FTC Sues Drug Makers for Oxymorphone Monopoly

By Pat Anson, PNN Editor

It was in 2017 that Endo Pharmaceuticals – under pressure from the Food and Drug Administration -- stopped selling Opana ER, an extended-release version of the opioid painkiller oxymorphone. Opana had been reformulated by Endo to make it harder to abuse, but the FDA maintained the tablets were still being crushed, liquefied and then injected by illicit drug users.

Although Opana has been off the market for nearly four years, a legal battle still rages over sales of generic oxymorphone and whether Endo conspired with another drug maker to control the market for oxymorphone.

This week the Federal Trade Commission sued Endo, Impax Laboratories, and Impax’s owner, Amneal Pharmaceuticals, alleging that a 2017 agreement between Endo and Impax violated antitrust laws by eliminating competition for oxymorphone ER.

It’s the second time the FTC filed complaints against Endo, Impax and Amneal for allegedly creating an oxymorphone monopoly.

“The agreement between Endo and Impax has eliminated the incentive for competition, which drives affordable prices,” Gail Levine, Deputy Director of the FTC’s Bureau of Competition said in a statement. “By keeping competitors off the market, the agreement lets Impax continue to charge monopoly prices while Endo and Impax split the monopoly profits.”

According to the FTC complaint, Opana ER generated nearly $160 million in revenue for Endo in 2016 and was the company’s “highest-grossing branded pain management drug.” Endo explored bringing another oxymorphone drug on the market to replace its lost revenue, but ultimately decided to partner with Impax, which had the only extended-release oxymorphone drug on the market.. Their agreement allowed Endo to share in Impax’s oxymorphone profits, as long as Endo did not bring another generic tablet on the market.

“The purpose and effect of the 2017 Agreement is to ensure that Endo, the gatekeeper to competition in the oxymorphone ER market, has every incentive to preserve Impax’s monopoly. By doing so, it eliminates any potential for oxymorphone ER competition, allowing Endo and Impax to share in the monopoly profits. As a result, patients have been denied the benefits of competition, forcing them and other purchasers to pay millions of dollars a year more for this medication,” the FTC complaint alleges.

The 2017 agreement between Endo and Impax arose from a breach of contract case relating to a patent settlement between the companies over Impax’s generic version of Opana ER, in which Endo paid Impax more than $112 million not to compete. In 2019, the FTC ruled that settlement was an illegal "pay-to-delay" agreement.  

Both Endo and Amneal deny there was any effort to create a monopoly in their 2017 agreement.

“It is Endo’s position that the Agreement had no adverse impact on actual or potential competition.  At the time of the Agreement, the U.S. Food and Drug Administration had asked Endo to withdraw reformulated Opana ER from the market for safety reasons and Endo had publicly announced its intention to comply with the FDA’s request,” Matthew Maletta, Endo’s Executive Vice President and Chief Legal Officer, said in a statement to PNN.

“Significantly, as Endo has explained to the FTC, the Company has not launched or licensed any new opioid product(s) since that time, and the FTC’s theory that Endo would do so in the current litigation environment but for the Agreement is preposterous.”

“Far from being anticompetitive, the 2017 Amendment resolved a dispute between the parties that could have kept Impax's lower-priced generic product off the market entirely,” Amneal said in a statement. “We are confident there is no unlawful restraint in the 2017 Amendment, because nothing in the agreement prevents Endo from competing, and we intend to vigorously defend against the FTC’s claims.”

The FTC decision to sue Endo and Amneal a second time was approved on a split 3 to 2 vote by the agency’s commission. The complaint seeks monetary relief and a permanent injunction to prohibit the companies from engaging in similar conduct.

Extended-released oxymorphone is approved for the treatment of moderate to severe pain.  

Drug Maker to Stop Sales of Opana ER

By Pat Anson, Editor

Endo International has agreed to voluntarily remove Opana ER from the market, one month after the Food and Drug Administration said safety risks posed by the pain medication outweigh its benefits. Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone.

“Endo International continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse,” the company said in a statement.

“Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed.”

If Endo had not agreed to stop Opana sales, the FDA would have taken steps to require its removal by withdrawing approval for the drug. The company said it would work with the FDA to remove Opana “in a manner that looks to minimize treatment disruption for patients” and to give patients time to consult with doctors about other alternative painkillers.

The FDA action is the first time the agency has taken steps to stop an opioid painkiller from being sold. Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, hepatitis C and a blood clotting disorder spread by infected needles.

Next week the FDA will meet with “external thought leaders” to review the effectiveness of other painkillers made with abuse deterrent formulas, which make medications harder for addicts to crush or liquefy for snorting and injecting.

FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers 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,” Gottlieb said last month.

“I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones.

Endo said it will incur a pre-tax impairment charge of $20 million in the second quarter of 2017 to write-off the remaining book value of Opana.  Sales of Opana reached nearly $159 million in 2016.

FDA Wants Opana ER Sales Stopped

By Pat Anson, Editor

The U.S. Food and Drug Administration today asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns about safety risks when the tablets are liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold -- and oddly it has more to do with preventing HIV and Hepatitis C than it does in preventing opioid abuse.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, MD. “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.”

Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone. It was first approved by the FDA in 2006 for the management of moderate to severe pain.  In 2012, after numerous reports that it was being abused and sold on the black market, Opana was reformulated by Endo to make it harder for addicts to crush or liquefy.

That same year, over a dozen cases of a serious blood clotting disorder and Hepatitis C in intravenous drug users were linked to the reformulated Opana in Tennessee. But it took another five years for the FDA to act.

In March, an FDA advisory panel voted 18-8 that the benefits of reformulated Opana no longer outweighed its risks. The agency found“a significant shift in the route of abuse” from snorting to injection. Injecting Opana was associated with outbreaks of HIV, Hepatitis C and a blood clotting disorder called thrombotic thrombocytopenic purpura. All can be spread intravenously by infected needles.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

The FDA has requested that Endo voluntarily remove Opana from the market. Should the company refuse to do so, the agency intends to take steps to formally require its removal by withdrawing approval.

"Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward," the company said in a statement. "Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients."

According to Bloomberg, sales of Opana  reached nearly $160 million last year, about 4 percent of the company’s total revenue.