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FDA Rejects Supernus Pharma’s Minimally Invasive Parkinson’s Therapy

Supernus Pharmaceuticals Inc (NASDAQ:SUPN) received FDA’s complete response letter (CRL) for the SPN-830 marketing application. SPN-830 is an investigational apomorphine infusion…
byVandana Singh
October 10, 2022
1 minute read
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  • Supernus Pharmaceuticals Inc (NASDAQ:SUPN) received FDA’s complete response letter (CRL) for the SPN-830 marketing application.
  • SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
  • The CRL requires additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance, and risk analysis. 
  • Related: FDA Approves Expanded Use Of Supernus’ Viloxazine In Adult ADHD Patients.
  • In addition, the FDA mentions that approval requires inspections that could not be completed on time due to COVID-19 travel restrictions. 
  • The CRL does not request additional efficacy and safety clinical studies.
  • The FDA has determined that the amendment to the Company’s application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
  • Last year, Supernus acquired Adamas Pharmaceuticals for $9.10 per share, or $450 million, to strengthen its Parkinson’s disease portfolio.
  • Price Action: SUPN shares are down 11.4% at $29.50 during the premarket session on the last check Monday.
 
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