While the abuse-deterrent formulation (ADF) of Purdue Pharma LP’s Oxycontin (oxycodone hydrochloride) extended-release tablets may have reduced abuse of the opioid pain drug by non-oral routes, it did not meaningfully reduce the overall abuse of the product or the risk of overdose, the FDA’s Drug Safety and Risk Management Advisory Committee and its Anesthetic and Analgesic Drug Products Advisory Committee concluded Sept. 11 after two days of presentations and discussions of the results of four required post-approval studies.

The joint committees voted 20-7 that the evidence showed the reformulation reduced non-oral abuse of the product, but many panelists said the evidence showing that effect was weak to moderate. When asked whether the ADF version of Oxycontin reduced overall abuse or the risk of overdose, 26 panelists voted no on both questions, according to Cortellis.

Part of the problem is that most opioid abuse occurs orally, but the Oxycontin reformulation, like most ADFs that have been approved, was designed to reduce abuse via intranasal or injection routes. While recognizing that ADF technology can’t make an opioid drug abuse-proof or nonaddictive, the FDA has encouraged the development of formulations that could meaningfully deter all relevant forms of abuse, including swallowing a tablet or capsule, which is how the drugs are often designed to be taken.

The panelists also pointed to an unintended consequence that can have grave public health consequences: users switched from the Oxycontin ADF to heroin abuse at an increased rate. That transition moves users from a drug with predictable dosing and ingredients to unpredictable products that cause far more morbidity.

Public comments on the topic should be submitted to Docket No. FDA-2020-N-0982 by Oct. 13.

FDA advises on getting back to business as usual

Although the U.S. is still in the throes of the COVID-19 pandemic, it’s time for biopharma manufacturers to start thinking about transitioning back to business as usual. That’s the gist of a guidance the FDA released Sept. 11.

The guidance, which will remain in effect for the duration of the public health emergency, describes how to evaluate and prioritize the remediation of manufacturing activities that were necessarily delayed, reduced or otherwise modified to maintain production and the drug supply during the pandemic.

Measures such as quarantines and social distancing may have been implemented across some companies to prevent the spread of COVID-19. Such measures – coupled with employee illness and absenteeism, travel restrictions, site closures and supply chain disruptions – impacted normal manufacturing operations and current good manufacturing practice activities, the FDA said.

The guidance recommends a quality risk-management approach, prioritizing activities related to the production of drugs at risk of shortage, to help manufacturers resume normal operations.

ICER evidence report targets ulcerative colitis treatments

The Institute for Clinical and Economic Review (ICER) released an evidence report assessing the comparative clinical effectiveness and value of targeted immune modulators that treat ulcerative colitis. Included in the ICER report are: Humira (adalimumab, Abbvie Inc.), Simponi (golimumab, Johnson & Johnson), Remicade (infliximab, Johnson & Johnson), Renflexis (infliximab-abda, Merck & Co. Inc.), Inflectra (infliximab-dyyb, Pfizer Inc.), Xeljanz (tofacitinib, Pfizer Inc.), Stelara (ustekinumab) and Entyvio (vedolizumab, Takeda Pharmaceutical Co. Ltd.). The report will be reviewed at a virtual public meeting of the California Technology Assessment Forum on Sept. 24, 2020.

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