Drug Development

FDA slaps down Braeburn on opioid addiction drug, putting Indivior and Alkermes in strong position

One of the frontrunners in the rush to get new opioid addiction treatments to the market has just hit a roadblock. Just days before its PDUFA date, Braeburn Pharmaceuticals got a complete response letter from the FDA in lieu of an approval.

Mike Derkacz

The company is developing a formulation of buprenorphine that’s injected weekly and monthly. The drug is called CAM2038, and it previously got fast track and priority review designations from the FDA. On the promise of this program, Braeburn just closed a $110 million mezzanine round earlier this month with backers including Deerfield and RA Capital Management.

Braeburn was hoping to be the first to market with a monthly injectable buprenorphine, but the FDA said it needs more information before it moves the application forward. Now, it looks like the industry’s leader Indivior may well beat them to the chase.

Indivior makes the well-known opioid addiction drug Suboxone, which was long taken as daily strips that dissolve on the tongue. The drug contains a mild opioid that helps stymie withdrawal. But in November, Indivior got the FDA’s OK for a buprenorphine extended-release monthly injection, which goes by the brand name Sublocade. Indivior is poised to launch the product in Q1 of this year.

Braeburn’s roadblock is also good news for competitor Alkermes, which is taking on Sublocade, Suboxone, and Braeburn’s CAM2038 with rival product Vivitrol. Alkermes’ product contains no addictive opioids whatsoever, which could be a competitive selling point to physicians and patients concerned about addiction. Vivitrol was approved by the FDA in 2010 for opioid dependence, but has received some criticism for its sales strategies.

Although we know the CRL will slow down Braeburn, it’s tough to gauge the impact. Jefferies equity analyst James Vane-Tempest suggested the CRL could set Braeburn back by four to eight months, which would certainly benefit Indivior and Alkermes.

When asked what “additional information” the FDA is requesting, Braeburn demurred. A company spokesperson said the company had no further comment beyond the press release.

“Braeburn will continue to work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible,” said Mike Derkacz, president and CEO of Braeburn, in the release. “Opioid addiction is one of the worst public health crises in our nation’s history. We are committed to introducing this innovative treatment to better meet the overwhelming needs of patients.”


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