Results from a recently completed Phase 3 double blind study may pave the way for FDA approval of a new drug delivery system for treating opioid addiction. With further development, the same technology may also be harnessed for administration of pain medications. Probuphine®, developed by Titan Pharmaceuticals, is a matchstick-sized buprenorphine implant that delivers a steady dose of the medication for 6 months after insertion under the skin. Lead investigator Richard Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai, commented, “If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option.” The study findings were presented recently at the annual meeting of the American Society of Addiction Medicine.
In comparison to the currently available formulation of buprenorphine, marketed as Suboxone®, the new implant technology offers a number of advantages. Patients do not need to remember to take a pill, and the dosage is controlled, with little risk of overdose, abuse, or opportunity for diversion. The Phase 3 study reported that over 85% of patients who received the implant remained free of illicit opioids, compared to 72% of patients who took buprenorphine orally via once-a-day sublingual strips. FDA has announced its intent to reach a decision on approval of Probuphine by May 27, and escalating pressure to address the national epidemic of opioid abuse may also spur a positive outcome. A rule change proposed by the Obama administration would double the number of patients that a doctor can treat with buprenorphine, from 100 to 200.
Read about other implantable devices, here.
Read a news story about the study findings here.
More information about Probuphine, from the manufacturer’s website, may be found here.
Posted on April 25, 2016