24th Feb 2025 10:50
(Alliance News) - Indivior PLC on Monday said the US Food & Drug Administration has approved label changes for its opioid use disorder treatment Sublocade, allowing for faster initiation and more flexible administration options.
The Richmond, Virginia-based pharmaceutical company said healthcare providers can now start treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period, significantly reducing the previous one-week waiting period.
Additionally, the FDA approved new injection sites, allowing Sublocade to be administered in the abdomen, thigh, buttock, or upper arm, giving both patients and providers more flexibility.
"These enhancements not only reflect our commitment to patient-centered care but also our ongoing efforts to align our treatments with real-world clinical needs, thereby potentially improving patient adherence and outcomes," said Chief Scientific Officer Christian Heidbreder.
Indivior said the label changes do not affect the drug's safety or efficacy but could improve access to treatment and patient retention. A clinical study of 729 participants showed that over 66% of patients who received the rapid initiation injection proceeded to a second dose, compared to 55% under the previous protocol.
Shares in Indivior were down 2.7% at 670.00 pence in London on Monday morning.
By Eva Castanedo, Alliance News reporter
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