For opioid use disorder, buprenorphine works.

BUT CHALLENGES REMAIN:

  • Studies indicate that daily medication compliance is only 72%, which negatively impacts treatment success.

  • More than 40% of prescribed buprenorphine is diverted.

  • Treatment drop-out typically happens around Day 100 of treatment: far too early.

  • Public safety concerns persist, as buprenorphine was the most common active ingredient in emergency hospitalizations of children five years old or younger from 2007-2011.

Our pending combination product prepackages buprenorphine-naloxone with MedicaSafe's proprietary technology

  • EASY PRESCRIBING, PHARMACY DISPENSING
    Certified pharmacy partners handle system set-up and distribution
  • GUIDING COMPLIANCE AND ENFORCING FLOW CONTROL
    A provider prescribes a target dose and maximum limit, and the SmartKey guides the patient
  • TRACKING AND REPORTING USAGE
    Clinicians can access reports on medication usage pattern whenever desired

Why: Improve drug safety, risk stratification, and patient engagement

  • TREATMENT ADHERENCE PROGRAM
    Intentionally invokes the "Hawthorne Effect" to promote daily med compliance; Discourages improper access via "Dynamic Flow Control"
  • RISK-ASSESSMENT REPORTS
    Reveal patterns of poor compliance, misuse, or tampering; Satisfy FDA REMS requirements and DEA recordkeeping rules
  • DETER UNAUTHORIZED ACCESS
    Oral buprenorphine products have elevated rates of child poisonings. Secure cartridges deter unauthorized access by children and others

Research indicates positive effect

graph

MedicaSafe patients took medication as prescribed 97% of days (CI 94% to 100%) in a community treatment setting. A reference value for treatment as usual daily compliance is 72% (CI 68% to 76%).

Partners

Friends Reseach Institute
Veterans Affairs Hospital, Puget Sound

STUDIES SUGGEST:

Patient compliance - taking the right dose of prescribed buprenorphine at the right time - is associated with better success rates in addiction treatment.

Conversely, poor compliance correlates with heightened risk of illicit opioid use.

Sharing and selling of buprenorphine is commonly reported. So the DEA compels prescribers to track patients carefully and compile detailed records.

All of this contributes to a need for safe, effective prescription monitoring, so treatment can be available to more people.

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