Braeburn plans $20m NC plant; awaits FDA decision on subdermal buprenorphine
The private Phase III pharma firm is investing $20m (€18m) into the new site in Durham County – close to Research Triangle Park (RTP) - over the next five years, and says it will create 52 new manufacturing and R&D specialist jobs.
VP of Commercialisation and Manufacturing, Craig Brown, said in a statement the plant would help “provide patients with addiction, chronic pain, and serious mental illness with medications to treat their chronic disease.”
The plans were welcomed by North Carolina Governor Pat McCrory, who said last week: “Braeburn Pharmaceuticals joins a long list of life sciences companies that have made North Carolina the nation’s No. 1 state for bio-manufacturing jobs.”
He added: “This company and the pioneering work it plans to do here will make a difference in the lives of patients and families around the world while also adding value to the economy and community of the Research Triangle.”
Subdermal buprenorphine delivery
Braeburn’s lead candidate is a buprenorphine HCl implant named Probuphine, intended to treat opioid dependence.
The product is a subdermal implant designed to deliver the opioid – currently available in daily-dose pill and film formulations - continuously for six months following a single treatment.
It uses the continuous drug delivery system ProNeura, developed by Braeburn’s partner Titan Pharmaceuticals.
The platform consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and the drug substance. This results in a solid matrix that is placed subdermally in the arm of an outpatient, and removed in a similar manner at the end of the treatment period.
The advantages of delivering buprenorphine this way include increased patient compliance and decreased risk of diversion, the firm says
The product has been submitted to the US Food and Drug Administration (FDA) and a Committee voted 12 to five in favour of approving Probuphine back in January. Braeburn and Titan await a final decision by May 27, after the FDA put back its action date from February.
