FDA issues refusal to file letter for Trevyent (treprostinil + PatchPump technology) for the treatment of pulmonary arterial hypertension.-SteadyMed Therapeutics.

SteadyMed Therapeutics announced receipt of a Refusal to File letter from the FDA relating to its New Drug Application (NDA) for Trevyent (treprostinil + PatchPump technology) for the treatment of Pulmonary Arterial Hypertension (PAH). Based on a preliminary review of the NDA, which was submitted in June 2017, the FDA determined that the application is not sufficiently complete to permit a substantive review. FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product.

Within the next 30 days, the Company will request a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The Company will provide further guidance after the anticipated meeting with FDA. 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 capable of delivering treprostinil subcutaneously or intravenously.