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BUNAVAIL™
(Buprenorphine/Naloxone buccal film)

Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services.


Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999-2010)

 

Rates of prescription painkiller sales, deaths and substance abuse treatment admissions<br />(1999-2010)

 

Opioid dependence is a medical diagnosis that is characterized by the inability of an individual to stop using opioids, both prescription opioids such as morphine, hydrocodone and oxycodone, as well as illicit opioids such as heroin, even when it is in the best interest of the individual to do so. Opioid dependence is a complex medical condition that often requires long-term treatment and care. The treatment of opioid dependence is important to reduce both the associated health and social consequences and to improve the well-being and social functioning of people affected.

 

The main goals of treating persons with opioid dependence are to reduce dependence on illicit drugs, reduce morbidity and mortality, improve physical and psychological health, reduce criminal behavior, facilitate reintegration into the workforce and education system and to improve social functioning. The ultimate achievement of a drug free-state is the ideal and ultimate objective, but this may not be feasible for all individuals with opioid dependence, especially in the short term. As no single treatment is effective for all individuals with opioid dependence, diverse treatment options are needed, including psychosocial approaches and pharmacological treatment.


Buprenorphine/naloxone is widely used in the treatment of opioid dependence and is marketed as Suboxone® (buprenorphine/naloxone sublingual film). Suboxone® which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option. Accordingly to Wolters Kluwer, U.S. sales of Suboxone® exceeded $1.4 billion in 2013 and continue to steadily grow. Buprenorphine works by reducing the craving and withdrawal effects from the dependent opioid, and the opioid antagonist naloxone, is present to deter abuse.

 

BioDelivery Sciences is developing BUNAVAIL™ (Buprenorphine/Naloxone buccal film) previously referred to as BEMA® buprenorphine/naloxone or BNX, which uses BDSI's proprietary BioErodible MucoAdhesive (BEMA®) delivery technology, for the maintenance treatment of opioid dependence. BUNAVAIL™ would provide BDSI with an opportunity to compete in the large and rapidly growing opioid dependence market.

 

BUNAVAIL™ contains the same drug components as Suboxone®, the only currently marketed formulation of buprenorphine and naloxone, and pharmacokinetic studies have demonstrated the ability of the BEMA® technology to deliver doses of buprenorphine needed for the treatment of opioid dependence. BDSI believes BUNAVAIL™ has the potential to offer advantages over Suboxone® and could seize a meaningful share of this rapidly growing market.

 

A New Drug Application (NDA) for BUNAVAIL™ was submitted to the Food and Drug Administration (FDA) on July 31, 2013, and is currently under review.

  

Suboxone® is a registered trademark of Reckitt Benckiser Healthcare Ltd.