In recent years, subcutaneous (under the skin) implantable devices have been developed to deliver a number of medications for various health conditions, in a sustained release method. One of the newest implant applications is treatment of addiction and alcoholism.
Implantable drug delivery devices offer several advantages over conventional oral or parenteral dosage methods, useful in treating addiction. Implantable devices can ensure controlled, sustained release of a therapeutic agent over a given period of time, without levels that fluctuate over time, as with other delivery methods.
Another advantage is improved patient compliance and convenience, since an implant cannot be lost, stolen or forgotten by the patient.
In January, Probuphine the only long-acting FDA-approved implant for the maintenance treatment of opioid addiction, came on the market in the U.S.
Developed by San Francisco-based Titan Pharmaceuticals, Inc., Probuphine 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 buprenorphine, as part of a complete treatment program. Physicians can insert the implant in a patient’s upper arm during an outpatient office procedure.
Prior to Probuphine, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a patient’s cheek until it dissolved.
Braeburn Pharmaceuticals CEO Behshad Sheldon — whose firm markets the product in the U.S. and Canada — told Forbes.com that Probuphine was developed “to address serious risks associated with oral buprenorphine, including poor compliance, misuse, diversion and accidental pediatric exposure.”
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, according to the manufacturer.
Probuphine is not suitable for everyone with opiate dependence, Sheldon notes. “It is indicated for clinically stable patients taking a low to moderate dose of buprenorphine, specifically 8mg or less per day.”
After receiving the FDA approval in 2016, Braeburn began training healthcare providers to perform the Probuphine insertion and removal procedures.
A single Probuphine implant costs $5,000, with additional costs for followup care. It’s covered by most private and public health insurance plans, which the FDA acknowledged in a recent statement, saying “expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic.”
In November, Titan announced it had entered into an agreement with an Italian firm to commercialize Probuphine in the European Union (including the United Kingdom and Northern Ireland), Switzerland, Norway, Iceland, Liechtenstein, Bosnia, Serbia, Montenegro, Macedonia and Albania.
The other implant on the market for treatment of opiate addiction is a naltrexone delivery device developed by Los Angeles-based BioCorRx, used to treat both opiate addiction and alcoholism. Approved by the FDA in 1984, naltrexone is an opioid antagonist which reduces physical cravings.
BioCorRx provides naltrexone for addiction in conjunction with life coaching, under its Start Fresh program. Patients have a higher success rate when the naltrexone is combined with coaching, the company says.
In 2016, BioCorRx announced a new R & D initiative aimed at gaining U.S. Food and Drug Administration (FDA) approval for its naltrexone implant, which is inserted into the abdomen and lasts several months. Even without FDA approval, naltrexone have been widely used in Europe and also the U.S., even though the lack of FDA clearance means insurers won’t cover it.
BioCorRx’s naltrexone implant is biodegradable, which the manufacturer contends gives it an advantage over Probuphine implants, which must be removed after six months.
BioCorRx is also testing its naltrexone implant as a treatment for obesity. In October, BioCorRx launched a pilot weight loss program, in collaboration with Atlantis Medical Wellness & Weight Loss Center in Silver Spring, Md.