An opioid-dependence treatment being developed by BioDelivery Sciences International (NASDAQ:BDSI) is on track for a New Drug Application filing in the second half of 2012, making it a contender to compete against current market leader Reckitt Benckiser (LSE:RB).
Raleigh, North Carolina-based specialty pharmaceutical company BDSI announced positive preliminary results from a clinical trial that studied how its drug candidate is absorbed, distributed, broken down and excreted from the body. BDSI is aiming to commercialize a product that combines buprenorphine with the abuse-deterrent agent naloxone as a treatment for opioid dependence. A bioequivalence study of the investigational treatment is on target to start in December; BDSI expects results in the first half of next year.
“If the results from this pivotal study are positive, we could be in a position to submit a New Drug Application (NDA) for BEMA buprenorphine/naloxone in the second half of 2012,” Dr. Andrew Finn, BDSI’s executive vice president of product development, said in a prepared statement.
BDSI says that the U.S. market for people dependent on prescription opioids is nearly 2 million people. The most widely prescribed opioid dependence treatment is Suboxone, a product from U.K.-based pharma company Reckitt Benckiser that combines bupenorphine and naloxone. RB also markets Subutex, another product that offers the same combination of drugs. Suboxone and Subutex generated more than $1.1 billion in 2010 sales for RB.
Some patients have expressed concerns about the length of time it takes for Suboxone tablets to dissolve, as well as about its unpleasant taste. BDSI aims to compete with a product that could improve upon both points. The buprenorphine/naloxone combination BDSI is developing uses the company’s BioErodible MucoAdhesive (BEMA) technology, which delivers drugs through a small piece of film placed on the inside of the cheek. The film dissolves quickly as it delivers the drug. BDSI has already commercialized Onsolis, a product that uses the BEMA technology to quickly deliver the pain-killing drug Fentanyl to patients with breakthrough cancer pain.
Suboxone, an orphan drug, has exclusivity in Europe until 2016. But the product lost that protection in the United States in 2009. To mitigate expected generic competition, RB worked with New Jersey firm MonoSol Rx to develop a product that delivered the drug combination through a film placed under the tongue. The film received U.S. Food and Drug Administration approval in August 2010 and RB launched its new Suboxone film product last September.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Suboxone film is expected to displace Suboxone tablet sales because it dissolves more quickly and has a less objectionable taste than the tablet. In first-half 2011 financial results, RB said its Suboxone film had captured 41 percent of the U.S. market.
BDSI says it believes that its BEMA technology may offer a “convenient alternative to Suboxone.” But with growing sales of RB’s Suboxone film, BDSI may be going head-to-head against an RB film that is established in the U.S. market rather than offering an alternative to an RB tablet the U.K. company has already acknowledged will suffer from generic competition.
