Opioid manufacturers have suffered a number of setbacks over the last several weeks. The FDA asked Endo Pharmaceuticals, in June, to stop the sale of Opana ER, an “extended-release” opioid pain reliever (OPR). If not, the agency promised it would no longer approve the drug. Endo indicated it would fully consider the request before acting. Then on July 6th, the company issued a statement saying it would voluntarily eliminate the drug from its inventory. That same day two California counties pursued legal action against Endo, Purdue Pharma and several other companies, claiming, in concert with many others, that big pharma “created false impressions” that the new extended-release (ER) drug would help stop drug abuse.
Opana ER, which was introduced to treat chronic pain for long periods, has been the source of major profits for Endo. In 2017’s first quarter alone, the drug reaped $35.7 million in sales and during the entire fiscal year of 2016, Opana ER brought in $158.9 million, according to the July 6th press release. But now, without the drug, the company will likely lose $20 million.
Despite the FDA’s mandate, Endo maintained that the drug was safe: “Endo remains confident in the clinical research and other data demonstrating OPANA® ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients,” the company said in a press release. Endo’s statement sounds like a repetition of the various mantras spouted by Big Pharma throughout the spiraling opioid epidemic of the last couple decades.
The epidemic is very real. In 2015, over 52,000 people died from overdose and nearly two-thirds of those fatalities were opioid-related. And in 2010, 254 million opioid prescriptions were given out. That’s enough to keep every adult in the US medicated non-stop for 30 days, according to the CDC. Needless to say, opioid substance abuse is a major problem, as 1.9 million people suffered from opioid addiction in 2013, according to the National Institute on Drug Abuse. And if Endo thinks its “abuse-deterrent” technology is a panacea, it is deadly wrong.
In 2012, Endo released one of the first extended-release OPRs, which was developed specifically to diminish the possibility of addicts crushing pills. But, as the FDA observed, the plan backfired. Opana ER led to an increase in opioid injections, which in turn caused HIV and Hepatitis C to spread rapidly in a region of Indiana where opioid abuse is common.
Dr. Janet Woodcock – who heads up the Center for Drug Evaluation and Research at the FDA – said as much in a statement: “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak.” Taking it off the market, she said, “will protect the public from further potential for misuse and abuse of this product.”
And as pointed out in the recent lawsuit, Endo’s reformulation was never acceptable as a substitute for traditional OPRs. In 2013, the FDA sent a letter to the company saying there was zero evidence to show that Opana ER “would provide a reduction in oral, intranasal or intravenous abuse.” Referring to studies Endo refused to reveal, the suit claims the ER drug could in fact “be ground and chewed,” meaning it could still be abused.
Danny Chou, who is representing Santa Clara County in the current suit, said Endo’s ceaseless support of “abuse-deterrent” technology indicates a form of opportunism. “This strategy is trying to take the opioid epidemic and benefit from it,” he told the Washington Post in an interview.
FDA Director Taking Action
The FDA’s request was significant, as it was the first time the agency took action against the opioid industry due to issues of abuse. In the FDA’s press release, Dr. Scott Gottlieb, the current director of the FDA, highlighted the pervasive epidemic as a motivating factor for taking Opana ER off the market: “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Given the immense damage dealt by the opioid epidemic, the recent legal action in combination with the FDA’s decision to remove Opana ER from the market might seem a dim light at the end of a long tunnel.