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OxyContin Abuse-Deterrent Formulation Has Addicts Switching To Heroin

 
• By Brenda Sandburg

New England Journal of Medicine report notes an increase in heroin use among patients with opioid dependence following the introduction of reformulated OxyContin; Purdue post-marketing study also finds an increase in heroin-related calls to poison control centers.

Purdue Pharma LP’s abuse deterrent formulation of OxyContin (oxycodone HCl controlled-release) has helped reduce abuse of the opioid since its introduction in August 2010 but led addicts to turn to other drugs, particularly heroin, according to a study reported in the New England Journal of Medicine.

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More from Post-Marketing Regulation & Studies

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
• By Eliza Slawther

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Pharma Industry Wants Easier Access To England’s Revamped NHS Data Sharing System

 
• By Eliza Slawther

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

More from Product Reviews

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.