FDA relaxing restrictions on opioid constipation drugs

The following is the text of the news release issued by the Department of Health and Human Services.

Washington, D.C.—As part of our response to the overdose epidemic, the Department of Health and Human Services is taking several actions to address the urgent need for more medicines that treat patients experiencing the disease of withdrawal, known as opioid-induced constipation.

Opiates, such as prescription opioids, such as hydrocodone, oxycodone, and morphine, and illicit opioids, such as heroin, help us feel full, or relieve pain. But when these drugs are taken chronically, for long periods of time, they leave us feeling sluggish and sometimes, uncomfortable. These sensations can make it difficult to take a bowel movement, making it more likely that we’ll need to use the toilet frequently, causing unintentional illness.

Lax restrictions on the supply of these medicines have been blamed for contributing to the increasing number of overdose deaths—especially in high-poverty, urban areas. As a result, the FDA is lifting the prescribing restrictions on many opioid-induced constipation medicines starting this week.

“As more patients have suffered and died from opioid-induced constipation, the FDA has been hard at work improving access to these important medicines. These actions will help make it easier for Americans struggling with opioid-induced constipation to get the medication they need,” said Jeffrey Shuren, M.D., M.P.H., M.S., chair of the FDA’s Drug Safety and Risk Management Advisory Committee.

With the end of the patient’s initial pain medication prescription, many patients experience chronic constipation resulting from taking an opioid or other medication that suppresses the bowel movements. Some take several different drugs over time and even have to change their long-term drugs to find medication that works well.

The FDA approved drug Orphaerin to treat opioid-induced constipation in 1994. This was the first drug of its kind in a major depressive disorder indication approved by the FDA. Orphaerin showed promise in clinical trials and became commercially available in 1996. This drug was the first drug approved in the U.S. for treating opioid-induced constipation. But since those early days, the need for treatment has grown.

In March 2016, the FDA issued an opioid-induced constipation and inadequate adequate treatment Safety Communication to warn clinicians of drug interactions and deaths from these drugs.

In October 2016, the FDA announced new guidelines for opioid-induced constipation. The new guidelines announced that the treatment of opioid-induced constipation should be based on the type of medication used to treat an existing condition. Additionally, the guidelines suggested that ongoing analysis should be performed every six months to monitor whether the management of opioid-induced constipation in patients using Opana ER resulted in a patient death.

The new guidelines recommended that doctors, pharmacists, and dispensers should provide access to Orphaerin through a preferred generic alternative, which now is available to improve patient access. The new recommended generics are contained in the list of approved Opana ER generic alternatives on the FDA’s Pharmacovigilance Web site, .

Today, we are expanding the Opana ER pharmacy network to allow it to make this alternative (Bretanyl) available to prescribers and providers seeking to use this opioid-induced constipation medication to treat an existing condition for which they have been using an existing opioid. This will improve patient access and increase the amount of time needed between use of an opioid and the time an opioid-induced constipation medication is needed.

“We have been working with regulators and our manufacturers to explore new ways to use existing medicines to address this population,” said Jeffrey Shuren, M.D., M.P.H., M.S., chair of the FDA’s Drug Safety and Risk Management Advisory Committee. “We are bringing more new medicines to the market to help people who struggle with opioid-induced constipation, even as the epidemic continues to claim millions of lives.”

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