FDA Approves New Opioid Addiction Treatment

FDA Approves New Opioid Addiction Treatment

A new addiction treatment drug approved by the Food and Drug Administration will be less likely to be diverted and abused by addicts, according to addiction treatment experts.

The FDA on Friday approved a new drug application for Bunavail, a buprenorphine film strip developed by BioDelivery Sciences International (NASDAQ: BDSI) for the treatment of heroin and opioid addiction.

Image courtesy of BioDelivery Sciences International

Image courtesy of BioDelivery Sciences International

“Opioid addiction is a serious issue that can often be difficult to treat,” said Tim Lepak, President of the National Alliance of Advocates for Buprenorphine Treatment. “I believe people addicted to prescription opioids and heroin will welcome Bunavail as a novel treatment option.”

Over three million Americans with opioid dependence have been treated with buprenorphine. Most used heroin and prescription opioids recreationally. Only about five percent of pain patients who take opioid pain medications long term develop an addiction, according to the National Institutes of Health.

Bunavail is similar to another film strip sold by Reckitt-Benckiser under the brand name Suboxone, but the buprenorphine in Bunavail comes in smaller doses of 2.1 milligrams, 4.2 mg, and 6.3 mg. The recommended target dosage of Suboxone is 16 mg of buprenorphine daily.

The dosage is smaller in Bunavail because buprenorphine is absorbed into the body faster through the use of an advanced drug delivery technology.

“Patients who want to abuse or divert buprenorphine formulations will not have much interest in this product. The amount of buprenorphine in each of the dosage forms of Bunavail is less than the presently available preparations. This is indicative of its superior bioavailabity,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area.

“For patients who are serious about getting well, this is a welcome preparation. Clinics like ours that use buprenorphine preparations for relatively short periods of time will certainly see use of this preparation.”

In 2012, patients filled about 9 million prescriptions for buprenorphine, many not realizing they were taking another opioid to treat their opioid addiction. Buprenorphine is a narcotic, a potentially addicting painkiller that was first approved as a treatment for opioid addiction in the U.S. in 2002. When combined with naloxone, which blocks opioid receptors in the brain, the two drugs can be used to help wean addicts off opioids such as heroin, Vicodin, OxyContin, and hydrocodone.

Although praised by most addiction treatment experts, some fear that buprenorphine is overprescribed and may be fueling a new epidemic of diversion, addiction and death.

Many addicts have learned they can use buprenorphine to maintain their addiction, not to treat it. Buprenorphine won’t get them “high” but it will help smooth out withdrawal symptoms between highs. As a result, it has turned into a street drug that is prized by some addicts more than heroin itself.

Buprenorphine was one of the drugs found in the apartment of actor Philip Seymour Hoffman after his fatal overdose. He did not have a prescription for it.

“We are still faced with the larger problem of patients using buprenorphine formulations as a way to continue using heroin and they are taking the pharmaceutical route even further. Many of the patients of buprenorphine preparations are getting scripts for benzo (benzodiazepine) and continue using opioids,” Menzies wrote in an email to National Pain Report.

Both the Bunavail and Suboxone film strips are taken orally. But while Suboxone is designed to be taken under the tongue (sublingual), Bunavail is meant to be taken between the cheek and gums. Clinical studies by BDSI found that patients prefer the taste of Bunavail over Suboxone and reported fewer side effects such as constipation.

BDSI plans to launch Bunavail in the fall of 2014 and anticipates sales of up to $250 million. The company plans to target nearly 5,000 physicians in the U.S. who are responsible for about 90 percent of the prescriptions for buprenorphine products.

Suboxone has long dominated the $1.7 billion market for buprenorphine, although several competitors have emerged in recent years with different formulations of the drug, ranging from menthol flavored pills to buprenorphine implants.

Authored by: Pat Anson, Editor

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Also won’t chronic pain patients be able to be eligible for medical marijuana which appears to be sailing through congress?.It has been one of the few bills that they have agreed on.It lowers inflammation at a very high percentage.

That should read a difference between opoid addiction and opoid dependency

You people that write these medical reports are missing one very profound thing though.There is a difference between opoid addiction and opoid addiction.I have a seperated spine ,three herniated discs in the lower back and two to three in the neck.The disc at L2 is completely dessicated,disintegrating into my body.For two years after filing a Retirement Disability I have been involved in pain management with a major hospital.It took four epidurals and a buprenorphine patch of 10 to controlmy pain,and on bad days I take an Aleve.I do not get high.I amnot thresholding.I do not need a higher dosage.With the FDA’s report about epidurals having more of a risk then they thought(go to the FDA website)it seems now that once you get comfortable they want you to lower the med.I have been vetted,gave blood,urine,do not doctor shop,and am sitting here writing with a stiffness,but not with the debilitating neuropathy that I had in 2009 to 2012.I was a letter carrier for 27 years .Wore a 45 pound bag on my right side and the radicular pain is all occupational injury.My question is this.I cannot be operated on because it would be two surgeries,the neck and the lower back.At least this is what a good neurosurgeon told me.He said there was a chance that my whole spine would cave in.I do not feel that another epidural will make a difference and last longer than three to four months which is the average time that I receive relief from the pain. Why can’t I choose to stay on the 10 Butras Patch,as long as I am visiting a hospital every month?What is the danger in a Butrans patch at the same dosage for the rest of my life?

Steve M

Below 300 mcg/day, buprenorphine is an analgesic, but above 2 mg/day, it blocks opioids, the naloxone is irrelevant because it can’t be absorbed orally. They only include naloxone to stop people from injecting Suboxone.

Buprenorphine doesn’t give people good feelings like oxycodone at any dose.