FDA to reconsider Braeburn's opioid addiction drug after court ruling

A US district court has ruled that the FDA must reconsider its decision to reject a long-lasting opioid addiction treatment drug from Braeburn, overthrowing a ruling granting exclusivity to an established rival from Indivior.

Indivior has done rather well out of a ruling as long ago as 2002 that its Subutex (buprenorphine) opioid addiction treatment should be granted orphan status.

Orphan status usually allows time on the market for rare disease drugs without competitors and was designed to encourage pharma to find drugs to treat conditions affecting only a tiny proportion of the population.

But the FDA granted orphan status to Subutex after Indivior used provisions in the orphan legislation to argue it would be unlikely to recoup its investment in the drug and needed more time without competition.

The FDA agreed and the orphan status was carried on to two new formulations of the drug, based around buprenorphine, including the latest long-lasting monthly dose version Sublocade.

This has allowed Indivior to make billions of dollars in revenue, aided by the lack of competition.

In a ruling yesterday the US District Court in Columbia threw out the FDA’s ruling in December that Indivior had a three-year exclusivity period on Sublocade expiring on November 30 next year.

Braeburn’s application for final approval of a rival weekly or monthly addiction treatment Brixadi (buprenorphine) will be sent back to the FDA for reconsideration with “deliberate speed” following the ruling.

Chief Judge Beryl Howell said the FDA had failed to show its decision on exclusivity was consistent with previous decisions.

The judge also acknowledged the national public health crisis caused by opioid addiction in the US, and the need for other treatment options for patients with opioid use problems.

A spokesperson for Indivior said the company is “continuing to review the decision and its options at this time.”

Braeburn is waiting for a separate decision from the FDA regarding a Citizen Petition, requesting that the regulator should refuse to grant orphan exclusivity to Sublocade on the basis that opioid use disorder is not a bona fide orphan disease.

To qualify for orphan status in normal circumstances, drugs must treat conditions that occur in 200,000 people in the US or fewer. It’s estimated that around 2 million people in the US have opioid addiction problems.

Braeburn’s CEO Mike Derkacz, said: “We look forward to working expeditiously with the FDA to get Brixadi on the market as soon as possible.”