Company to meet and work with FDA to agree on pathway to Trevyent NDA resubmission
SAN RAMON, Calif., Sept. 28, 2017 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that it has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA).
The Type A meeting is being requested in response to the FDA’s August 28, 2017 Refusal to File (RTF) letter relating to SteadyMed’s New Drug Application (NDA) for Trevyent®, its lead drug product candidate that is in development for the treatment of Pulmonary Arterial Hypertension (PAH). The Meeting Request and Briefing Document contain SteadyMed’s proposals to address the issues raised by the FDA in the RTF letter, along with a request for a Type A meeting to obtain agreement on SteadyMed’s proposed pathway to a Trevyent NDA resubmission. Per FDA guidance to industry, a Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. If granted, Type A meetings are generally scheduled within 30 days of the meeting request.
“We believe that we have provided a Briefing Document that will allow us to work collaboratively with FDA to agree on a pathway to resubmission of our NDA for Trevyent,” said Jonathan M. N. Rigby, President and CEO of SteadyMed. “We look forward to meeting with FDA in the near future.”
Designed to address the limitations of existing PAH therapies, SteadyMed’s investigational drug product Trevyent, combines its preservative-free, parenteral treprostinil formulation with the Company’s proprietary PatchPump®, in a sterile, pre-filled, pre-programmed, single use disposable infusion system for parenteral delivery of treprostinil.
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. 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 about the company's intentions to meet with the FDA and re-submit its New Drug Application for Trevyent and 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 Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that the Trevyant NDA is not accepted for filing by the FDA, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will continue to need additional funding, and that the company may be unable to raise capital when needed, which would force the company to delay, reduce or eliminate its product candidate development programs and potentially cease operations. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q filed on August 11, 2017. 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.
Senior Director, Investor Relations and Marketing
The Ruth Group