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Buvidal Given Positive Recommendation, Approval by European Committee

Plus: a list of other opioid dependence medications currently approved

A PPM Brief

Camurus (Lund, Sweden), a partner of Braeburn (Plymouth Meeting, PA), announced1 the positive opinion and recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the approval of Buvidal (buprenorphine, CAM2038), a prolonged-release injection solution for the treatment of opioid dependence in adults and adolescents older than 16 years of age.

The positive opinion comes from a comprehensive clinical program of seven clinical studies, including a randomized, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. The results from this study demonstrated that Buvidal provided improved treatment outcomes compared to daily standard treatment with sublingual buprenorphine/naloxone.

Final marketing authorization for Buvidal was granted by the European Commission in late November 2018,2 making it the first approved long-acting treatment for opioid dependence in the EU. “Buvidal weekly and monthly subcutaneous injection depots could become a game-changer in opioid dependence treatment by improving adherence and reducing the burden, stigma and risks of daily treatment,” said John Strang, MD, director of the National Addiction Centre at King’s College in London.

CAM2038 is currently under review for marketing authorization in the US, where FDA has issued a PDUFA goal date of December 26, 2018.

Detoxing from Opioid DependenceMedication-assisted treatment (MAT) has been a huge aspect of combating opioid misuse and abuse. (Source: 123RF)

Similar Medications Approved

Several other opioid dependence and opioid withdrawal or discontinuation medications have been approved in the US to date, including:

  • Belbuca (BioDelivery Sciences International, Raleigh, NC)
  • Buprenex (Reckitt Benckiser Pharmaceuticals, Richmond, VA)
  • Butrans (Orexo US, Morristown, NJ)
  • Lucemyra (Salix Pharmaceuticals, Bridgewater Township, NJ)
  • Probuphine (Braeburn Pharmaceuticals)
  • Revia (Teva Pharmaceuticals, Petah Tikva, Israel)
  • Suboxone (Indivior, North Chesterfield, VA)
  • Vivitrol (Alkermes, Dublin, Ireland)
  • Zubsolv (Orexo US, Morristown, NJ)
Last updated on: December 10, 2018
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