Corsair Pharma, a private company in California, had a positive pre-investigational new drug meeting with the United States Food and Drug Administration about its once-daily treprostinil patch (TRX-248 Transdermal System) for pulmonary arterial hypertension.
The Food and Drug Administration supported the company’s plan to seek approval through a shorter regulatory route (the 505(b)(2) pathway). That route relies partly on the earlier safety and effectiveness findings for Remodulin.
To use that route, Corsair must show that the patch gives the same treprostinil levels in the blood as Remodulin given by injection under the skin.
The patch carries an inactive form of the drug that passes through the skin and turns into treprostinil once absorbed. It is meant to give steady levels over 24 hours without a pump, needle or inhaler. Different patch sizes are planned so the dose can be adjusted easily.
In an early study in healthy volunteers, the patch kept treprostinil levels steady over 24 hours and was well tolerated.
It is the only transdermal prostacyclin at the clinical stage.
Timeline:
- A pilot study comparing the patch with Remodulin starts in early 2027.
- The main comparison study starts in late 2027.
- Results from the main study are expected by mid-2028.
Read more at this link on Biospace
See also our previous article on this topic here