Indivior PLC is a holding company, which engages in the development, manufacture and sale of buprenorphine-based prescription drugs for treatment of opioid dependence. Its products include Suboxone Film, Suboxone Tablet, and Subutex Tablet. It operates through the following geographical segments: United States, Rest of World, and United Kingdom. The company was founded on September 26, 2014 and is headquartered in North Chesterfield, VA.
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- Addex Therapeutics announced that its novel GABAB positive allosteric modulator demonstrated robust anti-tussive activity in non-human primate chronic cough models, significantly reducing citric acid-induced cough frequency. - The GABAB PAM candidate showed antitussive efficacy similar to baclofen in primate studies and superior performance compared to nalbuphine, baclofen, codeine, and P2X3 inhibitors in guinea pig models. - The compound demonstrated better tolerability and a wider therapeutic margin than existing treatments, positioning it as a potential once-daily oral therapy for chronic cough patients. - Chronic cough represents a difficult-to-treat condition where current off-label treatments like baclofen are limited by serious side effects including sedation and loss of efficacy over time.
- New research indicates monthly buprenorphine depot injection (SUBLOCADE) demonstrates no increased risk of birth defects or maternal complications when used during pregnancy for opioid use disorder treatment. - The study, published in the American Journal on Addictions, analyzed 322 pregnancy exposures to SUBLOCADE, with case studies showing full-term deliveries and no neonatal opioid withdrawal syndrome. - As opioid-related maternal deaths continue rising, particularly postpartum, this research provides critical evidence supporting SUBLOCADE as a potential treatment option for pregnant patients with OUD.
- Indivior PLC reports FDA has delayed final review of proposed label changes for SUBLOCADE, their extended-release buprenorphine injection for opioid use disorder treatment. - The proposed modifications include updates for rapid initiation protocol and alternative injection sites, with the original PDUFA date set for February 7, 2025. - FDA has confirmed acceptance of the proposed label with no outstanding items to address, though final approval timeline remains pending.
