Drugs

Braeburn Wants Sublocade Orphan Designation Dropped

Braeburn is petitioning FDA to revoke the orphan drug designation for Invidior’s Sublocade (buprenorphine extended-release) injection for treating opioid use disorder. The company’s petition calls on FDA to refuse to grant a seven-year orphan drug exclusivity for Sublocade. Braeburn says the exclusivity would likely prevent approval of any other opioid use disorder buprenorphine product, including its own Brixadi (buprenorphine), until the end of 2024.

A Braeburn media statement says that orphan drug designations are intended to treat rare conditions with small, underserved populations, and not conditions such as opioid use disorder that affect more than 2 million Americans. It notes that in 1994 FDA granted orphan drug status to a different buprenorphine drug for opioid use disorder (Mylan’s Subutex [buprenorphine sublingual tablets]) and has now “grandfathered” that orphan designation to Sublocade without revisiting the 1994 data or considering Sublocade’s current eligibility as an orphan drug, simply because the developer of both Subutex and Sublocade is the same.

Braeburn also contends that the information and assumptions submitted to FDA in 1994 were flawed and that treatment of opioid use disorder has changed considerably in the last 25 years.

The petition says that under the Orphan Drug Act, a drug must either treat a rare disease or condition that is commonly defined as affecting fewer than 200,000 people in the U.S. or, in very rare cases, treat more than 200,000 patients but with no reasonable expectation that the sponsor will recover the costs of developing and marketing the drug. It says the Invidior application fails both tests because that are millions of people with opioid use disorder and the drug is expected to be a highly profitable blockbuster.

“Because the current marketplace already provides adequate incentives for development of Sublocade in terms of huge expected profits,” Braeburn says, “Sublocade is not eligible for the special incentives reserved for bona fide orphan drugs.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome