FDA Clinical Inspection Summary: Movantik (naloxagol oxalate) submitted by Astra Zeneca

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Movantik (naloxagol oxalate) submitted by Astra Zeneca.  Four sites plus the sponsor were selected for inspection. Sites were selected based on enrollment and the output of the FDA risk analysis tool. Site inspections ranged over one week to four weeks and the sponsor inspection lasted just over one week. Two sites received FDA Form 483s.

Dr. Foley received a 483 for failing to follow the investigational plan and failing to maintain adequate records, specifically:

  • Enrolling one subject on a prohibited concomitant medication that was known to prolong the QT interval on ECG
  • Enrolling one subject who exceed the limits for QTcF at the screening ECG
  • Enrolling eight subjects without the required cancer screening at baseline. (FDA notes that this was likely a documentation issue, as there was evidence that colonoscopies had taken place.)
  • Enrolling one subject who was not on a stable dose of opioids
  • Discrepancies for three subjects in opioid doses

Dr. Sanapati was cited for failing to follow the investigational plan, specifically:

  • Enrolling two subjects who were taking protocol prohibited medications that prolonged the QT interval