Utilizing its unique drug delivery capabilities, Catalent partnered with VIVUS during the development of Qsymia, including pre-formulation and formulation, clinical supply and validation.
Qsymia has recently been approved by the FDA as the first once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related co-morbidity.
“It is extremely exciting for Catalent to see the FDA approval of this significant new therapy for weight management. As a combination therapy with two active ingredients that needed to be formulated and delivered in a controlled release dosage form, Qsymia presented unique formulation and drug delivery challenges. We are very pleased to have partnered with VIVUS in developing Qsymia and look forward to a long and successful relationship,” commented Dr. Ian Muir, President of Catalent's Modified Release Technologies business.
Peter Tam President of VIVUS added, “An extendedrelease formulation of Qsymia was critical to achieving our aim of developing a once-daily treatment. Catalent's broad range of drug delivery capabilities and extensive experience in controlled-release technologies helped us to achieve our goal. VIVUS is also pleased to have completed a long-term commercial supply agreement with Catalent to ensure the reliable on-going supply of Qsymia.”
Qsymia has recently been approved by the FDA as the first once-daily combination treatment for chronic weight management in adults who are obese or overweight with a weight-related co-morbidity.
“It is extremely exciting for Catalent to see the FDA approval of this significant new therapy for weight management. As a combination therapy with two active ingredients that needed to be formulated and delivered in a controlled release dosage form, Qsymia presented unique formulation and drug delivery challenges. We are very pleased to have partnered with VIVUS in developing Qsymia and look forward to a long and successful relationship,” commented Dr. Ian Muir, President of Catalent's Modified Release Technologies business.
Peter Tam President of VIVUS added, “An extendedrelease formulation of Qsymia was critical to achieving our aim of developing a once-daily treatment. Catalent's broad range of drug delivery capabilities and extensive experience in controlled-release technologies helped us to achieve our goal. VIVUS is also pleased to have completed a long-term commercial supply agreement with Catalent to ensure the reliable on-going supply of Qsymia.”
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