SteadyMed Therapeutics (NSDQ:STDY) today detailed the development of its lead drug candidate, Trevyent (treprostinil sodium), for the treatment of pulmonary arterial hypertension using its PatchPump tech at the Parenteral Drug Assn. Conference in Huntington Beach, Calif.
PatchPump is the 1st single-use, wearable, pre-filled pump and treprostinil will be the 1st drug integrated with the delivery system, according to the San Ramon, Calif.-based company.
The pump uses a self-powered expanding battery actuator, a semi-flexible container, a printer circuit board assembly for controlling the delivery rate, a proprietary infusion set, and an adhesive patch.
Treprostinil is 1 of 2 therapies on the market indicated for pulmonary arterial hypertension and “both require cumbersome and potentially risky manipulation of drug formulations and device programming on an almost daily basis in order for patients to receive their therapy,” the company explained on its poster. SteadyMed avoids this problem by design, since Trevyent is pre-filled and pre-programmed.
The primary drug container is made from a flexible, thermo-formed film that is heat-sealed onto a base plate, according to SteadyMed. The company explained its development plan from compounding and filling the drug container, to assembly and calibration of the patch.
The company also provided stability data, showing that over 18 months of storage the drug was still at 100% of label claim for all 3 strengths.
Upon completion of the industrialization process and pilot-scale production in 2016, the company is aiming for US regulatory submission and approval in 2017.
“Trevyent overcomes many of the limitations of using general use or insulin infusion pumps for PAH therapy,” SteadyMed wrote. “If approved, Trevyent will fulfill an unmet medical need and will be the 1st parenteral product for PAH that has been custom-designed specifically to meet the needs of PAH patients.”
