Opana ER – a long acting opioid painkiller, to be pulled from the markets as per FDA directive

By Dr. Ananya Mandal, MDJun 9 2017

The US Food and Drug Administration this Thursday (8th June 2017) directed pharmaceutical company Endo Pharmaceuticals to remove one of its powerful opioid painkillers Opana ER, that provides a long term relief of pain but also poses a risk of drug abuse.

According to FDA officials, this is the first instance when an opioid medication has been asked to be removed from the market due to the concerns of the drug leading to “the public health consequences of abuse”. FDA Commissioner Dr. Scott Gottlieb has clarified that there is currently an “opioid epidemic” which could be called a public health problem in a large scale. There is a massive degree of opioid misuse and abuse among the general public he said. Necessary steps should be taken to stop this menace. He explained that drugs of this nature need to be stringently regulated and their use is to be strictly on the basis of whether their benefits outweigh their risks. This could target their “potential for misuse and abuse”, he said.

Opana ER contains oxymorphone hydrochloride in a formulation that can have a longer duration of pain relief lasting for several hours. It has been prescribed in pain that is more severe that requires round-the-clock, daily, long term opioid therapy. The FDA approved it for this use in 2006. This drug came under the scanner in 2015 when it was the main culprit preferred by many addicts in a centre of an HIV outbreak in Indiana. One of the other often abused drugs is OxyContin. Oxymorphone is twice as powerful as OxyContin.

Many experts including Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University have lauded this effort and believe several other opioids too need to come off the market.

Endo Pharmaceuticals, the drug makers have formulated Opana ER in a special way by coating it with a hard cover that makes it difficult to crush. The drug is supposed to release the effective opioid in the blood stream slowly and steadily throughout the day to provide pain relief. This has been made to prevent abuse. However, addicts have gotten past this hurdle and are crushing it all the same and taking the drug all at once to get one major high. This could be dangerous to say the least. The formulation was changed in 2012 after which the addicts began to inject the drug. Sharing needles while using this drug has led to spread the HIV infection which happened in the outbreak at Indiana in 2015 where 142 people were tested positive.

This latest decision from the FDA has come after a review of all the data gathered by the company after the drug has been in the market. This is called post-marketing surveillance data. This data showed that earlier people were snorting the drug and now after change of the formulation, they are injecting it. This poses a risk of spread of blood borne diseases such as HIV, Hepatitis B and C etc. There is in fact a known serious outbreak of Hepatitis C linked to use of this drug said the Agency. The FDA subjected the decision to a vote this March by an independent panel of experts. The experts voted 18-8 that this change in formulation of the drug has failed to make it safer and the benefits do not outweigh the risks of this drug.

Endo Pharmaceuticals spokespersons have said that they are evaluating the options and reviewing the situation to opt for an “appropriate path forward”. Opana ER brought in $158 million in sales for Endo last year. This was a 10 percent reduction from 2015 said trade analysts while its shares fell.