SAN RAMON, Calif., July 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 completion of its program of human factors studies for its lead drug product candidate, Trevyent, which is in development for the treatment of pulmonary arterial hypertension (PAH).
"We are delighted to announce the completion of our two year program of human factors studies for Trevyent," said Jonathan M. N. Rigby, President and CEO of SteadyMed. "This milestone fulfills a critical requirement of our NDA (U.S.) and MAA (Europe) submissions which are planned for Q1 2016 and mid-2016 respectively, given that our biowaiver negates the need for us to conduct lengthy and expensive clinical trials in order to gain approval for sale. Our human factors studies were conducted in accordance with all applicable regulatory guidelines to evaluate and refine Trevyent, in an iterative manner, for use by PAH patients and their caregivers. The series of 8 studies demonstrates that Trevyent meets the use requirements of its intended purpose."
Human factors studies are necessary for potential drug products seeking regulatory approval in combination with a device. Such products must undergo evaluation and refinement throughout their development, culminating in a summative study to demonstrate their utility and safety to patients and end-users. Since the inception of SteadyMed's program of human factors studies in 2013, the company has sponsored 8 human factors studies for Trevyent, enrolling a total of 148 subjects in the U.S. and Europe, including 92 PAH patients, 33 healthcare providers and 23 additional participants. The completion of this extensive program of human factors studies validates the usability of Trevyent by patients with PAH.
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. In June 2015, SteadyMed signed a licensing 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 May 14, 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