US long-acting opioid REMS at least a year away
This article was originally published in Scrip
A recent US FDA regulatory action suggests implementation of a single risk evaluation and mitigation strategy (REMS) for the class of long-acting opioids and immediate-release methadone is well over a year away.
The FDA recently published a notice reopening until October 19th, 2010, the comment period for stakeholders who wish to weigh in on a series of issues related to a class-wide REMS. The agency originally outlined the issues for which it sought comment in April and held a public hearing in late May. The comment period closed on June 30th, but the agency cited "continued public interest" in recently deciding to reopen it for another year.
The long duration of the reopened comment period suggests the development and implementation of a class-wide REMS is still far from fruition.
Testimony at the May meeting from manufacturers, pharmacies, healthcare providers, patients, survivors of drug overdoses, the pain community and risk management consultants revealed the challenges and complexities that lie ahead for the agency and companies that are working to develop a single REMS for drugs prescribed to 26 million Americans annually (scripnews.com, June 1st, 2009).
Commenters at the meeting said a REMS should be pilot-tested, include technologies for tracking diversion and able to measure the programme's downstream effects, including whether the scheme is leading to increased abuse of other types of drugs.
25 brand and generic companies that market extended-release opioids and methadone have formed an industry working group, which presented its REMS proposal at the public meeting. Methadone manufacturers also proposed their own separate REMS.
The agency continues to seek public input on the potential elements of a REMS, including prescriber and pharmacist education and certifications, and a patient-prescriber agreement. Other issues include how the programme should be designed to minimise the burden on the healthcare system and patients, and how the FDA should evaluate the REMS to ensure it is achieving its goals.
Given the long development time for the REMS, the agency is not waiting until a class-wide risk management scheme is in place before approving new long-acting opioids.
BioDelivery Sciences/Meda's Onsolis (fentanyl buccal soluble film) was approved in July with a restricted distribution programme; similar measures will be required for other currently marketed transmucosal fentanyl products, which are separate from the drugs to be covered by the long-acting opioid class REMS. In August, the FDA approved King Pharmaceuticals' Embeda extended-release capsules (morphine sulphate plus naltrexone hydrochloride) with an interim REMS comprising a medication guide and a communication plan, pending completion of the class-wide scheme.
Last month, an FDA advisory panel endorsed a proposed REMS for Neuromed Pharmaceuticals' long-acting opioid Exalgo (hydromorphone extended-release, licensed to Covidien) and backed approval of Purdue Pharma's reformulated OxyContin (oxycodone extended-release) as potentially less susceptible to abuse and manipulation than the currently marketed version.