Source – Acadia Pharmaceuticals
ACP-101, also known as intranasal carbetocin, has been chosen by Acadia to move forward into a Phase III research for Prader-Willi syndrome (PWS).
“We recently met with the FDA and reached alignment to further evaluate the 3.2 milligram dose of ACP-101 in a pivotal Phase III study. If positive, we plan to promptly submit a new drug application for the treatment of hyperphagia in PWS to the FDA.”
– Doug Williamson, Acadia’s Executive Vice President, Head of Research and Development
With its acquisition of Levo Therapeutics last year, Acadia gained ownership of the drug’s development rights. PWS is described by Levo as a “rare, life-threatening neurodevelopmental genetic disorder” that affects 8,000 to 10,000 people in the US in an FDA presentation from 2021.
Carbetocin is a medication that has been used for many years to stop excessive bleeding after delivery. The medicine is safe and well tolerated, and according to Levo’s 2021 presentation, it “provides clinically meaningful benefits to patients with PWS.”
Williamson stated that Acadia will apply for FDA approval if the Phase III study is a success.
