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Indivior Announces FDA Approval of SUBLOCADE Label Changes

Why we think this is good

The RNS outlines several positive updates to the SUBLOCADE label, including a rapid initiation protocol and alternative injection sites. These changes are expected to improve patient access and adherence to this important treatment for opioid use disorder. There are no obvious negative factors or concerns raised in the announcement.

Key Points

  • FDA approved label changes for SUBLOCADE (buprenorphine extended-release) Injection
  • Rapid initiation protocol reduces time to treatment from 1 week to 1 hour
  • Alternative injection sites provide more flexibility for patients and healthcare providers
  • Changes expected to improve patient adherence and outcomes

Summary

The pharmaceutical company announces FDA approval of label changes for its opioid use disorder treatment SUBLOCADE, including a rapid initiation protocol and alternative injection sites.

Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, announced that the U.S. FDA has approved label changes for SUBLOCADE® (buprenorphine extended-release) Injection. The key changes include a rapid initiation protocol that reduces time to treatment from 1 week to 1 hour, as well as the ability to administer SUBLOCADE at alternative injection sites. These updates are expected to improve patient access and adherence to this important treatment for opioid use disorder.

GENERAL UPDATE