Regulatory FDA dismisses Amneal's Parkinson's candidate

FDA dismisses Amneal’s Parkinson’s candidate


Amneal Pharmaceuticals were positive about launching their extended-release treatment for Parkinson’s disease this year, which could have led to a potential sales opportunity of $500 million in the US. However, their plans have been delayed. The FDA recently rejected Amneal’s application for IPX203, an oral formulation of carbidopa/levodopa (CD/LD) that combines immediate-release CD/LD granules with extended-release LD-coated beads.

IPX203 is a potential medication for Parkinson’s disease as it uses a unique delivery formula to increase the duration of the drug’s therapeutic effects and reduce involuntary body movements. The goal is to offer more effective treatment with fewer doses than existing formulations.

The FDA’s response to Amneal highlighted concerns about the safety data of the CD component of the drug, emphasizing the need for additional pharmacokinetic information. However, there were no issues identified with the LD element or anything related to the drug’s efficacy, as stated in Amneal’s press release. The company has conveyed its dedication to closely collaborating with the FDA in addressing the provided feedback, while maintaining confidence in expeditiously delivering this innovative treatment to individuals suffering from Parkinson’s disease.

Levodopa has been the standard treatment for Parkinson’s disease for many years, but it often leads to motor complications such as peak-dose dyskinesia. GlobalData analyst Christie Wong explained that the unique formulation of IPX203 requires further scrutiny by the FDA due to its novel characteristics.

Amneal is relying on the approval of IPX203 to maintain its competitive edge in the Parkinson’s disease market, especially considering that its current medication, Rytary, is expected to lose its patent protection in 2028. This loss of exclusivity is predicted to significantly impact Amneal’s sales, according to Wong.

Amneal submitted their application for the extended-release treatment based on data from the successful RISE-PD study conducted earlier. However, it is still uncertain how influential IPX203 will be among doctors and patients. Wong cited interviews with key opinion leaders by GlobalData, indicating that the efficacy advantage of IPX203 over immediate-release LD formulations may not be significant enough to influence treatment patterns, especially if IPX203 is priced at a premium.

Furthermore, IPX203 may face competition from other innovative subcutaneous levodopa delivery systems, such as AbbVie’s ABBV-951 and NeuroDerm’s ND0612, which offer continuous infusion of CD/LD and provide additional options for managing severe motor fluctuations in advanced-stage Parkinson’s patients. ABBV-951 recently encountered its own setback when the FDA questioned the subcutaneous pump device used in the treatment.

IPX203 incorporates various components including a disintegrant polymer for rapid dissolution of the immediate-release granules, a sustained-release polymer for slow drug release, a mucoadhesive polymer to prolong absorption, and an enteric coating to prevent premature disintegration of the beads in the stomach.

While Rytary has achieved limited success, Amneal believes that IPX203 holds the potential to tap into a much larger market for Parkinson’s disease. 

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