, an indicator of local site pain, was evaluated using a variety of endpoints on Day 1 (baseline), on Day 3 and on Day 7. The results from testing with an Electronic Von Frey probe, relative to baseline and placebo-corrected, showed a significant reduction in skin pain sensitivity with SteadyMed's preservative-free drug formulation compared to the drug formulation with preservative, representative of Remodulin.
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. The company's lead drug product candidate is Trevyent®, a development stage drug product that combines SteadyMed's PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension. PatchPump is a proprietary, disposable, parenteral drug administration platform that is prefilled and preprogrammed at the site of manufacture. SteadyMed intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning the company's ability to advance its development-stage product candidates, including Trevyent. Forward-looking statements reflect the company's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q filed on November 12, 2015. The company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof except as may be required by law.
Source: SteadyMed Therapeutics