SteadyMed announced it has received a U.S. patent for its PatchPump infusion system for injectable drugs, including Trevyent, the company’s lead candidate as a potential treatment for pulmonary arterial hypertension (PAH).
The patent, issued by the U.S. Patent and Trademark Office (No. 14/384,152), includes but is not limited to claims for a pump assembly comprising a sealed, prefilled drug reservoir for the infusion of drugs.
The PatchPump technology will, upon approval, initially be used as the infusion system for Trevyent.
Trevyent consists of treprostinil, a vasodilatory prostacyclin, delivered via the PatchPump system. Treprostinil is the only parenteral treatment approved for both intravenous (IV) and subcutaneous (SC) administration.
Remodulin injection is the market-leading treatment PAH, and is a formulation of treprostinil that allows delivery through IV and SC routes. However, Remodulin contains the preservative meta-cresol, which is often associated with injection site pain.
In contrast, Trevyent does not contain any preservatives. The PatchPump is pre-filled with the drug, and its delivery rate can be pre-programmed. The technology uses sensors to give patients audible and visual feedback on successful drug administration and end of dosing.
Trevyent’s PatchPump delivery system was recently shown to be effective, safe and tolerable in a company study conducted in 60 healthy volunteers in a clinic. Each participant received a PatchPump containing a placebo to use, and the study assessed the device’s performance and safety as a delivery system. It performed as intended in all categories, SteadyMed announced in April.
“The grant of this patent potentially further protects not only Trevyent, but our proprietary PatchPump, prefilled, pre programmed, sterile and disposable infusion system,” Jonathan Rigby, president & ceo of SteadyMed, said in a press release.
In January 2016, Trevyent was designed an Orphan Drug by the U.S. Food and Drug Administration (FDA) for the treatment of PAH. The company is planning to submit a New Drug Application (NDA) for Trevyent to the FDA by mid-year.
PAH, a rare disease, occurs when the pressure in the blood vessels leading from the heart to the lungs is too high, causing shortness of breath, dizziness, fainting, leg swelling and other symptoms.