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Bunavail Is Approved By FDA To Treat Opioid Addiction

on Monday, 01 December 2014. Posted in Breaking News

Opioid addiction is on the rise in America, mostly due to an increase of prescription painkiller abuse and addiction. Opioid is a class of drugs that come from the opium poppy, or synthesized to act like it, that affect the opioid brain receptors, dulling pain sensation and causing a feeling of euphoria.

Vicodin, morphine, OxyContin, methadone, heroin, and codeine are commonly abused opioid drugs. There are more than two million people with opioid dependence who require some type of treatment to overcome their addiction.

Buprenorphine as an Addiction Treatment

Many recovery professionals turn to buprenorphine to help treat the withdrawal symptoms and cravings as an addict goes through detox. There is some debate as to the efficiency of the treatment, as many feel it is switching one addiction for another.

Because buprenorphine is an opioid drug, it causes many of the same effects as the other drugs, but they last longer, so a person needs lower doses. However, there is still a high risk of abuse, and many professionals feel that using buprenorphine in addiction treatment is merely exchanging one addiction for another.

Despite the debate, buprenorphine has become a popular treatment for opioid dependency, and with the approval of Bunavail by the FDA, doctors now have another choice of medication when prescribing buprenorphine.

What is Bunavail?

Bunavail buccal film is a new drug created by BioDelivery Sciences International Inc. to help treat opioid addiction. It combines buprenorphine and naloxone and uses a unique inside the check delivery system to improve the absorption of the buprenorphine, so it can be administered a lower dosage.

This helps reduce the risk of abuse or addiction to buprenorphine, which is one of the biggest arguments against the use of buprenorphine treatment in opioid addiction recovery.

Why Inside the Cheek?

Buprenorphine is typically administered sublingually, and must dissolve under the tongue to enter the bloodstream. However, this method of administration makes it difficult to talk, swallow, or perform other normal activities throughout the day.

With the new inside the cheek film, the patients will be able to act normally while the medication is consistently absorbed into the bloodstream. The insdie the cheek technology is a patented by the company and known as BioErodible MucoAdhesive (BEMA).

The Benefits of Bunavail

Bunavail is set to have twice the bioavailability of the drug when compared to Suboxone, the current market leader in buprenorphine medication. Because of the improved bioavailability, the ideal plasma concentrations of buprenorphine can be met with half the dosage of Suboxone and other similar dugs.

It is the only current buprenorphine and naloxone formula for buccal (or inside the cheek) administration. In a Phase 3 clinical study with 249 participants, Bunavail was found to have better efficacy and safety than Suboxone, demonstrated by a high retention rate and low frequency of positive urine tests during the twelve-week trial. Participants also found it easy to use with fewer side effects.

FDA Approval

With the FDA approval on June 6, 2014, for the New Drug Application, BioDelivery Science is set to launch Bunavail late in the third quarter of 2014. It will be one of the first to compete directly with the Suboxone sublingual film.

It provides a new option for opioid dependent patients to overcome their addiction with minimal withdrawal symptoms, cravings, and side effects. It remains to be seen whether it will likewise have a high risk of abuse, as has happened with Suboxone.

Regardless, buprenorphine should never be used as a stand-alone treatment option for addiction. Instead, it should be part of a comprehensives treatment that includes psychotherapy and education to treat the behavioral components of addiction, as well as the physical.

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