Specialized Pharmaceutical Company SteadyMed Ltd. recently announced the completion of its program on human factors studies involving its flagship product candidate, Trevyent (treprostinil sodium), which is currently undergoing testing as a potential new treatment for pulmonary arterial hypertension (PAH).
Trevyent is currently the only FDA-approved parenteral treatment for PAH, deliverable via intravenous and subcutaneous route that is paired with SteadyMed’s proprietary PatchPump technology. It is a discreet, single-use, pre-filled with the pump and is pre-programmed to deliver the prescribed dose at the correct rate.
“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.”
These human factors studies are essential milestones for drugs seeking final authorization to be used with a specific device. The products are subject to rigorous evaluation and fine tuning throughout their development before concluding with a summative study to verify their advantage and safety to patients. Since SteadyMed’s introduction of its human factors program, the company has funded 8 studies for Trevyent, successfully enrolling 148 patients in both the US and in Europe. These included 92 patients with PAH, 33 providers, and 23 supplementary participants.
In a previous report on Trevyent, SteadyMed together with Cardiome Pharma Corp announced an exclusive agreement for Cardiome to market Trevyent in specific markets outside the United States if Trevyent receives approval to treat pulmonary arterial hypertension (PAH) in those regions. The license agreement stipulates that SteadyMed will receive $12.25 million linked to regulatory and sales milestones, and will include a $3 million upfront payment. In addition, Cardiome will pay royalties on future sales of Trevyent to SteadyMed. This exclusive partnership includes Canada, Europe and the Middle East.
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