When is opana coming back

The FTC sued Endo and Impax in January for engaging in similar anticompetitive conduct concerning the same drug product. In June , the FDA asked Endo to voluntarily withdraw its drug from the market because of safety concerns about the reformulated version of Opana ER that Endo launched in After deciding to withdraw its reformulated Opana ER, Endo explored bringing another oxymorphone ER drug to the market or partnering with a third-party generic company as a way to replace its Opana ER revenues.

This agreement allowed Impax to exercise and maintain monopoly power in the market for FDA-approved oxymorphone ER tablets, according to the complaint. The FTC previously found that the agreement between Endo and Impax was an illegal reverse-payment settlement. The complaint charges the defendants with violating Sections 1 and 2 of the Sherman Act, which constitutes unfair methods of competition in violation of Section 5 of the FTC Act. The idea is that the drug's effects can be clearly demonstrated in comparison with placebo because it is already known to work for all of the patients.

The results of those trials helped get the drug approved by the FDA in But the FDA's own medical review of the drug acknowledged that, given the enriched study design, "one could argue that the results may not be generalizable to the wider chronic pain population. Nelson said the enriched trials "find the people who are most likely to respond to a drug and not suffer from side effects.

FDA spokesman Pahon said companies use a variety of strategies to select those in the general population in which the effect of a drug can be more readily shown. Opana is not the only opioid approved using enriched enrollment. In , drugmaker Zogenix used the strategy to win approval for Zohydro , a high-dose, hydrocodone-only drug that was originally approved without any abuse-deterrent mechanisms. The FDA approved the product despite its own advisory committee on pain drugs voting against it.

Source Reference: Peniston JH, Gould E "Oxymorphone extended release for the treatment of chronic low back pain: A retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use" Clin Ther ; DOI: Disclosures Endo Pharmaceuticals funded the enriched enrollment trials for Opana.

Primary Source Clinical Therapeutics Source Reference: Peniston JH, Gould E "Oxymorphone extended release for the treatment of chronic low back pain: A retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use" Clin Ther ; DOI: Opioid addiction continues to be a serious problem across the U.

A report released this week from the Centers for Disease Control and Prevention found that pain-relief prescriptions in the United States vary widely from county to county , with 6 times more opioids-per-resident in regions with the highest prescribing rate compared to the lowest.

Counties in northern California, southern Nevada, and parts of Tennessee, Kentucky, and West Virginia had some of the highest per-capita rates. Contact us at letters time. Getty Images. By Amanda MacMillan. Get our Health Newsletter. Sign up to receive the latest health and science news, plus answers to wellness questions and expert tips.

After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder thrombotic microangiopathy.

This decision follows a March FDA advisory committee meeting where a group of independent experts voted that the benefits of reformulated Opana ER no longer outweigh its risks.