Braeburn Gets CRL For CAM2038 In Opioid Use Disorder, Yields Ground To Indivior
Executive Summary
Braeburn was in a position to launch its buprenorphine injection CAM2038 within a month and a half of its Jan. 19 PDUFA date, putting the opioid addiction therapy on the market around the same time as Indivior's Sublocade, but now there may be several months between the products' launches.
You may also be interested in...
US FDA, Advisory Committees Rarely Disagree
A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
Blocked By Sublocade: Braeburn Sues To Get Brixadi Buprenorphine Formulation Onto Market
Lawsuit against US FDA challenges scope of three-year exclusivity awarded to Indivior’s Sublocade, the first monthly depot formulation of buprenorphine for treating opioid use disorder.
2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections
US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.