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news.CyDex Pharmaceuticals, a specialty pharmaceutical company, has received orphan-drug designation from the FDA for melphalan 'as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation'.
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Currently under development, CyDex’s new intravenous formulation of melphalan is enabled by Captisol – the company’s proprietary and patented sulfobutylether beta-cyclodextrin. Melphalan is an FDA-approved chemotherapy for multiple myeloma marketed under the brand name Alkeran by GlaxoSmithKline.
Alkeran is packaged as two separate vials that must be combined prior to use and, due to its limited stability, administered shortly thereafter. Captisol-Enabled melphalan is a one-vial formulation with extended room-temperature stability and does not contain harsh co-solvents, the company said.
Theron Odlaug, president and CEO of CyDex, said: “Receiving FDA orphan-drug designation for melphalan is an important step for CyDex as we develop our retained product pipeline. Creating a chemotherapy product with improved ease of administration has the potential to advance the treatment of cancer.
“It is also a key initiative in CyDex’s core strategy, which is to develop and market our own line of specialty pharmaceutical injectable products. We look forward to moving Captisol-Enabled melphalan through the clinical development and FDA review process.”