BioDelivery Sciences International (NASDAQ:BDSI) has started testing how its experimental opioid dependence treatment is handled by the human body as it moves forward with its plans to break into the billion-dollar market for opioid dependence drugs.
Based on the pharmacokinetic testing results, Raleigh, North Carolina-based BDSI will choose doses of its BEMA Buprenorphine/Naloxone to compare with the current leading opioid dependence treatment, Reckitt Benckiser (LSE:RB) product Suboxone. A safety study will follow. BDSI expects to file a new drug application for its opioid dependence product in late 2012 or early 2013.
BDSI hasn’t developed a new opioid dependence drug. BEMA Buprenorphine/Naloxone combines two already approved compounds: buprenorphine and abuse-deterrent agent naloxone. That’s the same combination that forms RB’s Suboxone, which along with Subutex, another RB opioid dependence product, generated more than $1.1 billion in 2010 sales. But BEMA Buprenorphine/Naloxone will use BDSI’s drug-delivery platform, a small piece of film that administers medicine as it dissolves after being placed on the inside of the cheek. Suboxone is placed underneath the tongue.
Because BDSI is not developing a completely new chemical entity, the company aims only to show that the product using its drug-delivery technology is essentially the same, or bioequivalent, to Suboxone. BDSI’s plan to file an NDA late next year is a faster timetable than if the company had developed a completely new drug requiring three phases of clinical trials. BDSI plans to file its NDA under the 505(b)(2) pathway, which only requires a company to show bioequivalence to comparable products already on the market. BDSI aims to start the bioequivalence testing in January.
“We believe we are on course to become one of the first products to compete with Suboxone, a product with sales in excess of a billion dollars annually and currently without competition,” CEO Mark Sirgo said in a statement. “We believe our BEMA delivery technology can address the challenges that have been encountered by other potential competitors to Suboxone up to this point.
BDSI could use some good news. In September, the company disclosed that another product candidate, BEMA Buprenorphine, failed in a phase 3 trial studying chronic pain. The company said at the time it would pursue another set of phase 3 studies in an effort to win approval for that product. Like all BDSI products, BEMA Buprenorphine uses the same drug-delivery platform. BDSI successfully commercialized cancer pain treatment Onsolis using that drug-delivery technology. After the BEMA Buprenorphine phase 3 failure, BDSI should have better luck with the opioid dependence candidate. Bioequivalence should be an easier mark to hit than showing statistical significance compared to a placebo in a clinical trial.