The Food and Drug Administration this week approved the first buprenorphine implant for the treatment of opioid dependence.
Designed to provide a low-level dose of buprenorphine—a drug commonly used to treat addiction to painkillers—for six months, Probuphine is an alternative option to orally administering the drug. A therapeutic dose of buprenorphine is expected to be reached within 24 hours following insertion of the implant.
“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Dr. Robert M. Califf said in a press release.
There were 18,893 deaths involving prescription opioids in the country in 2014, up 16% from 2013, according to the National Center for Health Statistics (NCHS). There were 10,574 heroin-related deaths in 2014, up 28% from 2013.
The technology, developed by Titan Pharmaceuticals, Inc., a San Francisco-based pharmaceutical company specializing in the treatment of serious medical disorders, enables healthcare providers to subdermally insert the implant in the upper arm of an individual during an outpatient office procedure.
Dr. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing and chief medical officer at Phoenix House, a drug treatment facility, told this contributor that he’s pleased to see this treatment finally become available.
“Improved adherence is the chief advantage over sublingual buprenorphine,” he said.
“We have heard from patients and doctors that Probuphine is an attractive treatment option,” Braeburn CEO Behshad Sheldon told this contributor via an interview. “Probuphine was developed to address serious risks associated with oral buprenorphine including poor compliance, misuse, diversion and accidental pediatric exposure.”
Probuphine is being marketed by Titan and Braeburn Pharmaceuticals, which is headquartered in Princeton, New Jersey. The treatment is expected to be commercially available this summer. There’s no official word on specific pricing, but Sheldon did confirm that “Probuphine will be priced lower than other long-acting medications currently on the market.”
An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.
Common side effects from the treatment include implant-site pain, itching and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.
“It’s important to note that Probuphine will not be right for all people with opioid dependence,” Sheldon said. “It is indicated for clinically stable patients taking a low to moderate dose of buprenorphine, specifically 8mg or less per day.”
Braeburn Pharmaceuticals will begin training healthcare providers to perform the Probuphine insertion and removal procedures. “Approximately 2,250 providers are registered to attend a training session within the six weeks following FDA approval,” Sheldon said. “We have capacity to train up to 3,000 providers within this six-week period. We will have capacity to train a total of 4,000 providers by the end of 2016.”
May 27, 2016