The rejection comes about a month after the painkiller was cleared by an FDA advisory committee.
Shares of Mallinckrodt PLC are down nearly 9 percent in premarket trading after the company announced the U.S. Food and Drug Administration (FDA) rejected an opioid painkiller designed to be abuse-deterrent.
Mallinckrodt said its specialty generics subsidiary SpecGx LLC received a Complete Response Letter from the FDA regarding the New Drug Application for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets. The tablets were designed for the management of severe pain where alternative treatments have proven to be inadequate.
In the letter to SpecGx, the FDA said that some parts of the NDA required additional evaluation in order for the company to move forward with the application. The opioid painkiller, MNK-812, was designed to deter intravenous and intranasal abuse.
Matt Harbaugh, president of the specialty generics division, said they are evaluating the FDA’s letter and plan to request a special meeting with the regulatory agency to further discuss the issue.
We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we’re disappointed by the FDA’s decision, we will continue to pursue a pathway to try to gain approval of the drug,” Harbaugh said in a statement.
The rejection of MNK-812 comes about a month after the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the opioid painkiller. During the vote, the committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse and 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse.
During that November meeting, there were concerns raised over the potential abuse of the opioid medication. Oxycodone is one of the types of opioids that have been highly abused in the epidemic of opioid abuse that has swept the country in recent years. According to the U.S. Department of Health and Human Services, 116 Americans die daily from opioid overdoses. Several drug companies, such as Mallinckrodt, have sought to make it more difficult for addicts to abuse their opioid painkillers.
Last year, the FDA asked Endo Pharmaceuticals to remove its reformulated Opana ER from the market after it was shown the reformulated medication did not deter abuse. Opana ER was initially approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Six years later the company changed the formulation of Opana ER in order to make it more resistant to physical and chemical manipulation from those hoping to abuse the drug.
Mallinckrodt, along with Endo, Johnson & Johnson, Purdue Pharmaceuticals and other manufacturers of opioids have been the target of lawsuits from state and local governments over the marketing practices of the opioids.
Earlier this month Mallinckrodt announced that it intends to spin its SpecGx business off into a new company next year. The spinoff plan that will create two independent publicly traded companies. One will be focused on “innovative specialty pharmaceutical brands,” while the other company will be concentrated primarily in “niche specialty generic products and API manufacturing.”
