FDA Approves Buprenorphine (Probuphine) Implant for Opioid Replacement Therapy

LOS ANGELES, May 31, 2016 /PRNewswire/ -- Probuphine – a first-of-its-kind buprenorphine implant for use by those dependent on opioids – has received approval from the FDA. The same drug has previously been available both as a pill form and as a film that dissolves under the tongue. Proponents of Probuphine, which was developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, say that the implant offers a host of advantages over other delivery methods.

Photo - http://photos.prnewswire.com/prnh/20160527/373132

Photo - http://photos.prnewswire.com/prnh/20160527/373133

"The opioid abuse epidemic is now receiving the national attention it deserves," remarks Registered Addiction Specialist Clare Waismann. "Between 2000 and 2014, the rate of opioid overdose shot up 200%.  Approximately 2.5 million Americans battle addiction every day.  At Waismann Method Medical Group, we believe the stigma associated with drug abuse and dependence should be eliminated. What patients need is compassion and medical intervention to treat what is increasingly being understood as a reversible condition and not a chronic disease."

As a rapid opiate detox center with a nearly 20-year history of results, Waismann Method Medical Group supports the availability of more options, so long as doctors and patients have all the facts. Implants do have some attractive benefits. For instance, they cannot be easily removed and sold on the black market. Patients need not worry about dose timing or missing doses. Regarding the effectiveness and safety, a clinical trial in 2015 showed that Probuphine performed at least as well as buprenorphine pills. In the study, 12% of participants relapsed, compared with the typical rate of 28% with pills.

On the other hand, critics point to the possible high price of Probuphine as a barrier to those who could see the most benefit. The company says the implants will be priced competitive with other competitive injectable opioid treatments in the market, which can cost $1,000 per month. A month's supply of buprenorphine pills costs less than $200. Behshad Sheldon from Braeburn Pharmaceutical, says the company will offer rebates and collaborate with providers and insurers in an attempt to make the drug more affordable.  

Another factor to consider is that Probuphine, like many similar medications already on the market, does not actually treat opioid physical dependence. Instead, drugs like Suboxone – which contains buprenorphine – are opioids themselves. However, unlike typical drugs of abuse, these replacement opioids produce less euphoria and help those dependent on the drug to avoid withdrawal symptoms and cravings. For some patients not yet ready to be opioid-free, replacement therapy can be a useful treatment, and Probuphine could be a promising new option.

"Like any medical treatment, each individual needs to be evaluated before a course of treatment is indicated," says Waismann. "Medical, psychological and social aspect needs to be well understood. Professionals in the field of drug abuse need to stop treating the symptom (addiction) and start focusing on the individual behind it. Today, we can treat and reverse opiate dependence; but for a lasting recovery, individualized mental health care needs to be available and accessible. The implant will give time for at-risk individuals to be adequately assessed and prepare for an effective opioid detoxification in conjunction with psychosocial support."

The Waismann Method® for rapid detox and medical opiate detoxification is a highly personalized approach. An effective medical detoxification is the core component of a full-spectrum program; along with counseling and psychosocial support to achieve freedom from opioid dependence.

About the Waismann Method® 

The Waismann Method® was developed in the late 90s and has only one exclusive location, based in Southern California. Almost two decades later, we have established a superior reputation worldwide for achieving exceptional results with unparalleled safety protocols for medical opiate detoxification. Our success is mainly due to our commitment to outstanding care, individualized attention, Quadruple Board-Certified Medical Director (Michael H. Lowenstein, MD), JCAHO Accredited Hospital, and our comprehensive Private Recovery Center. Since our inception, we have assisted thousands of individuals in achieving a healthy recovery.

Contact:
Clare Waismann
310-205-0808
Email

SOURCE Waismann Method Medical Group