That would mean Braeburn wouldn’t be able to sell its similar version of the medication, Brixadi, for several more years. The company argues that’s unfair, considering opioid addiction is hardly a rare disease and Indivior has already collected large profits from oral versions of buprenorphine.”You can’t say opioid use disorder is an orphan disease because you have over 2 million patients who have that disease,” Braeburn CEO Mike Derkacz told me yesterday.While “orphan drug” designations have been hugely helpful for patients whose illnesses might be otherwise ignored, drug makers have also manipulated the system to maximize profits.Let’s zoom out for a moment. There’s broad consensus that combining counseling services with medication assisted treatment is the best way to help people who are addicted to prescription painkillers, heroin or the synthetic opioid fentanyl.Health and Human Services Secretary Alex Azar has stressed it must be a central part of the administration’s response to the opioid crisis, and in February the FDA issued guidance praising the effectiveness of buprenorphine and giving advice on how pharmaceutical makers could get more such medications approved.First Lady Melania Trump participates in a town hall meeting on opioids at Liberty University in November 2018.

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