35 U.S. States Sue British Drugmaker Indivior Over Marketing of Opioid
September 23, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – British drugmaker Indivior is under fire this morning for attempting to block generic drugs from entering the market and challenging its drug, Suboxone, which is used to treat patients addicted to heroin and other opioids. So far, 35 U.S. states and the District of Columbia have filed a lawsuit against the company, Reuters reported this morning.
Shares of Indivior, sold on the London Stock Exchange, plunged nearly 16 percent in Friday trading, but have climbed back up and as of 2:14 p.m. London-time, are down only 7 percent. The lawsuit alleges the company attempted to “corner the market” on the treatment for opioid addiction. Suboxone, an oral treatment, was initially approved by the U.S. Food and Drug Administration (FDA) in 2002. It did not have patent protection, but the FDA gave the drug a seven-year protection by assigning it orphan drug status. According to the lawsuit, as Reuters explained, when the seven year status was ending in 2009, Indivior, along with Indiana-based MonoSol Rx, conspired to block generic drugs from challenging Suboxone. The lawsuit alleges that Indivior attempted to get prescribers to switch patients from the pill form to a dissolvable oral strip. That sublingual film version of Suboxone was licensed to Indivior by MonoSol Rx, the lawsuit said.
After the dissolvable strip was licensed to Indivior, the company attempted to persuade federal regulators to approve the new version, claiming that “the tablet posed high exposure risks to children,” Reuters reported. Then, the company urged the FDA to block generic tablet versions of Suboxone, using the same argument that tablets are greater risks to children. Although the FDA rejected those arguments and ultimately approved generic tablet versions of Suboxone, the lawsuit says many patients had already switched over to the sublingual form—of which there is no generic version. The tactic is often referred to as product hopping, where small changes are made to an approved drug in order to keep generics off the market.
Indivior said in a statement that it has been notified of the lawsuit and intends to “vigorously defend its position.” Indivior spun off from Reckitt Benckiser as a standalone company in 2014. When Suboxone was first developed, Indivior was established as the opioid addiction division.
Opioid addiction has reached epidemic proportions in the United States. According to the U.S. Department of Health and Human Services, 78 Americans die daily from opioid overdoses.
In August, Indivior announced positive top line results of a Phase III trials of RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support. RBP-6000 is a subcutaneous (SC) long-acting monthly depot injection that delivers a sustained-release formulation of buprenorphine. Barring any unforeseen issues, the company anticipates submitting the drug for FDA review in early 2017, it said in a statement.