Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Approves First Medical Device Implant For Opioid Dependence

XTALKS VITALS NEWS

Co-developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, Probuphine is designed to slowly release a low dose of buprenorphine, for a six-month period.

Share this!

May 31, 2016 | by Sarah Massey, M.Sc.

The US Food and Drug Administration (FDA) has approved the first buprenorphine implantable medical device – marketed as Probuphine - for patients with opioid dependence. Tweet: #FDA approves buprenorphine #medicaldevice for #opioid dependence http://ctt.ec/y75et+ Co-developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, Probuphine is designed to slowly release a low dose of buprenorphine, for a six-month period.

While buprenorphine was previously approved to treat opioid dependence, it has historically only been available in the form of a pill or a dissolvable film. While these oral drug delivery methods are effective, they are reliant upon patient adherence to a medication schedule, and the medication can be vulnerable to theft.

For patients who are tolerant to low doses of buprenorphine, the implantable medical device could be a more convenient method for managing opioid dependence. Aimed at reducing prescription opioid abuse, dependence and overdose-related death, the FDA approved Probuphine to increase availability of medication-assisted treatment options.

“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,” said Dr. Robert M. Califf, FDA Commissioner. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”



Medication-assisted treatment utilizes currently-available medications – including methadone, buprenorphine and naltrexone – along with behavioral therapy and counselling, to effectively treat opioid dependence. When patient adherence to a medication-assisted treatment plan is optimized, individuals reduce their risk of death by 50 percent, according to the Substance Abuse and Mental Health Services Administration.

“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

The Probuphine product consists of four small rods that are implanted under the skin of the upper arm. The medical devices are surgically inserted and removed by physicians who are certified under the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program.

A randomized clinical trial of adult patients with opioid dependence was conducted to determine how successful the implanted medical device was at reducing illicit drug behavior. Using both urine screening and self-report measures of illicit opioid use during the six month clinical trial period, the researchers found that 63 percent of patients showed no signs of drug use.

As more medical devices may be implanted in the opposite arm should the patient require further treatment, the FDA is requiring Titan and Braeburn to conduct further postmarketing studies. In addition, the FDA has required the product to carry a black box warning explaining the risks of implant migration, protrusion, expulsion and nerve damage following the insertion/removal procedure.


Keywords: FDA, Opioid, Medical Device


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Amgen Identifies Issue with Patient Access to PCSK9 Inhibitor

March 23, 2017 - Most US patients hoping to get their PCSK9 inhibitor medications covered by their prescription drug plan are being denied, according to two new studied conducted by Amgen.

Featured In: Biotech News


Smartphone App Created Using Apple’s ResearchKit Used to Conduct Asthma Clinical Studies

March 22, 2017 - Researchers at the Icahn School of Medicine at Mount Sinai have conducted a large-scale, observational study of asthma patients using the Apple ResearchKit framework and the Asthma Health app on patients’ iPhones.

Featured In: Clinical Trials News


IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis

March 22, 2017 - According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

Featured In: Drug Safety News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

How to Improve the Speed and Efficiency of Your Clinical Trials


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.