A Swedish pharmaceutical company says it will soon seek approval from the U.S. Food and Drug Administration for a new medication to treat opioid dependency. Two clinical trials have been completed on the drug, called OX219, and Orexo says it received “positive feedback” about the studies during a meeting this month with the FDA.
“It is very good news for Orexo. Our meeting with FDA was constructive and we received a general confirmation of the approaches we have taken in developing OX219 for the U.S. market,” says Anders Lundström, CEO of Orexo. “And it is also very good news for the two million people, who suffer from dependency of opioid painkillers in the U.S. Many are not treated today and I do think that we can offer a good alternative to the current treatment.”
Currently the only oral drug available on the U.S. market to treat opioid addiction is Suboxone. Like Suboxone, OX219 contains the opioid buprenorphine, combined with naloxone to prevent abuse. The opioid effects of Suboxone are limited and the drug is used to wean addicts from more powerful narcotics such as Vicodin, OxyContin, oxycodone, and hydrocodone. Naloxone is added to Suboxone to block opioid receptors in the brain and central nervous system.
Orexo claims its formulation is superior to Suboxone because the OX219 tablet is smaller, dissolves faster and has a better taste.
When asked to compare OX219 to Suboxone, 77 percent of the participants in one study (41 out of 53) preferred OX219. From previous market research and experience, Orexo says it has learned that taste, mouth feel and dissolve time are important attributes for oral drug delivery, which can influence patient compliance to treatment.
Providing an alternative to Suboxone could be lucrative for Orexo. Suboxone sales reached $1.3 billion in the U.S. in 2011 and sales continued to rise by 12.1% during the first quarter of 2012.
Orexo estimates sales of OX219 in the U.S. could reach $300 to $500 million annually.
According to Orexo, the FDA said its two clinical studies of OX219 were adequate to support a new drug application and no further studies were needed. The company still needs to submit technical information about production of the drug at a U.S.manufacturing facility. Orexo said it would complete technical documentation during the third quarter of 2013.
Orexo, which is headquartered in Uppsala, Sweden, is an emerging specialty pharmaceutical company that specializes in drug reformulations.