Spectrum Submits NDA for Propylene Glycol-Free Melphalan
Spectrum announced the submission of a New Drug Application (NDA) for Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
The propylene glycol-free formulation eliminates the need for a custom diluent in reconstitution, avoiding the toxicity risks associated with that excipient. In addition, the Captisol technology enhances the stability of Melphalan, allowing for slower infusion rates and longer administration durations.
A Phase 2, multi-center trial evaluated the safety and efficacy of CE-Melphalan. The primary objective of overall safety and toxicity profile in multiple myeloma patients receiving 200mg/m2 of CE-Melphalan as myeloablative therapy prior to autologous stem cell transplantation was met. CE-Melphalan also met the requirements for establishing bioequivalence to the currently available IV formulation of melphalan in a separate clinical study.
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