FDA Approves First Implant to Help Patients who are Addicted to Opioids
Probuphine provides patients with six months of constant medication that helps to curb their dependence on pain killers
Federal regulators have approved a medical implant for patients who suffer from opioid dependence.
Probuphine is the first buprenorphine implant approved by the Food and Drug Administration (FDA) and when along with other forms of treatment has shown to help patients overcome their addiction.
The implant is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of the medication, which until now was only approved as a pill or a dissolvable film. While the pill and the film are effective, the FDA says both can be lost or stolen or patients can forget to take their daily dose. The implant, on the other hand, provides six-months of constant medication.
Made by Titan Pharmaceuticals, Probuphine is intended to be used as part of a complete treatment program that includes counseling and psychosocial support. The implant is considered a medication-assistant treatment (MAT), which along with counseling and behavioral therapy, can help people overcome opioid addition. The medications help to reduce withdrawal symptoms and the desire to use without the cycle of highs and lows associated with opioid misuse or abuse. The pleasurable effects of opioids are also reduced, lessening the desire to take them.
Methadone and naltrexone are other common MAT drugs.
Probuphine is implanted under the skin on the inside of the upper arm and can only be administered by a doctor who underwent specific training because it must be surgically inserted and removed.
In clinical trials 63 percent of patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those to responded to the dissolvable version of the drug.
The most common side effects include: include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.
The drug's safety has not been studied in patients younger than 16 and older than 65 years old.
"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 Robert M. Califf said in written news release.
For more information about Probuphine, visit the FDA website.