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Sandoz Receives FDA's Clearance for reSET-O- a Medical Mobile App for Opioid Use Disorder (OUD)

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Sandoz Receives FDA's Clearance for reSET-O- a Medical Mobile App for Opioid Use Disorder (OUD)

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  • The approval is based on trial results assessing reSET-O in 170 patients receiving either treatment-as-usual (TAU) + standard clinician interactions + buprenorphine or reSET-O + standard clinician interactions + buprenorphine for 12 wks.
  • The study demonstrated improved and increase rates of retention time with efficacy results in patients with OUD
  • reSET-O is a FDA approved Prescription Digital Therapeutic mobile medical application for 12 weeks- delivering a cognitive behavioral therapy for OUD patients aged ≥18 yrs. In Nov 2018- reSET received FDA approval for Substance Use Disorder (SUD)

Ref: Novartis | Image: Medical Product Outsourcing

Click here to­ read the full press release 

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