placebo + IPX056

IPX056 is an investigational extended-release (ER) formulation of baclofen, a small molecule GABA-B receptor agonist, developed by Impax Laboratories (now Amneal Pharmaceuticals). It is designed as a proprietary sprinkle capsule intended to provide a prolonged duration of absorption, reduce dosing frequency, and improve symptom control compared to immediate-release baclofen. The drug was primarily studied for the treatment of spasticity associated with multiple sclerosis (MS). In clinical trial contexts, "placebo + IPX056" typically refers to a treatment arm where patients receive the active IPX056 formulation alongside a placebo, often as part of a double-dummy study design to maintain blinding against an immediate-release comparator. IPX056 met clinical endpoints in Phase 3 studies, demonstrating statistically significant reductions in spasticity (measured by the Ashworth score) and improvements in morning stiffness and nighttime awakenings compared to conventional baclofen and placebo.

Other names

baclofen ERextended-release baclofenIPX056 sprinkle capsuleIPX-056 sprinkle capsuleIPX 056 sprinkle capsule