Lisa Henderson
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For the post-surgery patient in recovery, the drug addict in ER, late-stage cancer patients, and the many who suffer from
chronic pain, the FDA is now addressing real-world opioid use by instituting a class-wide REMS. As noted in July's View from
Washington column by Jill Wechsler, there was a recent public meeting on what this REMS for extended-relief opioid medicines
will look like. This class covers 24 brand and generic drugs that contain fentanyl, hydromorphone, methadone, morphine, oxycodone
or oxymorphone. The meeting discussed the balance between access to pain relief for those who need it and the potential for
drug abuse, addiction or death. A REMS draft out of this meeting is anticipated later this year.
In the meantime, on July 16, the FDA approved Onsolis, a fentanyl buccal soluble film, which included the first opioid REMS.
Onsolis is not an extended relief, also called long-acting, product so it does not fall under the class-wide REMS mentioned.
BioDelivery Sciences International (BDSI) and its commercialization partner, Meda Pharmaceuticals, will market Onsolis for
cancer patients, 18-years or older who currently receive and are tolerant of opioid therapy for persistent cancer pain, and
are suffering from breakthrough pain. The film is applied to the inner lining of the cheek, and as such, the companies claim
that it more quickly addresses breakthrough pain because of its onset of action.
The NDA for Onsolis was submitted in October 2007, along with a RiskMAP, mere days after REMS became effective under FDAAA.
The FDA determined a REMS was needed, and BDSI met with the FDA November 2008. It submitted its REMS on December 12, 2008,
where Onsolis was placed under a six-month review period, then approved. I asked BDSI executives if they thought their REMS
is representative of what the long-acting opioid class REMS could look like. Andrew Finn, PharmD, executive vice president
of product development, said, "I suspect some elements of our REMS will be incorporated into the long-acting opioid REMS."
You can read the Onsolis REMS here http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000REMS.pdf. It is a formidable plan that includes at its backbone, an implementation system called the Focus program. The Focus program
is managed by an outsourced vendor for the registration and dispensing of Onsolis. The short list: patients, health care providers,
pharmacists and pharmacies must register and adhere to certain requirements into Focus before Onsolis can be dispensed. But what about the patients whose quality of life is dependent on their medication? Would the machinations required to access
such important pain medicine unintentionally place a restriction on those who need it most? "Nobody should have difficulty
to access the pain medication," said BDSI President and CEO Mark A. Sirgo, PharmD. He surmised, "With the long-acting opioids,
physicians aren't going to be able to avoid it. They won't prescribe another product because they want to avoid the paperwork.
It is something that everyone is going to have to do."
Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com
http://www.appliedclinicaltrialsonline.com/
