Spectrum Pharmaceuticals' (SPPI) conditioning treatment in autologous transplants in multiple myeloma, Captisol-enabled (propylene glycol-free) Melphalan (CE Melphalan) meets its primary endpoint of determining the overall safety and toxicity profile in multiple myeloma patients receiving 200mg/m2 of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation.
Propylene glycol is associated with undesirable renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds.
A previous clinical trial established bioequivalence to the currently-available IV formulation of melphalan.
The company plans to file an NDA in Q3.
The FDA granted Orphan Drug Designation to the product for this indication.