Pros and Cons of Bunavail Approved by FDA

Pros

  •  Twice the bioavailability of Suboxone

    teen on pills then heroin

    Pills Lead to Heroin All Too Often

  •  Promising alternative to methadone
  •  Treatment includes psychiatric therapy

Cons

  • Causes respiratory issues
  • Can cause death

Bio Delivery Sciences International’s new drug application has reached the final phase of approval by the FDA. Their supplemental application (sNDA) for Bunavail can step out of the management phase for opioid addiction patients and begin the use of the drug for treatment of opioid addiction.

Bunavail has twice the bioavailability of Suboxone film, which has increased it’s marketability ten fold and and therefore an attractive alternative for bottom line of the manufactures.

 

Bioavailability –  the proportion of a drug or other substance that enters the circulation when introduced into the body. When a drug is injected it has 100% bioavailability. Other means of administration have less than 100% bioavailability such as oral methods.

Bunavail will be administered to patients that are just beginning recovery from opioid dependency. This is a major step in the right direction for the addicts who seek a break from dependency that may have otherwise not found relief from transitional drugs like Methadone.

The company offers a comprehensive package of recovery support through counselling and psychiatric therapy along with administering of Bunavail.  The advantages are promising for the recovering addicts  and it will be a shift in the methods used by the pharmaceutical community via the melding of medication and hands on personal analysis.

Some Drawbacks

There are still drawbacks of Bunavail, which as promising as it could be it has stirred some speculation.  It has been shown to affect respiratory function and in some cases death by overdose through the synergistic effects when combined with benzodiazepines, various tranquillizers and or alcohol.  As well withdrawal symptoms similar to that of heroin are seen with the decreasing dose.

Withdrawal issues are not unfamiliar to this family of drugs and can be controlled through proper dose. The most common of the side effects are the withdrawal symptoms in the form of headaches, fatigue and inability to sleep.  Sweating and constipation have both been noted in the studies and do raise concerns when considering the cost benefit analysis of Bunavail.

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