Braeburn Pharmaceuticals is not out to revolutionize therapy for the neurological and psychiatric diseases it focuses on. The Princeton, NJ-based biotech has one approved product for an implant that is designed to meter out a steady dose of buprenorphine — a well known generic — over 6 months for opioid addiction. And now it’s in the process of teeing up a similar FDA application for another implant that could provide a 6-month dose of risperidone to schizophrenics after running a small Phase II/III study with 50 patients.
The study reported out today involved 50 stable patients who were transferred off their oral doses and then observed to see how well they did with the implant. And researchers said that the implant performed as expected, maintaining proper serum levels of the drug needed to manage symptoms of the disease. The logical theory is that an implant would offer a more reliable supply of the drug, without relying on the patients stay on their scheduled doses.
The next step involves a late-stage safety study with plans to follow up with the FDA on a new drug application later in 2017.
Braeburn also recently posted positive top-line results from a Phase III trial of weekly and monthly CAM2038, an injectable formulation of buprenorphine for opioid addiction, comparing it to the daily dose.
That all amounts to the kind of reliable, low-risk profile that the folks at Apple Tree Partners, which owns Braeburn, had thought that investors would back with a $150 million IPO earlier in the year. But after filing the S-1 in January the company came back a few weeks later and shrugged off the effort, saying the market timing wasn’t right. Braeburn spent a little more than $50 million on R&D in the first 9 months of 2016, according to the S-1.
Said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals:
“This clinical program in schizophrenia represents a strong complement to our initial therapeutic focus in addiction and pain. Looking ahead, we expect results from a Phase III risperidone safety study later this year and are targeting a year-end 2017 filing of a New Drug Application seeking approval for the risperidone implant.”
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